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60601 Checklist 1 Intro _Rev33

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1. E E E E E z o a ig z T T T io K C z A g a o E 5 L C C 5 E 42 Insulation systems with measured temperatures exceeding Class A 105 C based on 40 C ambient comply with UL1446 T20 42 1 Equipment does not attain temperatures exceeding the values given in Table Xa over the range of ambient temperatures per Clause 10 2 1 T 20 O Equipment does not attain temperatures exceeding the values given in Table Xb at 25 C ambient Test Temperatures may be adjusted to 40 C ambient by adding the difference between the UL testing ambient and 40 C to measured temperatures T20 Applied parts not intended to supply heat have surface temperatures not exceeding 41 C 42 3 Note If the specified maximum ambient temperature for equipment operation is specified as less than UL 40 C and with the new ambient the applied part maximum temperature meets requirements it is possible to exceed the 1 C rise limit of the 41 C requirement allowed on a case by case basis 42 3 Item 2 Add the following to the first dash For this clause only low voltage equipment rated at Australia greater than 200 V is regarded as having a maximum rated voltage of 230 V Ke Guards to prevent contact with hot surfaces removable only with a tool ol Eo FIRE PREVENTION ms l 43 Strength and rigidity necessary to avoid a fire hazard 4 OVERFLOW SPILLAGE LEAKAGE HUMIDITY INGRESS OF LIQUIDS CLEANING STERILIZATION AND DISINFECTION fe Equ
2. AAMI BP22 331 AAMI SP9 331 2 Electr tic C tibility Requi ts and Tests 04 93 Ed 2 09 01 Am 1 09 04 Ed 2 1 11 04 TA Ecromagnetie Cu ELT oN WETS I TESS USI 0a 0TA MA0 mon 35 Blankets Pads and Mattresses Intended for Heating in Medical Use 11 96 3 Gen Requirements for Radiation Protection in Diagnostic X ray Equipment 07 94 a p yup 07 34 36 Extracorporeally Induced Lithotripsy 03 97 5 lity and dose for X ray equipment Project Mma gelqualty and dose MATAV EA pMenY DIS Electrically Operated Hospital Beds 10 96 Am 1 12 99 Ed 2 Project 4 P ble Electrical Medical Syst 05 96 Am 1 10 99 Ed 1 1 Consolidated 04 00 3 ae aoe 7 5 foorammabte ElecticalMedicalg stems 03 90 JAR L022 onsolidated 000 ltrasonic Medical Diagnostic and Monitoring Equipment 07 01 Am 1 08 04 Ed 1 1 10 04 Am 2 Project 6 Analysis test and validation of human factors compatibility Ed 1 06 04 eritoneal Dislysis Equipment 06 99 Ed 1 Bilingual 12 03 7 General requirements for multiparameter patient monitoring equipment Project ectromyographs and Evoked Response Equipment 02 98 8 General requirements and guidelines for the application of alarms in Medical Electrical Equipment 08 03 5 ae ik 7 7 41 Surgical Luminaires and Luminaires for Diagnosis 02 00 IEC 60601 2 xx 42 Automatic or Advisor ExtermalDefibrilators Incorporated into IEC 60601 2 4 1 Medical Electron Accelerator
3. For RI Insulation minimum thickness shall be 0 4 mm as long as it is not affected by age or hygroscopic ofala olol ofofo ofolo Kiss folate ofolo oloo RER oloo ofofo ofolo ofolo eee oloo ofofo olo ofolo oloo E MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 25 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations PROTECTIVE EARTHING FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION Accessible parts of Class equipment separated from live parts by basic insulation connected to the protective earth terminal Protective earth terminals suitable for connection to the protective earth conductor Potential equalization conductor Readily accessible Accidental disconnection prevented in normal use Conductor detachable without the use of a tool Power supply cord does not incorporate a potential equalization conductor Connection means marked with Symbol 9 Table DI For equipment without power supply cord impedance between protective earth terminal and accessible metal part lt 0 1 Ohm For equipment with an appliance inlet impedance between protective earth contact and any accessible metal part lt 0 1 Ohm For equipment with a non detachable power supply cord impedance between protective earth pin in mains plug and accessible metal part lt 0 2 Ohm If the impedan
4. O 21 5 DROP IMPACT FOR PENDANT HANDHELD EQUIPMENT T13 55 US Polymeric Enclosures Drop 3 samples 1 22 meters 4 ft 3 times on tile covered cement All Others Drop sample 1 meter 3 times on 50 mm thick hardwood board on cement 1 3 Samples Tape Measure Specified Surface O 21 6 ROUGH HANDLING DROP FOR PORTABLE STATIONARY EQUIPMENT 114 Portable Equipment Drop sample 3 times at lt 10 kg 5 cm 10 50 kg 3 cm gt 50 kg 2 cm A Metric Ruler UO 21 6 ROUGH HANDLING ROLL OFF STEP FOR MOBILE EQUIPMENT T14 Mobile Equipment Roll 0 4 m s 0 1 m s 60 98 ft s or maximum velocity off step 20 mm high 20 times B 0O 22 US IMPACT TEST ON END STOPS T15 Worst case intended specified loading Number cycles amp Conditions Per Table 22 100 US Deviations Scale 0O 24 STABILITY AND TRANSPORTA BILITY T16 10 Tilt least favorable position or 5 Tilt for normal use 10 Tilt for transport with Warning for correct transport position on unit or in manual with Symbol DI 14 on unit m Tape Measure Distance Lifted Width of Base 0 173648 10 28 3 US SUSPENSION SYSTEM WITH SAFETY DEVICES LOADING TEST T17 See 21 3 Defeated suspension systems with maximum normal load from most adverse position No signs of damage to safety catch or restraining means None LJ 28 4 US SUSPENSION SYSTEMS WITHOUT SAFETY DEVICE LOADING TEST See 21 3 Loaded 1 min with the following Safety Factor
5. 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations D N Marking on the Inside of Equipment or Equipment Parts Nominal voltage of permanently installed equipment Maximum power loading for heating elements or holders for heating lamps Dangerous voltage symbol Table DI 6 Replace the existing subclause wit the following The presence of HIGH VOLTAGE PARTS shall be marked with the symbol dangerous voltage see Appendix D Table DII Symbol 6 and in the Korean language Table DI 6 2 ip a Type of battery and mode of insertion Marking referring to accompanying documents used for battery not intended to be changed by the operator Fuses accessible with a tool identified either by type and rating or by a reference to diagram Protective earth terminal Table DI 6 D Functional earth terminal habe De Supply neutral conductor in permanently installed equipment marked N Markings required in 6 2 f h k and I remain visible after connection and are not affixed to parts which have to be removed Markings comply with IEC 445 For permanently connected devices the supply connections are clearly marked adjacent to the terminals or in accompanying documents for small equipment Statement for suitable wiring materials at temperatures over 75 C oj 9 D D N S Do we fe ie amp Statement for suitable wiring materials at temperature s over 60 C D Do 5 Capacitors and or c
6. If connected between mains part and protectively earthed metal parts comply with IEC Publication 384 14 Enclosure of capacitors connected to mains part and providing only basic insulation is not secured to non protectively earthed metal parts ay a oO Aj A a OD p 5 e gt P Capacitors or other spark suppression devices are not connected between contacts of thermal cut outs 56 4 Si UL Y1 Capacitors per IEC 384 are considered equivalent to DI across a barrier This use is not adequate for across the line or line to ground bridging before the mains fuse s Y1 DI 250 Vac max Y2 Y3 X1 X2 BI 250 Vac max Y4 BI 150 Vac max X3 BI 125 Vac max Two capacitors in series forming DI must have identical electrical ratings 6 5 Protective devices which cause disconnection from the supply mains by producing a short circuit not provided in equipment Temperature and overload control devices Thermal cut outs which have to be reset by a soldering not fitted in equipment Thermal safety devices provided where necessary to prevent operating temperatures exceeding the limits aj ala a ojl a C oj a gt D D Audible warning provided where the loss of function caused by operation of a thermal cut out presents a safety hazard Self resetting thermal cut outs and self resetting over current releases operated 200 times or UL Recognized Non self resetting over current releases operated 10 times
7. No wear corrosion fatigue or aging Safety Factor gt 4 Wear Corrosion Fatigue Aging Safety Factor gt 8 Specific elongation at break lt 5 Safety Factor X 1 5 Scale MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 3 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Test CLAUSE TEST OO 29 X RADIATION TEST T19 Measured 5 cm from accessible surfaces Detector window area approx 10 cm 2 0 5 mR h max for tubes over 5 kV Radiation Detector with entry window approx 10 cnf U 42 1 TEMPERATURE T20 42 2 Tested at 25 C or ambient near 25 C until thermal stability Adjust ambient and measured temps for 40 C 42 3 Thermocouples Temperature Meter OO 44 2 OVERFLOW T21 15 Overfill followed by Dielectric Withstand Test Fluid Measure container Dielectric Tester o 443 SPILLAGE T22 200 ml poured over equipment followed by Dielectric Withstand Test Fluid Measure container Dielectric Tester 200 ml 6 76 oz 4 LEAKAGE Water applied by pipette to seals inspect for wetted components Pipette Dielectric tester HUMIDITY PRECONDITIONING 91 95 RH 20 C 32 C IPXO 48 hn IPX1 8 168 hr Dielectric Withstand Test in chamber Leakage Current 1 hr after removing chamber Hum chamber Dielectric tester RMS Volt meter MD network HARMFUL INGRESS OF LIQ
8. 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Power supply cords Not more than one connection to a particular supply mains If alternative supply allowed no safety hazards when more than one connection is made simultaneously The mains plug has only one power supply cord Non permanently connected equipment provided with power supply cord or appliance inlet Power supply cords sufficiently robust to comply with the requirements of IEC 227 designation 53 and IEC 245 designation 53 Polyvinyl chloride insulated power supply cords not used for equipment having external metal parts with a temperature exceeding 75 C Detachable power supply cords unlikely to be detached accidentally impedance of earth contacts presents no safety hazard possibility of replacement by a cord which could make equipment hazards minimized complies with CSA C22 2 NO 21 not smaller than No 18 AWG minimum serviceability of Type SJ for mobile equipment or Type SV for other 57 3b Canada 57 3b Canada 57 3b Canada 57 3b Canada 57 3b Canada 57 3b Canada 57 3b Canada Flexible cord is of type acceptable for application Flexible cord not smaller than 18 AWG relieved from strain including twisting parts by supplementary insulation to strain as long as the phase conductors are in contact with their terminals connected 57 3b USA 57 3b USA 57 4 57 4b 57 4c ere Po Detachabl
9. AND EDGES Rough surfaces sharp corners and edges which may cause injury or damage avoided or covered MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 28 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations STABILITY IN NORMAL USE see appended table 24 Equipment does not overbalance during normal use when tilted through an angle of 10 Equipment overbalances when tilted through an angle of 10 does not overbalance when tilted through an angle of 5 in any position excluding transport carry a warning notice stating that transport should only be undertaken in a certain position in the position specified for transport does not overbalance when tilted to an angle of 10 Equipment or its parts with a mass of more than 20 kg is provided with suitable handling devices grips etc instructions for lifting and handling during assembly On portable equipment with a mass of more than 20 kg carrying handle s is are so situated that equipment may be carried by 2 or more persons EXPELLED PARTS Protective means are provided where expelled parts of the equipment could be a hazard Display vacuum tubes with a face dimension exceeding 16 cm are provided with adequate protection against implosion VIBRATION AND NOISE No Requirements in Base Standard PNEUMATIC AND HYDRAULIC POWER No Re quirements in B
10. P ii Means incorporated to facilitate adequate inspection of cables and anchorages Australia 28 2b iii Cross arms or pivots fitted with adequate stops locknuts grub screws or similar devices to p q p g Australia prevent supported masses from being dislodged 28 Safety device provided where the integrity of a suspension depends on parts which may have hidden defects or on parts having safety factors not complying with Sub clause 28 4 8 8 s fT Safety device has safety factors complying with Sub clause 28 4 2 2 Clear indication to the operator that the safety device has been activated after failure of suspension means Ba S No evidence of damage to a safety catch after test USA N Po Safety catch marking provided pa FO Suspension systems of metal without safety devices 4 fF 4 Safety factors multiplied by 1 5 for metal having an elongation at break of less than 5 2 5 Sheaves sprockets band wheels and guides so constructed that the safety factors maintained till replacement A mass equal to 3 times the element s mass is added at the center of gravity of each element for 4x safety factor The total mass on all the elements is held for 1 minute 8 a o a impaired m OO oses estans mee mpanse 3 l 3 3 3 3 w o ii ieee 4 4 4 4 Hospital Beds In order to be consistent when using the particular standard for beds the same 2x safety factor requirement shall apply for support brackets and the like as apply to
11. current ajo BE ofo fofo ofo fofo ofo fofo fofo HL a HL BE ofo fofo ie ofo fofo Bg BE ki ojo Bg ofo ajo ofo ofo olo MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 26 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations DIELECTRIC STRENGTH Overall compliance with Clause 20 Dielectric strength for equipment per TABLE V Conducted At operating temperatures After humidity preconditioning After sterilization disinfection A ai BI Between live parts and protective earthed accessible parts A az DI Between live parts and enclosure not protectively earthed A b Bl Between live parts and conductive parts separated by BI forming part of DI A c SI Between enclosure and Conductive parts separated from live by BI A e DI Between live parts and SIP SOPs not protectively earthed if SIP SOPs gt 42 4 V peak or 60 V dc A f Bl Between parts of opposite polarity of mains part before mains fuse fuses removed for testing A g BI or SI or RI Between live parts and a metal enclosure lined with insulating material A j Sl Between accessible parts non protectively earthed and foil over power supply cord inside bushings anchors A k DI Between accessible parts non protectively earthed and SIP SOPs if a SIP SOPs gt 42 4 V peak or 60 V dc b leakage c
12. or UL Recognized oa oa oa o o o D D D w w w oa o D w Independent non self resetting thermal cut out provided where a failure of a thermostat could constitute a safety hazard 56 6a Where consequential loss of function caused by operation of a thermal cut out presents a safety Canada hazard both visible and audible warnings provided 5 o e2 o Thermostats with varying temperature settings clearly indicated oa o e2 o Operating temperature of thermal cut outs indicated oa O N Batteries oa o N w Battery compartments oa o N w adequately ventilated oa o Ny w accidental short circuiting is prevented 5 e gt N o Incorrect polarity of connection prevented 56 8 Indicators unless indication provided by other means from the normal operation position indicator lights are used color see 6 7 a Oo oe to indicate that equipment is energized to indicate the operation of non4duminous heaters if a safety hazard could result oa Oo oe oa Oo oo to indicate when output exists if a safety hazard could result oa Oo oe charging mode indicator provided 6 10 Actuating parts of controls 6 10b Actuating parts are adequately secured to prevent them from working loose during normal use 6 10b Controls are secured to prevent the movement relative to scale marking safety related only 6 10b Detachable indicating devices are prevented from inc
13. witing Field wiring Thermal cutoff thermalink Thermal protector for motors Thermostat Transformer Lock Overload Protection Transformer construction only Transient Voltage Surge Suppressor Transistor MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Medical Evaluation Package Breakdown Voltage Providing minimum across nonconductive body Rated V Rated Rated V A IEC 60601 1 with National Deviations NZMT2 U QCRV B i WOYR JU WOYR2 UL KAM WOYR UL KAM WOYR2 OANZ2_ UL L L XCFR2 XCMQ2 L L L L L XGPU2 XAPX2 PIDF2 UL XPTQ2 NWGQ2 XODW2 FGQS2 XOKV2 U a Ch UL 514B UL 1449 UL 61058 IEC 61020 IEC 61058 UL 61058 IEC 60669 IEC 61020 IEC 61058 UL 61058 IEC 61020 IEC 61058 UL 1059 IEC 60947 7 UL 1020 IEC 60691 IEC 60730 UL 506 UL 1950 IEC 60044 IEC 60076 IEC 60742 IEC 60950 IEC 60989 IEC 61050 IEC 61558 Compiled by Brian R Biersach 11 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations i B k Varistor VOM Rated XUHT2 FOWX2 a E A E a a A E a a MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 12 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Pack
14. 0 C have an insulation of heat resistant material 59 1d Soult 59 2 Aluminum wires of less than 16 mm2 cross section not used Connecti ng cords between equipment parts considered as belonging to the equipment 59 2b Mechanical strength and resistance to heat and fires retained by all types of insulation 59 2 b S UL The Ball Pressure test may be waived for UL Classifications if the UL Recognition of the subcomponent covers the concerns for resistance to heat RTI Rating gt 75 9 3 3 Insulation not likely to be impaired by deposition of dirt or by dust resulting from wear of parts Fuse elements replaceable without opening the enclosure fully enclosed in a fuse holder Protective devices between an isolated applied part and the body of the equipment do not operate below 500 V r m s o CE ol Po el Po ol PO o a o Le fel FP O O sppe o C E Ol a o a o O ol Po ol Po ol Po Kel FP O O ol Po O o o es ol Po ol Po o i eeen ol o O Kel Po ol Po ol Po o a MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 42 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Partially sealed oil filled equipment or equipment parts provided with means for checking the oil level CANADA DEVIATIONS FOR DEFIBRILLATION PROOF APPLIED PARTS Creepage distances or clearances of at l
15. 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations INSULATION DIAGRAM Area Insulation Reference Required Required Measured Measured Dielectric Remarks BOP BI SI voltage creepage clearance creepage clearance Voltage RI mm mm mm A Le eae N Le P MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 1 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Overall equipment description accessories to equipment area s equipment will be used intended power supply overall objectives MECA Project Proposal Quote PO from Client to open project Preliminary investigation Anticipated date samples will be ready for testing Anticipated equipment production date UL L 37 amp L 40 forms signed Examine equipment discuss its use accessories interconnection to other equipment construction materials Create Insulation Diagram All components that cross a barrier per insulation diagram must meet creepage amp clearance requirements The working voltage of a barrier is determined by measurement If either both sides of barrier are floating the highest voltages on either side of barrier are summed except where one side lt 25 V Verify power supply certification construction and required fusing for equipment Determ
16. ATING DATA Not Used PROTECTION AGAINST HAZARDOUS OUTPUT Equipment furnishing both low intensity and high intensity outputs provided with means minimizing possibility of a high intensity output being selected accidentally ajojo OOO BEE alate folol afol ofo folate eee eee alate folate nan man aja ei alata BER DLL Beg EEN afata e ojo MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 32 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations ABNORMAL OPERATION AND FAULT CONDITIONS ojn of o m m o o folofolololojojololojo of of o T30 2 1 Equipment is so designed and manufactured that even in single fault condition no safety hazard as described under 52 4 exists see 3 1 and Cl 13 52 1 Note Opening of a PWB trace is not acceptable per 57 8b 52 1 The safety of equipment incorporating programmable electronic systems is checked by applying IEC 601 1 4 52 1 Evaluation to IEC 601 1 4 is only required to mitigate Fire Shock and Mechanical Hazards SI UL for the UL mark Note Safety Hazards Emission of flames molten metal poisonous or ignitable gas in hazardous quantities Deformation of enclosure to such an extent that compliance with this Standard is impaired temperatures exceeding the maximum values shown in Table XII T31 52 5 2 Failure of thermostats presents
17. C 60601 1 X and or Particulars IEC 60601 2 XX as necessary 6 61 Canada 6 61 Canada 6 61 Canada eo 6 61 K Canada Point of connection of gas cylinders is gas specific BE ofo ofo ofo ofo le ae Re Ee ia Ee Re EC Re ee ee Re BE i ee Ee ie E is noninterchangeable is identified MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 22 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations POWER INPUT Power Input Measurements Cannot exceed ratings by more than 15 lt 100W 10 gt 100W BASIC SAFETY CATEGORIES Moved to Appendix A 1 1 REMOVABLE PROTECTIVE MEANS Moved to 6 12 ENVIRONMENTAL CONDITIONS Equipment is capable while packed for transport or storage of being exposed to the conditions stated by the manufacturer Specified Environment Temperature 10 C to 40 C Relative humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa Tables XIX and Xb give maximum temperatures at an ambient of 25 C Table Xa gives maximum temperatures considering an ambient of 40 C Therefore 15 C shall be subtracted from the limits given in Table Xa when using a 25 C ambient Rated voltage not exceeding 250 V for hand held equipment Rated voltage not exceeding 250 V d c or single phase a c or 500 V polyphase a c for eq
18. EC 60950 IEC 60825 1 IEC 60825 2 IEC 60601 2 22 TEC 60825 1 LASER UL 60950 IEC 60950 UL 60950 UL 60601 1 UL 1004 IEC 60034 UL 2111 UL 60950 IEC 60950 UL 1577 IEC 60747 5 VDE 884 Compiled by Brian R Biersach 9 60601 Clause Checklist Rev 33 05 2005 Plugs amp Socket Hospital Grade Power Supply Direct Plug in Brick Power supply cords US Canada Power supply cords International Power Supply Cord Danish Printer PTC Thermistor Device Relay control manual time delay Relay solid state MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Medical Evaluation Package Plugs DK 24a DK 24a with flat phase pin or DK 2 5a Rated V coil V A HP contact Rated V activation A HP contact IEC 60601 1 with National Deviations UL 498 IEC 60884 IEC 60309 1 IEC 60309 2 UL 60601 1 IEC 60950 UL 1310 UL 60950 IEC 60950 UL 817 IEC 60799 CENELEC HD 21 DK 2 la or DK 2 5a 60950 IEC 60950 UL 1434 UL 796 IEC 60603 2 UL 508 IEC 60255 IEC 60730 2 10 IEC 60947 IEC 61810 IEC 61811 IEC 61812 NMFT2 UL 1577 FPQU2 IEC 60747 5 SWIV2 Compiled by Brian R Biersach 10 60601 Clause Checklist Rev 33 05 2005 Strain Relief Surge Suppressor Switch Interlock Switch Power Switch Voltage selector Tape Insulating Terminal block Internal
19. Hz 6 1g Australia 1h Aj Al Al Al Al ll Rated frequency or rated frequency range s Hz Rated power input VA W or A Watts required if power factor gt 0 9 Insert the following sub clause between the second and third sub clauses Equipment for one or several RATED voltage or frequency ranges the RATED input for 220 V 60 Hz or if applicable for 110 V 60 Hz shall be separately marked Power output of auxiliary mains socket outlets if provided Class II symbol if no Protective Earth Table DI 10 Symbol for degree of protection against ingress of water provided Marked Ordinary Equipment or IPX0 IP X X Rating or DI 14 with wording in manual IPX1 IPX2 IPX8 Symbol for protection against electric shock Table DII 1 2 3 If equipment has more than one applied part with different degrees of protection the relevant symbols are clearly marked on such applied parts or on or near relevant outlets Symbol for protection of defibrillation proof applied parts Table DII 9 10 11 6 Symbol 14 from Table DI for defibrillation proof with protection partly in patient cable OOO FO Mode of operation if no marking suitable for continuous operation MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 17 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviati
20. O SEMKO etc Not required for CE Marking Optional CE Marking services for sale in the European Union Assist with your compliance documentation for the Medical Device Directive M DD work with your Notified Body as necessary m MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 2 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations IEC 60601 1 UL 2601 1 TEST CHECKLIST All Tests Conducted at 90 110 Voltage Ratings Except Power Input Test Conducted at Rated Voltage Test CLAUSE TEST O CONSTRUCTION EVALUATION TO Required Spacings per Insulation Diagram Construction Requirements Critical Components Caliper O 6 1 MARKING DURABILITY T1 Rub cotton rag 15 seconds on Labels markings with each Distilled Water Denatured Alcohol Methylated spirits Isopropyl alcohol O 7 1 POWER INPUT T2 At rated voltage stabilized W V or VA recorded Power Analyzer Volts Amps Watts O 15 6 T3 VOLTAGE LIMITATION PART 1 If gt 0 1 uF in mains Voltage measured between supply pins enclosure and earth Oscilloscope or 1 sec Switch box Volt Meter with max O 15 c VOLTAGE LIMITATION PART 2 T4 Residual voltage measured on capacitors circuits after opening enclosure if gt 0 27 uF 120 V or gt 0 07 uF 240 V Oscilloscope O 17 1 DEFIBRILLATION PR
21. OOF APPLIED PARTS T5 17 h2 DEFIBRILLATION PROOF RECOVERY TIME Measurements taken per Fig 50 or 51 Applied to Accessible Parts Oscilloscope O 18 f EARTHING AND POTENTIAL EQUALIZATION T6 IEC UL 25 A or 1 5 x Ratings for 5 sec CAN 30 A or 2 x Ratings for 2 min 30 A AC Power Supply Shunt Volt Meter or Ground Bond Tester O 19 LEAKAGE CURRENT T7 Conducted Before After Humidity amp Abnormals conducted at 110 rated Voltage one side at ground potential Earth Enclosure Patient Patient Aux Patient F Patient SIP SOP True RMS Volt meter MD network U 20 4 DIELECTRIC VOLTAGE WITHSTAND T8 Each Barrier of Insulation Diagram Tested Full voltage held for 1 minute Dielectric HiPot tester O 21a ENCLOSURE MECHANICAL STRENGTH T9 21b Force Test 45 N 625 mm Impact Impact Hammer 0 5 J 0 05 J UL Ball 9 6 cm Impact Test can be waived if UL mechanical abuse test conducted 1 13 5 x energy of UL ball drop Force Gauge Impact hammer or UL Ball O 21 c HANDLE LOADING T10 Load to 4 x Equipment weight for 1 min on each handle add 3 x equipment weight to actual equipment Scale O 21 3 MECHANICAL STRENGTH PATIENT SUPPORT SYSTEM T11 See 21 3 1 35 KN or spec load x required safety factor Load supported for 1 minute See 21 4 Scale UO 21 3 MECHANICAL STRENGTH FOOT RESTS CHAIRS T12 2 7 kN or max load x safety factor 2 in 0 1 m surface area Load supported for 1 minute Scale
22. Package IEC 60601 1 with National Deviations ak a are eae oa oa oa oa 2 O Er LIMITATION OF VOLTAGE AND OR ENERGY Voltage measured one sec after disconnection of the mains plug does not exceed 60V For live parts accessible after equipment has been de energized the residual voltage does not exceed 60 V nor residual energy exceed 2 mJ Marking provided for manual discharging Interlock switches if used must pass a 10 000 cycle test ENCLOSURES AND PROTECTIVE COVERS Equipment enclosed to protect against contact with live parts and with parts which can become live finger pin hook test Exception 5 SIP SOPs on the back of equipment separated from the mains by DI is acceptable Insertion or removal of lamps protection against contact with live parts provided Opening in a top cover positioned that accessibility of live parts by a test rod is prevented 15 c Note UL en o Conductive parts accessible after the removal of handles knobs levers without the use of a tool have a resistance of not more than 0 2 Ohm separated from live parts by one of the means described in Sub clause 17g Parts with voltage exceeding 25V a c or 60V d c which cannot be disconnected by external mains switch or plug protected against contact Removable enclosures protecting against contact with live parts Removal possible only with the aid of a tool Use of automatic device making parts not live when the enclosure is opened o
23. R Biersach 39 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Mains Supply Transformers Switching power supplies conform to CSA Electrical Bulletin 1402C Overheating External to the transformer protective devices connected in such a way that failure of any component cannot render the protective devices inoperative Short circuit of secondary windings not caused excessive temperature Overload of secondary windings not caused excessive temperature The dielectric strength of the electrical insulation of a mains supply transformer such that it passes tests Transformer 5x Dielectric test can be waived for Switch Mode power supplies 57 9 Canada 97 9 1 57 9 1 57 9 1a 57 9 1b 57 92 57 9 2 SI UL 57 9 2 Note UL 57 9 4 57 9 4a 57 9 4a Transformer 5x Dielectric test can be waived if transformer primary and secondary winding varnish is R C OBJS2 Separation of primary and secondary windings separate bobbins or formers one bobbin with concentric windings and having copper screen with a thickness of not less than 0 13 mm 57 9 4a ee concentrically wound on one bobbin with windings separated by double insulation 57 9 4a 57 9 4c SI UL three layers provided that each combination of two layers can withstand the dielectric strength test for reinforced insulation Means provided to prevent displacement of end turns Potted transfor
24. SO 10993 1 Biological Evaluation of Medical Devices Biocompatibility 08 03 8 Endoscopic Equipment Ed 2 08 96 Am 1 07 00 EC 60825 1 Safety of LASER Products Part 1 Ed 1 2 08 01 9 Baby Incubators 12 90 Am 1 10 96 AAMI 1136 331 ANSI UL1998 Software in Programmable Components Ed 2 05 98 Am 1 05 00 Rev 1 05 04 SO 14971 Medical Devices Application of Risk Management to Medical Devices 12 00 Am 1 03 03 20 Transport Incubators 12 90 Am 1 10 96 AAMI 1151 331 CSA C22 2 No 0 4 M1982 Bonding and Grounding of Electrical Equipment Protective Grounding 12 82 21 Infant Radiant Warmers 02 94 Am 1 10 96 EC 60878 Graphic Symbols for Electrical Equipment in Medical Practice Ed 2 07 03 22 Diagnostic and Therapeutic Laser Equipment Ed 2 11 95 Ed 3 Project ASTM F2196 02 Circulating Liquid and Forced Air Patient Temperature Management Devices 10 02 UL 544 Medical and Dental E t Equi tF Date 1 1 2005 Standard Withdraw Date 1 1 2010 23 Transcutaneous Partial Pressure Monitoring Equipment 09 93 Including essential performance Ed 2 12 99 cal aNd DENA EMP MEME UIRMENt hree zE D atek 2005S tandarra iDate 2000 UL 187 X Ray Equipment Equipment Freeze Date 1 1 2005 Standard Withdraw Date 1 1 2010 24 Infusion Pumps and Controllers 02 98 25 Electrocardiographs 03 93 Am 1 05 99 AAMI EC 11 331 26 Electroencephalographs 04 94 Ed 2 11 02 Ed 2 Bilingua
25. TERMINALS AND CONNECTIONS Clamping means of the protective earth terminal Not be able to loosen without the aid of a tool 8 8 component not related to earthing Terminal may be stacked if PE is first connection and secured with lock washer nut before other connections are made 58 2 USA 58 2 Canada Where the protective earth connections are made via a plug or socket device the protective earth connection is made before and interrupted after the supply connections during connection and interrupting in Mains plug receptacle CONSTRUCTION AND LAYOUT Internal wiring 59 1 Canada Connecting cables comply with Canadian Electrical Code Part Installation of connecting cords between parts of equipment in compliance with NEC Cable type acceptable for external interconnection 59 1 USA Cables and wiring protected against contact with a moving part 59 USA lol 1 1 1 7 8 58 8 Note 9 ql 1 59 1b 59 1 Wiring having basic insulation only protected by additional fixed sleeving Components are not likely to be damaged in the normal assembly or replacement of covers Movable leads are not bent around a radius of less than five times the outer diameter of the lead Insulating sleeving adequately secured If the sheath of a flexible cable or cord is used as supplementary insulation it complies with requirements of IEC 227 and IEC 245 and dielectric test Conductors subjected to temperatures exceeding 7
26. TING OF MOTOR CAPACITOR T34 For unattended equipment and capacitors not evaluated to IEC252 Short circuit capacitors open circuit capacitors measuring motor temperatures Thermocouples Temperature Meter O 52 5 9 FAILURE OF COMPONENTS TEST T35 Components short circuited or opened worst case one at atime Temperatures recorded Thermocouples Temperature Meter 0O 52 5 10d HEATING ELEMENT OVERLOAD T36 56 6 Thermostat or Thermal control short circuited operated until thermal stability T37 Thermocouples Temperature Meter O 52 5 10f MOTOR RUNNING OVERLOAD T38 If remotely controlled or operated continuously while unattended oad increased until thermal stability temperatures per 52 5 10 f Thermocouples Temperature Meter OO 52 5 10g SHORT TIME MOTOR RUNNING OVERLOAD T39 If attended equipment not kept on by hand normal load until thermal stability temperatures per Table XII Thermocouples Temperature Meter O 52 5 10h OPEN PHASE PROTECTION T40 For 3 Phase Equipment with Motors One phase of equipment disconnected run until thermal stability Thermocouples Temperature Meter O 55 US MECHANICAL ABUSE BALL DROP TEST T4 For polymeric enclosures and covers only 2 inch stainless steel ball 1 18 Ib dropped from 1 3 meters 51 in on equipmentto give 5 ft Ibs Impact UL Steel Ball MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled b
27. UIDS Per IEC 60529 IP X X followed by Dielectric Withstand Test and inspected for ingress into enclosure IP Apparatus for type of Ingress Dielectric Tester CLEANING STERILIZATION AND DISINFECTION As specified in users manual followed by Dielectric Withstand Test Cleaning solution per manual Dielectric Tester HYDROSTATIC PRESSURE If Pressure x Volume gt 200 kPa and Pressure gt 50 kPa Max Pressure of vessel X Ratio from Fig 38 Pressure or Load Source 50 kPa 7 25 psi 1 61 in PRESSURE CONTROL TEST Safety release Performing rated load for 100 000 cycles Pressure or Load Source INTERRUPTION OF THE POWER SUPPLY Pose no safety hazard None POWER AVAILABILITY TEST To Verify lt 15 W Available to waive enclosure flammability requirements component failure testing Power Analyzer V A W High Wattage Variable Resistor OO 52 5 2 FAILURE OF THERMOSTA TS T31 Disable thermostat worst case Temperatures recorded Thermocouples Temperature Meter O 52 5 5 IMPAIRMENT OF COOLING T32 Impair each type of cooling one at a time Cooling fan disabled Ventilation blocked Temperatures lt 1 7 x temp limits minus 17 5 C Thermo couples Temperature Meter O 52 5 6 LOCKING OF MOVING PARTS TEST T33 30 seconds kept on by hand 5 minutes attended equipment Thermal Stability unattended equipment Temperatures lt Table XII Thermocouples Temperature Meter O 52 5 7 INTERRUPTION AND SHORT CIRCUI
28. age IEC 60601 1 with National Deviations mec MEDICAL ELECTRICAL EQUIPMENT Electrical equipment provided with not more than one connection to a particular supply mains and intended to diagnose treat or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and or transfers energy to or from the patient and or detects such energy transfer to or from the patient Some Definitions Patient Living being person or animal undergoing medical investigation or treatment Applied Part Any pieces of the equipment that can intentionally or unintentionally be brought in contact with the patient Creepage Spacing along a surface as an ant crawls Clearance Spacing through the air as a bug flies LOP Level of protection 2 required not defined in standard Basic Insulation Bl Spacing or a physical insulation barrier providing 1 LOP Supplemental Insulation Sl Spacing or a physical insulation barrier providing 1 LOP Double Insulation DI BI SI and provides 2 LOP Reinforced Insulation Rl Single spacing or physical insulation barrier that provides 2 LOP Protective Impedance Component such as a resistor that provides 1 LOP Protective Earth PE Well grounded part that provides 1 LOP Class Equipment Equipment using PE as 1 LOP Class I Equipment also known as Double Insulated Equipment not using PE as 1 LOP SIP SOP Signal Input Part Signal Output Pa
29. and bands are provided with guides to prevent them from running off or from jumping out of their guiding devices Guides or other safeguards are removable only with a tool Dangerous movements of equipment parts which may cause physical injury to the patient are possible only by the continuous activation by the operator Dangerous movements of equipment parts which may cause physical injury to the patient or operator are possible only by the continuous activation by the operator Parts of equipment subject to mechanical wear are accessible for inspection Means provided for emergency switching of an electrically produced mechanical movement which could cause a safety hazard The means for emergency switching is readily identifiable and accessible and does not introduce a further safety hazard Devices for emergency stopping able to break the full load current of the relevant circuit taking into account possible stalled motor currents Means for stopping of movements operate as a result of one single action Emergency off switch has red actuator Emergency off switch once actuated maintains the equipment in off condition until action different from that used to actuate is performed Emergency off switch is readily accessible to operator Emergency off switch is marked with word STOP or symbol 5110 of IEC 878 in compliance with U S Clause 6 Emergency off switch separate and independent of the intended movement control SURFACES CORNERS
30. anufacturing process to ensure that production will not contain voids Vacuum encapsulation processes with thermosetting materials such as epoxy typically provide an acceptable construction Poured encapsulation processes with thermoplastic materials such as RTV Silicon typically do not Reference Voltage U for Creepage distances and air clearances for insulation with either side isolated floating All transformer secondary voltages lt 25 V The highest voltage of either side of the insulation All others Arithmetic sum of the highest voltages of each side PWB with gt 0 4 mm thickness is sufficient for RI requirements Values compliance with at least the values of Table XVI Creepage distances for slot insulation of motors at least 50 of the specified values For Voltages gt 1000 V apply requirements from applicable or similar IEC 60601 2 xx standard or use IEC 664 57 10b Minimum creepage distances and air clearances in the mains part between parts of opposite polarity not required if short circuiting does not produce a safety hazard 57 10c Creepage distances or clearances of at least 4 mm are maintained between defibrillation proof applied parts and other parts MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 4 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations PROTECTIVE EARTHING
31. ase Standard MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 29 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations 28 2a PP 28 2a i EQUIPMENT fitted with an anticrash device or have suspension cables duplicated and Australia independently anchored 28 2a ii Motorized drives designed to prevent the driven part from becoming hazardous inthe event of Australia a power failure 28 2a iii Carriages brakes and supports designed such that any single failure will not constitute a Australia hazard to the PATIENT 28 2a 5 F Australia a iv Effective means incorporated to prevent carriages running off supporting rails eee Po v Effective means incorporated to facilitate adequate inspection of cables and anchorages Dea i Proximity or pr ri itches may b d to minimize hazards Australia vi Proximity or pressure switches may be used to vii Ceiling supported EQUIPMENT or parts thereof connected by electrical supply cables Australia provided with stops e g for limitation of rotation or linear movement to restrict movement in a manner which avoids any undue strain on the wiring temination or damage to the wiring 28 2b as Australia LF Floor and floor to ceiling supported including mobile EQUIPMENT ee i Anticrash devices fitted to cable chains etc Australia 28 2b m i
32. ault Condition Could Occur a Interruption of protective earth conductor b Interruption of one supply conductor c Appearance of an external voltage on an F Type applied part d Appearance of an external voltage on SIP SOPs e Leakage of Flammable Anesthetic Oxygen Nitrous Oxide containers or connectors f Failure of an electrical components one at a time g Failure of mechanical parts without required safety factor h Failure of temperature limiting devices Shorting of basic or supplemental insulation Overload of mains supply transformers Interruption and short circuit of motor capacitors Locking of moving parts Impairment of cooling fans vents blocked Conditions not evaluated Unlikely to Occur Total breakdown of double or reinforced insulation Loss of protective earth on permanently installed equipment More than one Single Fault Condition at a time Failure of a UL Recognized optocoupler barrier Failure of a UL Recognized Y1 capacitor acting as a barrier 3 100 1a Printed wiring boards comply with U S National or internationally harmonized component USA standards unless they are connected totally in a SELV circuit limited to 15 W or less maximum available power and whose failure will not result in a Safety Hazard USA 1 o Lithium batteries comply with U S National or internationally harmonized component standards 3 100 1 Optical isolators comply with U S National or interna
33. cal description D foe aik 8 Type of protection against electric shock Class 1 Class Il Internally Powered Equipment Degree of protection against electric shock Type B BF CF Applied Parts Degree of protection against the ingress of water IP_____ Ordinary D D foe foe i aik Methods of sterilization or disinfection D D foe foe e pee 8 1 Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Or Category AP APG Equipment 8 1 D 6 Mode of operation if not continuous Specified Period loading cycling Markings specified in Sub clause 6 1 included in the accompanying documents if they have not been permanently affixed to equipment See also 6 8 3 D foe ats Warning statements and the explanation of warning symbols provided in the accompanying documents Insert the following sub clause after the last paragraph Language of accompanying documents Korea shall be included in Korean D foe a 6 8 2a 6 8 2a 6 8 2a the sequence of operation the connection and disconnection of detachable parts and accessories the replacement of material which is consumed during operation information regarding potential electromagnetic or other interference and advice regarding avoidance 6 8 2a General information provided in instructions for use state the function and intended applicati
34. ce of protective earth connections other than in Cl 18 f exceeds 0 1 Ohm the allowable value of the enclosure leakage current is not exceeded in single fault condition Functional earth terminal not used to provide protective earthing Class II equipment with isolated internal screens insulation of screens and all internal wiring connected to them is double insulation or reinforced insulation functional earth terminal clearly marked 18l explanation of functional earth terminal provided in the accompanying documents 18m USA Earthing of X ray equipment All parts operating at over 600 V ac 850 V dc or 850 V peak are enclosed in protectively earthed enclosures Earthing of X ray equipment Connections from high voltage equipment to other high voltage USA components made with high voltage shielded cables 18n Accessible non current carrying conducti ve parts are protectively earthed or may be Double USA Insulated 18 Note If PWB traces are used for Protective Earthing the traces must pass the UL1950 PAG UL No 2 5 1 002 test CSA C22 2 No 0 4 M1982 Sub clause 4 3 per table 5 Ee pm CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS O Hen a Enclosure and earth leakage currents comply with U S limits a a ce a a eT ee Pd a ee a ee C ee ee il a e So o E E i E Booo E o o o o o m m C g o g o gl 2 g 19 1b patient leakage current 19 16 patient auxiliary
35. ch are not protectively earthed Supplementary insulation between hand held flexible shafts and motor shafts Class l Separation method of accessible parts other than applied parts from live parts 1 basic insulation accessible part earthed 2 by protectively earthed conductive part e g screen 3 by separate earthed intermediate circuit limiting leakage current to enclosure in event of insulation failure 4 by double or reinforced insulation 5 by protective impedances limiting current to accessible part Additional leakage current test in single fault conditions Arrangements used to isolate defibrillation proof applied parts so designed that no hazardous electrical energies appear during a discharge of a cardiac defibrillator after exposure to the defibrillation voltage the equipment continues to perform its intended function Distances between conductive parts within a layer of a multi layer PWB are subjected to the additional performance requirements 2 9 7 of UL 1950 60950 may be considered solid insulation and may be permitted to comply with the Distance Through Insulation requirements of minimum 0 4 mm for reinforced insulation Thermal cycling is not required for R C printed wiring consisting of prepeg cured with epoxy resin and used at temperatures not exceeding 90 C Distances between conductive parts within flexible PWB s such as multi layer polyamide or Mylar should be considered uncemented joints
36. cords are marked green yellow at the ends of the additional conductors Medical Gas Cylinders and Connections Replace the existing text of Item a with the following a Identification of the content of gas cylinders used in medical practice as part of electrical EQUIPMENT shall be in accordance with AS 1944 see also sub clause 56 3a In accordance with ISO ISO R 32 Identification of the content of gas cylinders in accordance with the color coding requirement of ANSI NFPAQ9 Identification of connection point US and Canada have CONFLICTING color coding of gas hoses must have separate models for each country Indicator Lights and Push Buttons action MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 20 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations ACCOMPANYING DOCUMENTS Cord connected equipment provided with instructions to indicate type of attachment plug for alternate voltage Equipment accompanied by documents containing at least instructions for use Equipment accompanied by documents containing at least a technical description Equipment accompanied by documents containing at least an address to which the user can refer JSA o gt orm tat op x Paes gt D foe a Classifications specified in Clause 5 included in both the instructions for use and the techni
37. cription All characteristics essential for safe operation provided Markings used from Clause 6 1 Manufacturer Name Model Voltage Range Type of Current AC DC Frequency Power Input Watts Amps VA Aux Mains Output Power if provided Mode of operation if not continuous Type amp Ratings of External Fuses Ratings of External Outputs Special cooling requirements Limited Mechanical Stability Protective Packing Requirements Unpacking Safety Hazards Sterile Equipment amp Accessories Marked Sterile Required type and rating of fuses utilized in the mains supply circuit external to permanently installed equipment Instructions for replacement of interchangeable and or detachable parts which are subject to deterioration during normal use Instructions or reference information for repair of equipment parts designated by the manufacturer as repairable provided 6 8 3d 6 8 UL Environmental conditions for transport and storage specified in accompanying documents and marked on packaging Ranges must stay within the following to avoid additional testing Temperature range within 40 C to 70 C Relative humidity range within 10 to 100 atmospheric pressure range within 500 to 1060 hPa lie Medical Equipment With Respect to Electric Shock Fire and Mechanical Hazards Only C US inAccordance with UL 60601 1 CANICSA C22 2 No 601 1 and XXXX IEC 60601 1 Additional Collaterals IE
38. d minimum V flame rating mm thick Rated A Provided in Line and Neutral IEC 60601 1 with National Deviations QMRX2 QMJU2 NRNT2 UL U U ZMVV2 U n U U UL U L L L L L L L QQGQ2 UL PIDF2 QQHM2 k D FOKY FOKY2 CENELE Cc E a QMFZ2_ UL JDYX U JDYX2 CENELE JDYX JDYX2 FHXT IZLT2 JAMZ2 NWGQ2 UL 2601 1 IEC 60601 IEC 60950 IEC 60335 IEC 60950 UL 1283 IEC 60384 14 UL 60950 IEC 60950 UL 248 IEC 60127 UL 248 IEC 60127 UL 198G UL 512 IEC 60127 6 UL 60950 IEC 60950 Compiled by Brian R Biersach 8 60601 Clause Checklist Rev 33 05 2005 Heating Elements Insulator Interconnect cable External ELV SELV TNV Interconnect cable External hazardous voltage Keyboard Laser Module Monitor LCD Motor Construction Only Motor Impedance Protected Motor Start Capacitor Optical isolator MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Medical Evaluation Package IEC 60601 1 with National Deviations B D k B AVLV2 U ZJCZ E a D B NWGQZ2 PIDF PIDF2 B T CYWT UL CYWT2 B a Rated _____ kV dielectric minimum FPQU2 U with at least mm between pins on opposite sides of chip U U U U U U U U U L L L L L L L L L L L L L IEC 60227 IEC 60245 IEC 60950 UL 969 UL 60950 CDRH I
39. e for Reinforced Insulation provided it is suitable for the application Insulating material shall be unaffected by aging 0 no hygroscopic materials or natural rubber simultaneously Mains power cord plug used to isolate equipment if no mains switch Means for isolation incorporated in equipment or if external specified in the accompanying documents Equipment provides means to isolate its circuits electrically from the supply mains on all poles 57 1d Switches used to comply with Sub clause 57 1a comply with the creepage distances and air clearances as specified in IEC Publication 328 57 1f Po Mains switches not incorporated in a power supply cord 57 41h a Appliance couplers and flexible cords with mains plugs provide compliance with Sub clause 57 1a a pszim ff Fuses and semiconductor devices not used as isolating devices 2 572 ia USA Power cord mains plug is Hospital Grade type 57 2 Grounding reliability marking provided on Equipment or on a tag attached to the supply cord USA grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade 4 Po Plug for radiography equipment acceptable for current not less than 50 of maximum input ie a Plug acceptable for use with current not less than 125 of rated current USA Po Plug acceptable for voltage for which the equipment is configured when shipped 57 2 Polarized plug wir
40. e power supply cord unlikely to become detached accidentally ojo ofo ee ofo ofo ele ele ee EE Pe ee RE A BE BE ololisa BE gg olol ofo mja ofo ma ofo pg ofo ofo folo ee aa ce 0fo ofolofol clo ofo BJo ol o of of of of of of of of of of of of fol ofo O MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 38 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Mains terminal devices and wiring of mains part not applicable for IEC 320 detachable cord sets Mains connected equipment other than those with a detachable supply cord provided with mains terminals where connections are made with screws nuts or equally effective methods If a conductor breaks away barriers are provided such that creepage distances and air clearances cannot be reduced Screws and nuts which clamp external conductors not serve to fix any other component Terminals closely grouped with any protective earth terminal Mains terminal devices accessible only with use of a tool Mains terminal devices located or shielded that should a wire of a stranded conductor escape when the conductors are fitted there is no risk of accidental contact If leads are provided for connection to branch circuit the free end is in separate compartment If leads are provided for connection to branch circuit the free length
41. east 4 mm are maintained between defibrillation proof applied parts and other parts US DEVIATIONS FOR OXYGEN At least one of the following three requirements is satisfied Electrical components separated by barrier per 400 2 400 1 2 USA Compartments with electrical components ventilated per 400 3 400 1 3 f ee USA Electrical components comply with 400 4 so that cannot be a source of ignition ofo m Po Barrier required by 400 1 is sealed at all joints and holes 60 Canada 0 400 USA 400 1 6 Canada 400 1 1 USA Ventilation required by 400 1 is such that oxygen content does not exceed 4 above ambient Under N C and S F C the product of the value of no load rms voltage and short circuit rms current less than 10 VA Surface temperature of components below 300 C in N C and S F C External exhaust gas outlets located at least 20 cm from any electrical component mounted on the outside Hospital beds intended for use with oxygen administering equipment provided with required markings Pendant controls on hospital beds with oxygen administering equipment marked as required Instructions for installation are in compliance with requirements of this clause US DEVIATIONS FOR SEPARATE POWER UNITS PACKED WITH EQUIPMENT Separate power units provided with correlation marking Direct plugin unit construction and performance comply with required sections of UL1310 Direct plugin unit external temperature rise during o
42. ed such that the center contact of Edison base lamp holder single pole switch USA or single pole overcurrent device connected in ungrounded side 57 2a Replace not used with Supply plugs Provision for inspection Where a supply flexible cord is Australia fitted with a rewirable plug of a type complying with the requirements of AS 3112 for 3 pin plugs the plug clear backed to facilitate inspection of the cord colors and the condition of the terminations 57 2e Auxiliary mains socket outlets on non permanently installed equipment of a type that cannot accept a mains plug 57 2e Permanently installed equipment may be considered as an extension of the building wiring even SI UL though it can have PE resistance up to 0 1 ohms Products connected to the auxiliary mains socket outlet of the permanently installed equipment can have up to 0 2 ohms PE resistance 57 20 Unless functional earth needs to be provided Class appliance inlet is not used in Class II equipment 57 20 Canada Le Po if molded on type hospital grade complying with CSA C22 2 No 21 eo Mains plug of non permanent installed equipment eae hospital grade disassembly type complying with CSA C22 2 No 42 57 2g Canada if Class Il equipment polarized hospital grade CSA configuration 1 15P MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 37 60601 Clause Checklist Rev
43. edical gas connections on EQUIPMENT Australia shall if operating at positive pressures greater than 50 kPa in NORMAL USE comply with AS 2472 AS 2473 or AS 2896 as appropriate Medical gas inlet connectors 56 3a Canada 3 a 56 3a pe Canada 56 3a Canada are DISS type complying with CGA V 5 are configured to permit the supply from assemblies complying with CAN CSA 2305 2 Connector pin plug attached to patient connected lead or contact cannot engage any part on the equipment including separable cord set Connector pin plug attached to patient connected lead or contact cannot make contact with live parts of power receptacle outlet if product can be used without professional supervision Accessible metal parts can not become live when detachable interconnection cord between different parts of equipment is loosened or broken Leads with conductive connection to a patient are constructed such that no conductive connection remote from the patient can contact earth or hazardous voltages 56 3a Canada are non interchangeable 56 3a Canada MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 34 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations a e gt nS i Connections of Capacitors Not connected between live parts and non protectively earthed accessible parts
44. elain vitreous windings Class 120 Operator accessibe continuously hed surfaces ubberwood 75 Windings Class F O 155 Operator accessible surfaces held for short time metal Windings Class H 180 Operator accessible surfaces held for short time porcelain vitreous Rubber PVC insulation of wiring cords with T marking Other op accessible parts except lamps heaters guards handles 35 Parts that may have brief contact with the Patient in normal uss 50 Parts in contact with oil having flash point fp p25 Applied parts not intended to supply heat to a Patient From Subclause 42 3 41 TABLE Xb MAXIMUM ALLOWABLE TEMPERATURES At 25 C Ambient Appliance Inlets hot conditions 185 Moldings of urea formaldehyde o Appliance Inlets other conditions o f Polyesterwithglass fiber reinforcement ss _Al terminals for external conductors Poltetratluorethylene o Oo Adjacent to Switches amp Thermostats without T marking 55 Pure mica and tightly sintered ceramics used as RIorSI 4 Flexible cords if flexing is likely to occur 60 Used as thermal insulation and in contact with hot metal Laminates bonded with Melamine phenol formaldehyde resins 200 Natural rubber used for safety when used as RI or S CT 60 Laminates bonded with phenol furfuralresins 200 Natural rubber used for safety in other cases CordsheathsusedasSI_ Cd Moldings o
45. etailsare available from KTL c o KTL on request MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 44 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations TABLE IV LEAKAGE AND PATIENT AUXILIARY CURRENT LIMITS in mA Type of Leakage Auxiliary Current EARTH Class Equipment EARTH All likely accessible surfaces non conductive EARTH Class II Equipment functional earth EARTH All likely accessible surfaces non conductive EARTH Permanently Installed Equip EARTH No PE accessible Mobile X ray equipment ENCLOSURE PATIENT ac PATIENT dc PATIENT Mains on SIP SOP PATIENT Mains on Applied Part SIP SOPs grounded PATIENT AUXILIARY CURRENT ac PATIENT AUXILIARY CURRENT dc US Deviation L C limits the highest voltage ratings 120 amp 240 V may be used instead of the 90 110 of voltage rating z OJ TABLE V DIELECTRIC WITHSTAND TEST VOLTAGES in Volts a aT TABLE XVI CREEPAGE amp CLEARANCE REQUIREMENTS in millimeters Voltage DC Voltage AC BOP Creepage 0 8 0 4 Clearance L837 so 1 0 0 5 BITSI Grespage 17 20 n ao n Clearance 08 DI7RI Creepage 3 4 PG Clearance C e 105 Operator accesstbe contnuously heldsurlaces veta 1 Windings ClassB C130 Operator accessible continuously held surfaces porc
46. f 25 V on one side of the transformer do not need to be summed as stated in 20 3 Dielectric breakdown between primary and secondary through earth is not considered a failure eg Switching P S Components crossing the barrier may be tested individually or the shorting earthed part may be modified as to not interfere with the dielectric test MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 27 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations MECHANICAL STRENGTH Sufficient rigidity of an enclosure tested by force of 45 N Sufficient strength of an enclosure tested by impact hammer The impact hammer test may be waived when the ball impact test is performed on the same test locations 5 ft lbs Ball impact 6 78 j impact energy gt 0 5 j impact energy from impact hammer 0 5 j 0 3688 ft Ibs 4 425 in lbs UL Ball Drop Test 13 5 Times the Energy of the Impact Hammer When risk of injury can occur end stops are provided End stops have mechanical strength as determined by the test Moving parts of a transportable equipment are provided with guards which form an integral part of the equipment Moving parts of a stationary equipment are provided with similar guards as above unless it is evident that equivalent protection is separately provided during installation Cords ropes chains
47. f phenol formaldehyde with cellulose fillers 20 _Impregnated or varnished textile paper press board no wires 95 Moldings of phenol formaldehyde with mineralfillers 225 Laminated bonded with phenolfurfuralresins TH Laminated bonded with urea formaldehyderesins 90 f Woodingeneral O Z CC CSNCOCOCOC drSCON CO d Moldings of phenol formaldehyde with cellulose fillers 110 Electrolytic Capacitors without te marking S Moldings of phenol formaldehyde with mineral filers 125 Other Capacitors without te marking O o Z o o o Moldings of melamine formaldehyde 100 f Supports Walls Ceiling Flooroftestcorner TABLE XIX TABLE XX oC O TEC 127 241 lt 4A TEC 127 30 min IEC 241 60 min TEC 127 241 gt 4 10A__ 19 IEC127 30 min IEC 241 60 min IEC 127 241 gt 25 A PG IEC127 30 min IEC 241 60 min Max Temp C Protection acts gt 1 hr E C Se a Po a 20 Pt a ee MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach A 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package LEC 60601 1 with National Deviations Minimum Gaps to Avoid Crush Pinch Points Requirements for Medical Electrical Equipment Covered by IEC 60601 1 From EN 394 Safety of machinery Minimum gaps to avoid crushing of parts of the human body 1993 Crushing Zone Zone in which the
48. human body or parts of the human body are exposed to a crushing pinching hazard This hazard will be generated if two movable parts are moving towards one another one movable part is moving towards a fixed Part Methodology a Identify the crushing hazards b Assess the risks from these hazards Head least 1300 c From table select the appropriate minimum gap favourable relating to the body part at risk position d If adequate safety cannot be achieved by the minimum gaps selected from the table other or additional measures and or means shall be used Leg Note A crushing zone is considered only for powered movements or where weight or momentum may generate sufficient force to generate a crushing pinching hazard The possibility of access to a crushing zone for a particular part of the body is dependent on the following The gap between the parts the depth of the crushing zone the dimensions c of the opening in the protective structure and its distance d from the crushing zone Tom 0 394in 1 m 39 4 in 1in 2 54cm 1ft 30 48 cm 10 tilt Distance One Side Lifted Width of Base 0 173648 F C x 1 8 32 C F 1 8 32 1 N 0 225 Ib 1 kg 2 2 Ib 1 g 0 0022 Ib 1 m sec 2 237 mph 1 Nm 141 6 in oz 0 7376 ft los 8 851 in lbs 11 33 80z 200 ml 6 76 oz 11 61 in 1kPa 0 145 psi 50 kPa 7 25 psi 1 psi 6 895 kPa MECA Medical Equipment Complia
49. ine component requirements UL Recognition Electrical Mechanical Flame Ratings etc Verify corrected noncompliances from Preliminary Evaluation as applicable Conduct full construction evaluation to standard requirements review specifications and certificates for critical components Conduct Initial Review with Underwriters Laboratories Construction documentation and test plan Perform required testing at MECA s UL witness testing facility or UL when required Verify label marking requirements Verify accompanying document requirements Review Biocompatibility on patient contact parts as applicable sie s biocompatibility information acceptable ISO 10993 1 Software evaluation IEC60601 1 4 ISO IEC12207 ANSI UL1998 2 Edition Required if mitigating fire shock or mechanical hazards in N C Ne S F C or if required by applicable particular standard s Take photographs of equipment for report 1200 x 1600 pixels minimum Create critical component list including all components needed to pass tests and meet the requirements of the standard Write UL Informative Test Report CB Style for UL C UL for US and Canada Classification Final review with Underwriters Laboratories UL Issue Authorization to apply the UL Mark and provides UL Report Q EMC testing Optional in US for UL Mark required for Europe by the MDD IEC60601 1 2 Q CB Report Optional Required only for obtaining other Safety Marks VDE TUV NEMK
50. ipment contain a liquid reservoir T21 O the equipment is electrically safe after 15 overfill steadily over a period of 1 min T21 44 2 transportable equipment is electrically safe after additionally having been tilted through an angle of 15 in the least favorable direction s if necessary with refilling ma 44 3 Electrical properties of the equipment do not change in connection of spillage test 200 ml of water T23 44 4 Liquid which might escape in a single fault condition does not wet parts which may cause a safety hazard T24 l Equipment sufficiently protected against the effects of humidity T25 44 6 Enclosures designed to give a protection against harmful ingress of water classified according to IEC Publication 529 T26 Equipment capable of withstanding cleaning sterilization or disinfection without deterioration of 0 MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 31 safety provisions 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations A a a ay a 5 pa D Aj gt A Aj gt A ca AY A AY A A oa gt o oj j s oa a gt w M y N o PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE Pressure vessel with pressure volume greater than 200 kPa x and pressure greater than 50 kPa withstand the hydraulic test pressure iN Maximum pressure does not exceed
51. ircuit parts marked as required in Sub clause 15c e w Marking of Controls and Instruments Mains switch clearly identified ON and OFF positions marked according to Symbols 15 and 16 of table D1 or indicated by an adjacent indicator light Table DI 15 16 IEC Symbol IEC Symbol Indication of different positions of control devices and switches Table DI 17 18 o w D Indication of the direction in which the magnitude of the function changes or an indicating device if change of settings could cause a hazard D D D w w w O leg D The functions of operator controls and indicators are identified Numeric indications of parameters are in SI units except for units listed in Am 2 Ethernet Connectors marked not for phone connection or pass 1 kV Dielectric test between connectors and enclosure other secondary circuits Symbols Used symbols comply with Appendix D or IEC 417 and or IEC 878 or ISO publications if applicable D w g o 9 ee v amp T o iz MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 19 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Colors of the Insulation of Conductors Protective earth conductor has green yellow insulation at least at their terminations terminations Additional protective earthing in multi conductor
52. l 12 03 MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach C
53. load just below temperature of thermal cut out increased slowly or Current Time from Table XX Thermocouples Temp Meter Amp Meter High Wattage Rheostat o 57 9 2 TRANSFORMER DIELECTRIC STRENGTH T49 NOT Testing Barrier see Clause 20 All Mains Transformers lt 500 V Except in switch mode power supplies Humidity preconditioning 5 x Voltage amp 5 x Frequency for 1 min may be induced by secondary Variable Frequency Voltage Power supply O 59 2 BALL PRESSURE TEST T50 Not required for UL Classification on polymeric materials with rated RTI value of gt 75 Using Apparatus in Fig 48 for 1 hour lt 2 mm impression Enclosures 75 C Mains parts 125 C Air Circulating Oven Ball Pressure Apparatus MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 5 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 6 60601 Clause Checklist Rev 33 05 2005 Adhesive Appliance Inlet Outlet Appliance Inlet with Filter wi Fuse Holder Battery Lithium Battery Standard Lead Acid Battery Pack Battery Charger Non Medical Bridge Rectifier Bushing Capacitor X Type Y Type Y1 Double Insulated Capacitor General CD ROM D
54. mers where DI required 1 mm thick minimum is required Evaluate areas where potting does not contribute to separation and where bonding may affect how spacings are measured Conformal Coating used on PWB considered to contribute 1 mm each to creepage distances for specific applications Exit of the wires of toroidal transformers provided with double sleeving complying with requirements for double insulation and having total thickness at least 0 3 mm extending at least 20 mm outside the winding 57 9 4a Po one bobbin with insulating partiton MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 40 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Creepage distances and air clearances Products or constructions using insulating compounds encapsulation to provide DI shall comply with Sub Clause 2 9 7 of UL 1950 60950 Except that 1 The minimum DTI for DI shall be 1 mm UL 1950 Sub Clause 2 9 4 1 3rd and 4th dashes This is to keep the requirements in line with those in Sub Clause 57 9 4 e 1st dash 2 The Humidity Conditioning test shall be performed per Sub Clause 4 10 and 3 The Dielectric Strength test shall be performed per Clause 20 Note 1 UL 1950 60950 Practical Application Guidelines for this Sub Clause can be used as appropriate Note 2 Special attention is expected for the m
55. nce Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach B 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Medical Standards Updated May 1 2005 IEC 60601 1 Ed 2 12 98 Medical Electrical Equipment 27 Electrocardiographic Monitoring Equipment 04 94 Ed 2 Project AAMI EC 13 331 IEC 601 1 1988 Am 1 11 91 Am 2 03 95 Ed 3 will be published near end of 2005 28 X ray Source Assemblies and X ray Tube Assemblies for Medical Diagnosis 03 93 29 Radiotherapy Stimulators 04 93 Am 1 11 96 Consolidated Ed 2 01 99 National Deviations USA UL 60601 1 Ed 1 4 25 2003 30 Automatic Cycling Indirect Blood Pressure Monitoring Equipment 03 95 Ed 2 12 99 AAMI SP 10 331 EU EN 60601 1 8 1990 Am 1 5 1993 Am 2 6 1995 Am 11 5 1993 Am 12 5 1993 Am 13 1 1996 Canada CSA C22 2 No 601 1 M90 11 2003 31 Extemal Cardiac Pacemakers with Internal Power Source 10 94 Am 1 01 98 Japan JSA JIS T0601 1 12 27 1999 a 32 Associated Equipment of X ray Equipment 03 94 IEC 60601 1 xx 33 Magnetic Resonance Equipment for Medical Diagnosis 07 95 Ed 2 05 02 Am 1 Project 1 Safety Requirements for Medical Electrical Systems 06 92 Am 1 11 95 Ed 2 12 00 a Arey AE are MENE OU clca JE eCUcal SYSTEM 00 22 MaMa Aca Leo 34 Direct Blood Pressure Monitoring Equipment 12 94 Ed 2 10 00
56. no safety hazards 52 5 3 Short circuiting of either part of double insulation presents no safety hazard T32 52 5 5 Impairment of cooling temperatures not exceeding 1 7 times the values of Clause 42 minus 17 5 C T33 52 5 6 Locking of moving parts presents no safety hazard T34 52 5 7 Interruption and short circuiting of motor capacitors presents no safety hazard T33 52 5 8 Duration of motors locked rotor test in compliance with CI 52 5 8 525 8 Australia 2 5 9 Table XII In second row first dash after if impedance protected add maximum value Failure of one component at a time presents no safety hazard ol 2 5 10 Overload of heating elements presents no safety hazard 2 5 108 Motors intended to be remotely controlled automatically controlled or liable to be operated continuously provided with running overload protection EER of ol of ojolo folojolo olojo ojoje olol ol ol a o ol ol Rl 2 5 10h Equipment with three phase motors can safely operate with one phase disconnected ENVIRONMENTAL TESTS Not Used See Sub clause 4 10 and Clause 10 GENERAL No Requirements 55 USA US DEVIATIONS FOR POLYMERIC ENCLOSURES ol oa USA Polymeric enclosures and external combustible surfaces ol oa Polymeric enclosures comply with Conductive coatings applied to nonmetallic surfaces comply with UL 746C USA ol oa External combustible surface of more than 9 47 m2 or single dimension
57. of 3 7 m have flame USA spread rating not exceeding 75 Steiner Tunnel Test 55 USA External combustible surface of more than 4 74 m2 but not exceeding 9 47 m2 have flame spread rating not exceeding 75 Radiant Panel or Steiner Tunnel Test 55 USA Polymeric enclosures for transportable equipment rated 94V 2 or better for circuits with gt 15 W available power ol oa USA Polymeric enclosures for fixed or stationary equipment rated 94V 0 or better maa 55 ry USA Polymeric enclosures withstand 6 78 Nm 5 ft lbs impact test UL Ball Impact T42 55 l i USA Polymeric enclosures no deformation after mold stress test for molded parts T13 55 f f f USA Polymeric enclosures of hand held equipment withstands 1 22 m drop test see Clause 21 5 ojoj ma mm o c n a a a O a a a O of O of oo MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 33 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Conductors and connectors secured and or insulated to prevent accidental detachment resulting in a safety hazard Connectors provide separation required by Sub clause 17g Plugs for connection of patient circuit leads can not be connected to other outlets on the same equipment Medical gas connections not interchangeable Replace the text in the third dash by the following M
58. of leads inside field wiring compartment is at least 152 mm long Internal wiring not subjected to stress when the means for clamping the conductors are tightened or loosened This waives the fuse requirement of Clause 57 6 for products with the following features characteristics Separable power supply battery charger Direct Plugin or Desktop type Linear transformer isolated Rated 120 V only With Nameplate and Maximum output ratings less than 100 W Provided with double insulation between parts of opposite polarity and Provided with double insulation between mains parts and any parts connected to ground Fuses or over current releases must have means of opening at a specific current thermal cutoffs PTCs not acceptable Current rating of mains fuses and over current releases such that they reliably carry the normal operating current Individual conductor in the mains part with insulation not at least electrically equivalent to that of the individual conductors of flexible supply cords complying with IEC Publications 227 or 245 treated as bare conductor Cross sectional area of conductors up to protective device not less than the minimum required for the power supply cord Cross sectional area of other wiring and the sizes of tracks on printed wiring circuits sufficient to prevent any fire hazard MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian
59. on of the equipment include an explanation of the function of controls displays and signals 6 8 2a 6 8 2a 6 8 2a 8 2a include indications of recognized accessories detachable parts and materials if the use of other parts or materials can degrade minimum safety D D D foe foe to ay 6 foe i w instructions concerning cleaning preventive inspection and maintenance to be performed including the frequency of such maintenance General information provided in instructions information for the safe performance or routine maintenance 6 8 2a 6 8 2a including the periods to be applied 6 8 2d 6 8 2e Warning statement for mains operated equipment with additional power source A warning to remove primary batteries if equipment is not likely to be used for some time Instructions to ensure safe use and adequate maintenance of rechargeable batteries 6 8 2 6 8 2g D N w MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 21 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Identification of specified external power supplies or battery chargers necessary to ensure compliance with the requirements of IEC 601 1 s Identification of any risks associated with the disposal of waste products residues etc s Advice i n minimizing these risks Technical des
60. ons ojojoj rerema 6 1q attention consult accompanying documents Table DI 14 nonionizing radiation or symbols as adopted by ISO or IEC 417 Anesthetic proof symbol AP or APG Table DI 4 5 Dangerous voltage symbol Table DI 6 HIGH VOLTAGE TERMINAL DEVICES on the outside of EQUIPMENT which are accessible without the use of a TOOL shall be marked with the symbol dangerous voltage see Appendix D Table DII Symbol 6 and wit the Korean language Special cooling requirements Limited mechanical stability Protective packing requirement s Marking s for unpacking safety hazard s Equipment or accessories supplied sterile marked as sterile Potential equalization terminal Table DI 7 Functional earth terminal Table DI 9 Removable protective means marked to indicate necessity for replacement Medical Equipment With Respect to Electric Shock Fire and Mechanical Hazards Only In Accordance with UL 60601 1 CANICSA C22 2 No 601 1 and IEC 60601 1 UL 60601 1 IEC 60601 1 CAN CSA 22 2 No 601 1 Additional Collaterals IEC 60601 1 X and or Particulars IEC 60601 2 XX as necessary Durability of marking test Distilled water Denatured Alcohol Methylated Spirits Isopropyl Alcohol O a O g g O o O o oO K g C MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 18 60601 Clause Checklist Rev
61. orrect connection without the use of tool E ol ie ie M E o E E A ol E E E ol E E o ol ol g 5 E o ol 2 o ol o E 56 10c Stops are provided on rotating controls 56 10c to prevent an unexpected change from maximum to minimum or vice versa where this could produce a safety hazard oloje tree sae wing MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 35 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Cord connected hand held and foot operated control devices Contain voltages not exceeding 25 V a c or 60 V d c and isolated from the mains part by Cl 17g Higher voltages attained by stepping up through an inverter are allowable if leakage current and dielectric withstand tests are performed and if spacings are met for the higher voltage Hand held control devices comply with the requirement and test of Sub clause 21 5 MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 36 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations MAINS PARTS COMPONENTS AND LAYOUT 5 Permanently connected equipment provided with field wiring provision in accordance with NEC USA ANSI NFPA 70 74 7 Outside of transformers a thickness of 0 4 mm is acceptabl
62. pment markings they should appear in French and English a All words in CAUTION WARNING and DANGER markings at least 1 6 mm 1 16 high MEPS n gt b Signal words CAUTION WARNING and DANGER at least 2 8 mm 7 64 n gt c Letters in contrast color to the background n gt Equipment capable of emitting ionizing radiation provided with warning statement If equipment produced in more than one factory factory identification marked on the equipment n gt Multiple voltage equipment intended for permanent connection marked with voltage for which it is connected when shipped eo eo lee e D gt SA z e gt Marking on the Outside of Equipment or Equipment Parts Markings of the specific power supply affixed If marking is not practicable due to size or nature of enclosure information is included in accompanying documents Table DI 14 D D o an a k oO Qa fo Name and or trademark of the manufacturer or supplier lt D Model or type reference 6 1g Rated supply voltages or voltage range s 6 1g Number of phases if not single 6 1g Type of current AC or DC Table DI 1 2 3 4 5 Ny KAV why a Ny Insert the following between the first and second dashes For low voltage equipment rated at 200 V or more a voltage rating which may be part of a range of not less than 230 V Supply frequency ratings which include 60 Hz must also include 50
63. r removed Exceptions Plug in modules Covers of illuminated push buttons Covers of indicator lamps Covers over recorder pens Covers of battery compartments empty lamp holders specified not to open in the patient s vicinity a n ak n ak ak i ak e2 D e2 D D D e2 e2 D oO oO oO Qa O O O o a e2 oO Exception 16e applied to the following parts Openings for the adjustment of controls using a tool The tool not able to touch basic insulation or any live parts 5l E g l i E ol 2 g ol lo g E E a li E oj o ofololo o olo olojo o qo lo o o o oclololo o ofo ofojo oO doj olojaf e gt MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 24 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations SEPARATION Separation method of the applied part from live parts 1 basic insulation applied part earthed 2 by protectively earthed conductive part e g screen 3 by separate earthed intermediate circuit limiting leakage current to applied part in event of insulation failure 4 by double or reinforced insulation 5 by protective impedances limiting current to applied part Additional leakage current test in single fault conditions There is no conductive connection between applied parts and accessible conductive parts whi
64. rive Circuit Breaker Supplementary protector Circuit Breaker Accessories Circuit Breaker Adjustable Trip Circuit Breaker GFCl Computer MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Medical Evaluation Package Securing to IEC 60601 1 with National Deviations MAGW2 Rated Rated Rated Protected by BBCV2 rated____ max charging current or current limiting component R C NWGQ2 V A minimum V A minimum V and Rated V approximately Rated V approximately FOKY2 AYVZ2 BAZR2 BBFS QQQX2 QQFU2 NZMT2 FOWX2 CYWT2 NWGQ2 QVNU QVNU2 DIHS2 DKPU2 DKUY2 NWGQ UL 498 IEC 60309 1 IEC 60309 2 IEC 60320 1 IEC 60320 2 2 UL1642 UL2054 IEC 60384 14 UL 60950 IEC 60950 UL 1077 IEC 60934 Compiled by Brian R Biersach 7 60601 Clause Checklist Rev 33 05 2005 Conductive Coating Conformal Coating Crimp Connectors DC DC Converter Enclosure Polymeric Enclosure Filter EMI RFI Floppy disk drive Fuse Mains Fuse DC Fuse holder Hard disk drive MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Medical Evaluation Package Crimped on closedjoop or spade connectors for securing under screw terminals or quick disconnect type connectors with positive detent Overall cm by cm by cm mm thick Rate
65. rt RS232 USB Ethernet port Phone jack ITE Information Technology IEC 60950 Equipment eg Computer Monitor Printer N C Normal Condition S F C Single Fault Condition Insulation Diagram Graphic illustration of the electrical isolation not defined in standard Data Port SIP SOP Requirements Reference to the accompanying documents or full specifications of connected equipment to be marked on or near the SIP SOP connection s IEC 60950 ITE connection Considered 50Vdc in N C and Mains 240 V in S F C Phone line connection Considered 120Vac ringing voltage in N C and S F C MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 13 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Equipment when transported stored installed operated in normal use and maintained according to the instructions of the manufacturer causes no safety hazard which could reasonably be foreseen and which is not connected with its intended application in normal condition N C and in single fault condition S F C An ee ee eee means of construction is used to that detailed in this standard and it can be demonstrated that an ee ee eee degree of safety is obtained Normal Condition Likely to Occur Reverse polarity of supply mains Failure of insulation less than basic operational Single F
66. s in the Range 1 MeV to 50 MeV Ed 2 06 98 Am 1 05 02 43 X ray Equipment for Interventional Procedures 06 00 2 High Frequency Surgical Equipment Ed 3 09 98 Ed 4 Project AAMI HF 18 331 44 X ray Equipme nt for Computed Tomography 02 99 Ed 2 06 01 Am 1 09 02 Ed 2 1 11 02 SH Shoes E a Tels 22 UGE Aa CIEE aoe Pasa 45 Mammographic X ray Equipment and Mammographic Stereotactic Devices 09 98 Ed 2 05 01 4 Cardiac Defibrillators and Cardiac DefibrillatorM onitors 01 83 Ed 2 08 02 Corr 1 04 04 AAMI DF 2 331 46 Operating Tables 06 98 5 Ultrasonic Therapy Equipment 01 84 Ed 2 07 00 47 Ambulatory Electrocardiographic Monitors Holter Monitors 07 01 6 Microwave Therapy Equipment 01 84 48 Canceled 7 High Voltage Generators of Diagnostic X ray Generators Ed 2 02 98 49 Multiparameter Patient Monitoring Equipment 07 01 8 Therapeutic X ray Equipment Operating in the Range 10 kV to 1 MV 04 87 Am 1 08 97 50 Infant phototherapy equipment 07 00 Corrigendum 1 03 01 Ed 1 1 Consolidated 04 99 atient Contact Dosimeters used in Radiotherapy with Electrically Connected Radiation Detectors Ed 2 10 96 0 Nerve and Muscle Stimulators 12 87 Am 1 09 01 Corrigendum 02 02 3 Anesthetic Machines Ed 2 05 98 Ed 3 05 03 Am 1 Project z 7 Remote Controlled Automatically Driven Gamma ray Afterloading Equipment 09 89 Am 1 03 96 Ed 2 01 04 looi
67. the bed itself X RADIATION EQUIPMENT not intended to produce X radiation produces an exposure lt 130 nC kg 0 5 mR MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 30 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations oe oO Alpha BETA GAMMA NEUTRON RADIATION No Requirements in Base Standard MICROWAVE RADIATION No Requirements in Base Standard LIGHT RADIATION INCLUDING LASERS No Requirements in Base Standard INFRA RED RADIATION No Requirements in Base Standard ULTRAVIOLET RADIATION No Requirements in Base Standard ACOUSTICAL ENERGY INCLUDING ULTRA SONICS No Requirements in Base Standard ELECTROMAGNETIC COMPATIBILITY Equipment complies with IEC 601 1 2 Ed 2 2001 COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG EQUIPMENT Requirements for category AP and APG equipment Cl 37 41 For equipment used in the presence of Oxygen see US Cl 400 MARKING ACCOMPANYING DOCUMENTS CATEGORY AP amp APG EQUIPMENT Kk oa o COMMON REQUIREMENTS FOR CATEGORY AP amp APG EQUIPMENT REQUIREMENTS AND TESTS FOR CATEGORY AP EQUIPMENT O OO O O OOR foo a e a ofpjolal REQUIREMENTS AND TESTS FOR CATEGORY APG EQUIPMENT EXCESSIVE TEMPERATURES A gt BY ojl wj wo j j j fj WwW w NI O ej feel NEN o O Oo A oF N A N
68. the maximum permissible working pressure for individual parts Unless excessive pressure can not occur pressure relief device provided a Pressure relief device connected as close as possible to the pressure vessel b Readily accessible for inspection c Not capable of being adjusted or rendered inoperative without a tool d Discharge opening located that the released material is not directed towards person e Discharge opening located that operation will not deposit material which may cause a safety hazard f Adequate discharge capacity to ensure pressure does not exceed the maximum permissible working pressure g No shut off valve between a pressure relief device and the parts intended to be protected h Minimum number of cycles of operation 100 000 HUMAN ERROR Not Used ELECTROSTATIC CHARGES Not Used BIOCOMPATIBILITY Parts of equipment and accessories intended to come into contact with biological tissues cells or body fluids are evaluated in accordance with ISO 10993 1 or biocompatibility data from supplier of material in Applied Part INTERRUPTION OF THE POWER SUPPLY Thermal cut outs and over current releases with automatic resetting not used if they may cause a safety hazard Interruption and restoration of power supply does not result in a safety hazard other than interruption of intended function Means are provided for removal of mechanical constraints on patient in case of a supply mains failure ACCURACY OF OPER
69. tionally harmonized component standards USA unless they are connected totally in a SELV circuit limited to 15 W or less maximum available power and whose failure will not result in a Safety Hazard 3 100 1d Wiring and tubing comply with U S National or internationally harmonized component standards USA unless they are connected totally in a SELV circuit limited to 15 W or less maximum available power and whose failure will not result in a Safety Hazard 1g a CRT s gt 5 inches comply with U S National or internationally harmonized component standards Primary circuit components up to isolation transformer meet U S national or international harmonized component standards Primary components shall be UL recognized to a UL standard or special investigation Where required by this standard compliance with applicable IEC standards will be required This may be demonstrated by another agency s mark Other components in secondary circuits need only comply with the standards listed in App L if so referenced in the base collateral or particular standards Components that do not meet the requirements for that component are faulted per subclause 4 4 MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 14 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations GENERAL REQUIREMENTS FOR TESTS Only Ins
70. uipment up to 4kVA Rated voltage not exceeding 500 V for all other equipment Rated input frequency not more than 1kHz Rated voltage not exceeding 250 Vdc or single phase ac or 600 V polyphase ac for equipment up to 4kVA Rated voltage not exceeding 600 V for all other equipment Internal replaceable electrical power source specified NOT USED NOT USED GENERAL Risk of Electric Shock in Normal Use and in Single Fault Condition Shall be reduced as far as Reasonably Practicable REQUIREMENTS RELATED TO CLASSIFICATION Fixed equipment and permanent equipment is Class Class and Class II equipment in addition to basic insulation provided with an additional protection Equipment supplied from external dc source of reverse polarity results in no safety hazard Dual classification for internally powered equipment with a means of connection to supply mains Internally powered equipment complies with requirements for Class or Class Il equipment while connected to supply mains and with requirements for internally powered equipment when not connected Applied parts intended for direct cardiac application are of type CF Class II Equipment with a grounded plug Accompanying Documents shall clearly indicate no Protective Earthing is provided MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 23 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation
71. ulation Components and Constructional Features which could produce a Safety Hazard in Normal and Single Fault Conditions shall be tested Tests shall not be repeated unless otherwise specified in this standard Tests are made on representative samples of the equipment Equipment that is to be connected to the mains isintended for one of the permitted voltages and frequencies a Nominal frequency of 50 Hz 4 7a Israel 4 7a Israel 4 7a Israel 4 7a Israel 4 7b Israel 4 7b Israel 4 7b Israel Of a Po b Nominal voltage of 230 V for portable and hand held equipment MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 15 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Classification according to the degree of protection against ingress of water as detailed inthe current edition of IEC 529 see 6 1 1 aj ala ee 8 a eee On n wm wmf gt a to 2 to Or OE OP On Or Say Se Or a Gy ojl Dm a of aj a a gt a D MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 16 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations IDENTIFICATION MARKING AND DOCUMENTS Where written safety warnings appear as equi
72. urrents gt allowable values if SIP SOP component failure c SIP SOPs not protectively earthed or separated from accessible parts d SIP SOP parts not tested with equipment and specified in manual Dielectric strength for applied parts per TABLE V Conducted At operating temperatures After humidity preconditioning After sterilization disinfection B a DI Between live parts and applied parts patient circuit B b Between different parts see particular standard if applicable B c SI Between applied parts and parts not protectively earthed and separated from live parts by BI B d BI Between F type applied part and earth enclosure SIP SOPs B e DI Between F type applied part with stressing voltages in normal conditions and enclosure Barriers specified in 20 1 and 20 2 are examples and are not necessarily the only required in the equipment Any barrier that is required to mitigate a hazard leakage current auxiliary current hazardous movement etc is a required barrier F type applied parts separation from ground does not include the operator who may be earthed Lead insulation is required where leads may contact earth or earthed parts not counting patient or operator Reference Voltage U Voltage that the insulation is subject to in normal use at maximum rated voltage For insulation with either side isolated floating U is the sum of the highest voltages of each side Barriers with a maximum voltage o
73. verheating test do not exceed 65 C If direct plug in unit provided with a mounting tab unit marked as required by UL1310 400 4 USA 400 4 USA 400 5 USA 400 6 USA 400 7 USA 400 8 USA 600 1 USA 600 1 USA 600 2 1 USA 600 2 2 USA 600 2 3 USA 400 3 USA MECA Medical Equipment Compliance Associates LLC Download at http 60601 1 com documents htm Compiled by Brian R Biersach 43 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations General National Deviations General Deviations Genera Denmark Genera Denmark Genera Denmark Genera Korea Genera Korea Genera Korea Genera Korea For plug and socket outlets the National Standard SB 107 2 D1 3rd Edition applies For Class equipment Plugs DK 2 la DK 2 la with flat phase pin or DK 2 5a Socket outlets DK 1 3a a For Class II equipment Plugs DKA 24a DKA 2 1b Clb C5 C6 or according to EN 50075 oes National supply voltages are 110 V 220 V and 380 V Only appliances having supply frequency of 60 Hz or a frequency range including 60 Hz are accepted Instruction manuals and appliance markings related to safety including nameplate shall be in Korean or graphical symbols in accordance with IEC Publication 417 Plugs for connection of the equipment to the supply mains shall comply with the Korean Standard KSC 8305 and 8300 More d
74. y Brian R Biersach 4 60601 Clause Checklist Rev 33 05 2005 Medical Evaluation Package IEC 60601 1 with National Deviations Test CLAUSE TEST O 55 US MOLD STRESS RELIEF TEST T42 For polymeric enclosures and covers only Highest 70 C or Maximum temp 10 C for 7 hours Air Circulating Oven O 56 7 REVERSED BATTERY CONNECTION T43 No damage to battery or safety of equipment waived if mechanically polarized to make connection correctly Thermocouples Temperature Meter 0 56 10b ACTUATING PARTS OF CONTROLS T44 56 10c For knobs gt 10 mm diameter 2 sec force in each direction alternately 10 times See table XII for torque Torque Meter 0 56 11b CORD CONNECTED FOOT SWITCH MECHANICAL STRENGTH T45 56 11d 1350 N for 1 min IP X7 required in wet surgical areas Force Meter O 57 4a STRAIN RELIEF T46 Conductors cut Pull 25 times 1 second each Then Torque for 1 min lt 1 kg 30 N Pull 0 1 Nm Torque 1 4 kg 60 N Pull 0 25 Nm Torque gt 4 kg 100 N Pull 0 35 Nm Torque Force Torque Meter 1 kg 2 2 Ib 1 N 0 225 Ib 1 m 39 4 in Oo 57 4b CORD GUARD FLEXING T47 Curvature gt 1 5 Diameter with weight 10 x Diameter g hanging perpendicular or 5000 cycle flex test 180 with gt 90 total conductor strands not broken Weight Cylinder of 1 5 x Diameter of cord 1 g 0 0022 Ib 57 9 1 TRANSFORMER OVERHEATING TEST Each secondary short circuited and overload Over

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