UL 2601-1, UL 60601-1, IEC
Contents
1. Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 1 of 10 Medical Equipment Compliance Associates LL Speed Your Medical Equipment to Market SERVICES TESTING DOWNLOADS ABOUT INFORMATION SEMINARS LINKS _ FAQFORUM REQUEST INFO QUOTE TABLES DIAGRAMS P BASICS INSULATION T AN INTRODUCTION TO CERTIFICATION AND REGULATORY REQUIREMENTS The following information is provided to help you with your design and safety evaluation decisions Links within page Intro US amp Canada Requirements European Requirements Medical Electrical Safety Standards Basic Requirements of UL 2601 1 IEC 60601 1 Evaluation of Medical Equipment The Documentation Process Common Noncompliances Download the Original Article in PDF Format Designing Medical Electrical Equipment to Meet Safety Certification and Regulatory Requirements Note On April 25 2003 UL issued UL 60601 1 to replace UL 2601 1 There are no requirement differences between UL 60601 1 and UL 2601 1 format changes only Medical equipment is highly regulated and held to a higher level of safety than nearly all other types of equipment on the market The main reasons for this are that medical equipment may be used on patients 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http ww2. 4 of 7 3 3 2006 2 34 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm The following are actual Insulation Diagrams created for products As you can see they illustrate the required barriers for each device as in the examples You will also notice that the format tables and information provided vary between them This is simply because there is no formal format and every engineer has a little different way that he or she creates them It simply needs to illustrate the required barriers and other electrical protection in the simplest way The rest depends on the artistic capability of the engineer and the time they have to create it 220 240 Volts 110 120 Volts T HE sos 20mm t amp mm 35mm 35mm N HB m As 30mm 18 Sam 4m 10K m m 5 of 7 3 3 2006 2 34 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm Plastic Enclosure 5 antrais 100 120 s 220 240 t Le Ay sor wo ss 1 ie WA 4 25 gt 26 154v HO so seo sso sony HD wr 29 so seo 40v o wa Nw NA 25 m 2 m pum 16720 25 40 gt 40 25 40
3. supplemental Insulation SI is also a spacing or a physical insulation barrier providing 1 LOP Double Insulation DI is BI SI and provides 2 LOP Note that BI BI does not result in DI Reinforced Insulation RI is a single spacing or physical insulation barrier that provides 2 LOP Protective Impedance is a component such as a resistor that provides 1 LOP Protective Earth PE is a well grounded part that provides 1 LOP Class I Equipment uses PE as 1 LOP Class II Equipment also known as Double Insulated does not use PE as an LOP For electrical safety the standard requires 2 LOP against excessive unintentional current defined as leakage current passing through the patient or operator The following illustrate the above terms and the requirement for 2 LOP Insulation Diagram Class Equipment Bl PE 2 LOP 3 3 2006 2 34 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm Insulation Diagrams Continued Class Il Equipment DI or RI 2 LOP Plastic Enclosure 2 of 7 3 3 2006 2 34 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm Insulation Diagrams Continued Class or Equipment DI or RI 2 LOP Note Enclosure is Not PE Metal Enclosure Function al Earth For the following examples the specifications in red on the right are the options f
4. 15790 mr hm p uu oum qo xo PATIENT Applied Par SIP SOPS grounded _______ __ ___ __ ___ _ 58 ____ _____ 6 PATIEHT AUXLIART CURRENT __ gt _ 05 05 O AUMLIARY CURRENT de ___ O05 0d __ _____500 KC L J ck __ 3Kk 4K Zi2V 1 5K IV 2 5K Creepage Hiaarance Clearance 1 ndings Claes A 105 parator acres 6 continuously hald suras metals Windings Class 8 Operator accessible coninuoust hald surfaces windings Class E Operator accessible coninuoust held surfaces rubber ood w ndings Clas Operator surfaces held metab w ndlrgs Class Operator surfaces held Tor ehottime parcelairivrirenus Adjacent io Ewihes E Thermostats wih T marang Motor Cape with masimum operating Temperature armed He Anplied par noi intended 10 supple heat lo a Patent TE From Subiclauag 42 3 TABLE L9 DAppiameiiis gerdWom Pmestre hdessfberrmbyamen 398 Adlacentto Switches Thermostats whan marng 75s Puremweasrdightysimemdzsmm s uesdasRIGre as Fliabi e tetom OO O Used es Insdenon ana r contact with anu
5. authorizes the manufacturer to apply the UL C UL US Canada Mark to products covered in the report It describes the equipment evaluated and its critical components UL conducts quarterly audits using this report to verify that the equipment bearing the UL C UL Mark is the same as the equipment that was tested An Informative Test Report is a complete documentation of all the requirements in a standard N A Pass or Fail a test record insulation diagram illustrations equipment markings and other applicable information It is the preferred document for MDD technical files required for CE marking and required by some international hospitals and clinics for equipment purchases A CB report or National Certification Body report is similar to an Informative Test Report but also contains a certificate from the issuer who is required to be a member of the IECEE CB Scheme A CB report is used to obtain certification marks in different countries without repeating the full evaluation of the equipment The Informative Test Report or CB Report are very important to have for the equipment s technical files and act as an international passports for a device COMMON NONCOMPLIANCES There are many common noncompliances that could have been easily avoided had the designers been aware of the safety standard requirements early in the design phase The most common noncompliance item relates to the accompanying documents the 601 standards have very spec
6. effectiveness Class I devices are subject to premarket notification registration and listing prohibitions against adulteration and misbranding and rules for good manufacturing practices Class II devices also need performance standards and Class III devices need premarket approval from the FDA A 510 k is a collection of documents and forms used to show substantial equivalence to a device that was either in commercial distribution before May 28 1976 or has been reclassified into Class I or I 1 The FDA or accredited Third Party Reviewer examines the documentation and determines whether the device 15 substantially equivalent to the specified predicate device or not If the device 1s found to be substantially equivalent it can be marketed and sold in the US If the device is not found to be substantially equivalent due to new technology or differences in intended use then the submitter must present information such as clinical trial data statistical data and safety testing results to the FDA to show that the device 15 safe and effective If the FDA finds the information and data adequate they will grant premarket approval for the device The FDA Federal Food Drug and Cosmetic Act requires that all medical devices be safe and effective and recognizes safety standards as a means to support a declaration of conformity Many Authorities Having Jurisdiction AHJ and purchasers of medical electrical equipment in the US and Canada require a safet
7. steps for a typical evaluation of medical electrical equipment Review the information previously identified 8 of 10 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 9 of 10 Evaluate construction of equipment Perform required testing Electrical Mechanical Temperature Abnormal Condition Testing etc Software evaluation IEC60601 1 4 ISO IECI2207 ANSI UL1998 2nd Edition Required if mitigating fire shock mechanical hazards or requirements of particular standard s Electromagnetic Compatibility EMC testing optional for UL Classification Per collateral standard IEC6060 1 1 2 Review of biocompatibility documentation on patient contact parts optional for UL Classification Per ISO 10993 1 standard Develop critical component list If it affects test results or requirements in the standard it s a critical component May be design specifications spacings colors etc Prepare the technical report and optionally the Informative Test Report Preferred document for CE Marking technical files THE PROCESS OF DOCUMENTATION The documentation developed as a result of a safety evaluation depends on the manufacturer s requirements The three common types of documentation are a UL report an Informative Test Report and a Certified Body CB report A UL report consisting of a product description and test report
8. 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm _ __ 60601 2 2 High Frequency Surgical Equipment 60601 2 38 Electrically Operated Hospital Beds 60601 2 Many Others Particular Standards Figure 2 Organization of the IEC60601 1 Standard IEC60601 1 REQUIREMENTS Philosophy The underlying philosophy of the IEC60601 1 harmonized standards is that equipment must be safe in normal condition NC and single fault condition SFC To understand the electrical safety requirements we need to first define a few terms An Applied Part is any pieces of the equipment that can intentionally or unintentionally be brought in contact with the patient Creepage 1s spacing along a surface as an ant crawls Clearance is spacing through the air as a bug flies LOP 15 a level of protection 2 required by standard Basic Insulation BI 1s a spacing or a physical insulation barrier providing 1 LOP Supplemental Insulation SI 1s also a spacing or a physical insulation barrier providing 1 LOP Double Insulation DI is BI SI and provides 2 Reinforced Insulation RI is a single spacing or physical insulation barrier that provides 2 LOP Protective Impedance is a component such as a resistor that provides 1 LOP Protective Earth PE is a well grounded part that provides 1 LOP Class I Equipment is defined as
9. 25 15 6017 3 3 2006 2 34 Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm 100 240 Dep lay m Do Di 80mm 50mm 80mm 80mm 40 8 26v 40mm 35mm 40mm 40mm 15 40mm 28mm gt 4dmm gt 40mm 15v WA NA NA Ds NA _ M A M A TA Cana ieee IE 20mm Thrughlsulatn NOV NEN 3 Back to Top of Page 7 Medical Equipment Compliance Associates LLC 7 of 7 3 3 2006 2 34 PM MECA Information Page Tables Cheat Sheet for UL 2601 1 UL 60 http www mecassociates us tables htm ECA Medical Equipment Compliance Associates LLC Speed Your Medical Equipment to Market MAIN SERVICES TESTING DOWNLOADS ABOUT MECA CONTACT me nm ZR REQUEST INFORMATION SEMINARS LINKS FAQ FORUM INFOIOUOTE BLOG INSULATION AALS DIAGRAMS PARTICULARS BASICS 1014 3 3 2006 2 36 MECA Information Page Tables Cheat Sheet for UL 2601 1 UL 60 http www mecassociates us tables htm TABLE VALUES AND TEST LIMITS FOR IEC 60601 1 UL 2601 1 EN 60601 1 amp CSA C22 2 No 601 1 All Amendment changes and US Deviations have been integrated in these tables CLOSURE PATIENT 0 __ 0 9 amp 1 95 05 PATIENT cys oi AT
10. ARDS Product Safety certification agencies use safety standards to evaluate many different types of products These safety standards are consensus documents which define the minimum construction and performance requirements Table 1 provides an example of UL Standards that cover medical and related product categories A complete list of UL standards covering more than 5 000 product categories can be found at http ulstandardsinfonet ul com UL 187 X Ray Equipment withdrawn end of 2010 product freeze at end of 2004 UL 198 Fuses UL 498 Appliance Inlets UL 544 Medical and Dental Equipment withdrawn end of 2010 product freeze at end of 2004 UL 1577 Optical Isolators UL 60950 1 Information Technology Equipment Computers etc UL 2111 Motors UL 2601 1 Changed to UL 60601 1 UL 60601 1 Medical Electrical Equipment UL 61010 1 Electrical Equipment for Laboratory Use Table 1 Example of UL Standards Since 1972 electrically operated medical equipment used in the US has been evaluated to the UL544 Standard for Medical and Dental Equipment This standard will be withdrawn at the end of 2004 requiring both new and current UL544 equipment to be evaluated to the UL 2601 1 Standard to continue to apply the UL Mark Underwriters Laboratories published UL2601 1 in 1994 UL2601 1 was written as an IEC601 1 renamed IEC60601 1 harmonized standard Prior to this harmonization initiative manufacturers were required to comply with diff
11. E E Lamingtes pene furfural eem Haturalrubier uae Tar sete rrr ther cases 175 Larinsted bonded wil uree formlaehde resins Molding of phenol de with callulpza Tilers Elecholtic without 1r rearing 125 100 TABLE XIX 3i n 4n B 175 127 241 10 25 1 75 117 30 min 241 B rmin 2014 3 3 2006 2 36 MECA Information Page Tables Cheat Sheet for UL 2601 1 UL 60 http www mecassociates us tables htm 3 of 4 127 241 25A _ 48 EGEZ 30 mh 241 B rmin UL L amp ted Fuse 35 O tmn Olhars Hn from Fusa tunm OOO OOOO O 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 human body or parts of the human body are exposed to a crushing pinching hazard This hazard will be generated 1f 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 c From table select the appropriate minimum gap relating to the body part at risk d If adequate safety cannot be achieved by the minimum gaps selected from the table
12. For equipment with plastic enclosures there will also be flammability requirements for the plastic material Make sure the plastic chosen for the enclosure has at least a UL Recognized V O flame rating for fixed equipment and a UL Recognized V 2 flame rating for all other types of equipment The last typical mistake relates to indicator lights Red indicator lights can only be used for a warning yellow for caution Keep this in mind when selecting LEDs for any indicator lights These common noncompliances can be easily avoided with knowledge of the applicable standards and they are the major reasons that preliminary investigations of medical equipment are routinely done in the early design phase Back to Top of Page 15 240 Medical Equipment Compliance Associates LLC 3 3 2006 2 35 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm 1017 i Medical Equipment Compliance Associates LLC Speed Your Medical Equipment to Market TESTING DOWNLOADS ABOUT CONTACT Ca cw XY ux i ax GAs INFO QUOTE INFORMATION SEMINARS LINKS BASICS E TABLES INSULATION DIAGRAMS THE BASICS OF INSULATION DIAGRAMS An Insulation Diagram sometimes called an Isolation Diagram is a graphic illustration of the insulation barriers required by UL 2601 1 UL 60601 1 60601 1 for electrical safety The k
13. ance for equipment with a detachable power supply cord or 0 2 Ohms for equipment with a non detachable power supply cord The Canadian requirement changes the current to 30 Amps or 2 rated current and changes the time to 2 minutes Since this 1s the only major difference between the US and Canadian standards the test is typically done at 30 A for 2 minutes as the worst case for testing protective earthed parts CREEPAGE amp CLEARANCE REQUIREMENTS rin millimeters 300 750 Creepage 3 0 Clearance 1 Sl Creepage Clearance 2 5 I co RI Creepadge Clearance DIELECTRIC WITHSTAND TEST VOLTAGES rin Volts Table 2 Insulation Spacing and Dielectric Requirements excerpt from full tables To demonstrate that medical equipment is safe 1n normal and single fault condition the following conditions must be addressed when evaluating the equipment These conditions are specified in the Standard and need to be addressed when designing medical equipment and or selecting components Likely to Occur Normal Condition 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 7 of 10 Reverse polarity of supply mains Failure of insulation less than basic Could Occur Single Fault Condition Interruption of protective earth Interruption of one supply conductor Mains voltage on floating F type applied part s Mains v
14. ation evaluated to IEC standard or be part of the medical equipment evaluation Does equipment have electrical Signal Input Output Parts SIP SOPs What could be connected to the SIP SOPs Computers and other IT equipment are considered to have 50 V in Normal Condition Mains in Single Fault Condition on their data ports Create insulation diagram graphic illustration of the LOPs Determine classifications from the standard 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm Document components that cross all barriers per insulation diagram Verify creepage and clearance spacing requirements per the insulation diagram printed wiring boards transformers relays etc Examine enclosure openings IEC test finger access to live parts IEC test pin top openings to live parts Need for a tool to access any live parts Determine potential mechanical hazards pinch points sharp edges Determine potential hazards under abnormal use Document components that must meet a nationally recognized standard such as ANSI in the US Primary circuit components including wiring up to mains transformer s Lithium batteries also requires reverse charge protection circuitry CRTs gt 5 inches Printed wiring boards with gt 15 W available Wiring tubing with gt 15 W available Optical 1solators with gt 15 W available and or acti
15. erent standards for different countries This often required that multiple product models had to be designed and manufactured to meet different national standards if they were to be used in more than one country Using an internationally harmonized safety standard meant that a product could be designed and evaluated for compliance with a single standard such as UL2601 1 and also be eligible for use in many different countries Other countries that use IEC60601 1 harmonized standard include the European Union Canada Brazil Japan Korea and Australia In addition to being the base of so many harmonized standards IEC60601 1 is an FDA recognized consensus standard used to support a manufacturer s declaration of conformity Visit the FDA website to see all the FDA CDRH recognized standards at http www accessdata fda gov scripts cdrh cfdocs cfStandards search cfm The UL2001 1 safety standard contains the full text of IEC60601 1 and adds US deviations as shown in Figure 1 The US deviations contain national requirements such as those for the mains circuit National 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm Electric Code UL component requirements ANSI UL lower leakage current limits AAMI UL enclosure flame ratings UL and production line testing OSHA UL Since these deviations do not conflict with the base standard the equipment is
16. ey to a successful Insulation Diagram is to keep it simple It is not a schematic and should not show greater detail than is required to illustrate the required barriers The following are examples of the items that need to be graphically illustrated in the Insulation Diagram spacings components physical insulation protectively earthed parts parts with a good connection to earth ground and protective impedances resistors etc Some of the barriers that are required include Between mains circuit and accessible parts secondary circuits patient circuits the patient etc Between secondary circuits and accessible parts patient circuits the patient etc Between data ports SIP SOPs and secondary circuits accessible parts patient circuits the patient etc The underlying philosophy of the IEC60601 1 harmonized standards is that equipment must be safe in normal condition NC and single fault condition SFC To understand the electrical safety requirements that are used to create the insulation diagram we need to first define a few terms An Applied Part is any pieces of the equipment that can intentionally or unintentionally be brought in contact with the patient Creepage is spacing along a surface as an ant crawls Clearance is spacing through the air as a bug flies LOP is a level of protection not defined by the standard Basic Insulation BI is a spacing or a physical insulation barrier providing 1 LOP
17. ific requirements for inclusions in the accompanying documents Since most companies have separate departments that create these documents they are often not aware of the requirements The next most common and likely the most costly noncompliance is the power supply selection The best advice is to use a UL 2601 1 Recognized power supply evaluated to UL2601 1 by UL By doing this compliance with spacing leakage current and mains component requirements 15 assured Also the cost to evaluate the power supply and the required UL quarterly inspections at the power supply manufacturer is avoided Many designers begin with a non UL recognized power supply only to change to a UL recognized one when they discover the 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 10 of 10 associated costs of using a non recognized power supply or when they realize that it does not comply with the requirements When designing medical equipment it is also important to be aware that there are minimum spacing requirements for electrical barriers Inadequate spacings on circuit boards are another typical mistake An example of this is DC C converters Nearly all DC DC converters including UL recognized models do not provide the spacing or insulation barrier required by these standards Make sure you get the specifications on the spacings or barriers from input to output
18. ng as barrier per insulation diagram Conductive coating process Verify that component ratings meet the equipments ratings List enclosure materials UL 94 flame rating requirements for polymeric enclosures if there 15 gt 15 W available power in the enclosure V 2 min for mobile portable equipment V 0 min for fixed or stationary equipment Verify mains fuse requirements equipment or wall plug in power supply Class Line and neutral Class II with functional earth Line and Neutral Class Line only Permanently installed equipment Line only Verify protective earth conductors are green with yellow stripe Verify wires secured from hazardous movements Verify equipment marking requirements labels Verify accompanying document requirements Provide illustrations of equipment complete with all accessories showing critical components digital JPG files Once this information is developed the safety evaluation of the equipment can be initiated One or more samples are required depending on the equipment type and time requirements Multiple samples of components may be needed to perform destructive tests transformers relays plastic enclosures motors etc For medical equipment it may be advantageous to conduct a preliminary evaluation at the manufacturer s facilities This allows for more expedient changes to the equipment if there are construction or test related noncompliances The following are the
19. oltage on communication ports Failure of electrical components one at a time Failure of mechanical parts one at a time Failure of temperature limiting devices one at a time 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 Unlikely to Occur Not evaluated 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 Y 1 capacitor acting as a barrier EVALUATION OF MEDICAL EQUIPMENT The process of evaluating medical equipment for compliance with the requirements in UL2601 1 includes not only the equipment itself but the user s manual markings software if it mitigates a hazard biocompatibility of applied parts and electromagnetic compatibility Before submitting equipment for evaluation the following information should be developed Does equipment fit the scope of UL20601 1 Does equipment fit the scope of IEC60601 Collateral or Particular standards List all equipment functions and accessonies that can be used with the basic product Is the medical equipment connected to other equipment such as a computer or printer Any other equipment must have IEC certific
20. or the equipment Each option is a valid Insulation Diagram A BOP 240 V B 240 V C DI RI 240 V D E DI RI 25 V Insulation Diagrams Continued Class Equipment Metal amp Plastic Enclosure A 240 V 240 V C DI RI 240 V D 25 V E sl 25 V 240 V B 240 V C BI 240 V D 51 240 V DI RI 25 V Plastic 3 of 7 3 3 2006 2 34 PM Information Page Insulation Diagrams UL 2601 1 UL 60601 http www mecassociates us isodgms htm Insulation Diagrams Continued Class Equipment Metal amp Plastic Enclosure SIP SOPs IT Equipment 50 V NC Mains V SFC SIP SOP accessible by operator only SIP SSOP BOP 240 V B BI 240 V C DI RI 240 V D OP E DI RI 50 V BI 240 V A BOP 240 V 240 V C 240 V NOT ALLOWED E DI RI 50 V BI 240 V Insulation Diagrams Continued Class Equipment Metal Enclosure SIP SOPs SI E ASOP 240 V B BI 240 V C DI RI 288 V D DI RI 50 V BI 240 V E DI RI 12 V Metal Insulation Diagrams Continued Class Equipment Metal Enclosure SIP SOPs SIP S OP 240 V 240 V C DI RI 288 V D DI RI 50 V BI 240 V E DI RI 12 V Z Protective Impedance to limit auxiliary leakage current in Normal amp Single Fault Cond
21. other or additional measures and or means shall be used 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 3 3 2006 2 36 MECA Information Page Tables Cheat Sheet for UL 2601 1 UL 60 4 of 4 HELPFUL CONVERSIONS 1 0 394 1 m 39 4 in 1 in 2 54 1 ft 30 48 cm 10 degree tilt Distance One Side Lifted Width of Base 0 173648 1 8 32 1 8 32 1 N 0 225 Ibf 1 kg 2 2 Ib 1 g 0 0022 Ib 1 2 237 mph 1 Nm 141 6 in oz 0 7376 ft lbs 8 851 in Ibs 11 33 80z 200 ml 6 76 oz 11 2 61 in2 Medical Equipment Compliance Associates LLC http www mecassociates us tables htm 3 3 2006 2 36 PM
22. still in compliance with IEC60601 1 Amendment Appendixes IEC 60601 1 Clauses 60601 1 Us Dewi ations Figure 1 Structure of UL2601 1 The second edition of IEC60601 1 currently has two amendments that were published in 1991 and 1995 These amendments are additions and corrections to the base standard The standard also has collateral horizontal standards numbered 60601 1 and particular vertical standards numbered 1 60601 2 The collateral standards include requirements for specific technologies and or hazards and apply to all applicable equipment such as medical systems 1 1 EMC 1 2 radiation protection in diagnostic X ray equipment 1 3 and software 1 4 The particular standards apply to specific equipment types such as Medical Electron Accelerators 2 1 High Frequency Surgical Equipment 2 2 and hospital beds 2 38 Figure 2 illustrates the organization of the collateral and particular IEC60601 standards The US deviations amendments collateral and particular standards are used together to evaluate the medical electrical equipment They all use the same clause numbering system which allows cross referencing of the requirements and each may have amendments General Standard Collateral Standards 6060 1 1 60601 1 1 60601 1 2 60601 1 3 60601 1 4 Medical EM Radiation Software oystems Protection 60601 2 1 Medical Electron Accelerators 4 of 10 3 3
23. using PE as 1 LOP Class II Equipment also known as Double Insulated 1s defined as not using PE as 1 LOP For electrical safety the standard requires 2 LOP against excessive unintentional current defined as leakage current passing through the patient or operator Figure 3 graphically depicts the 2 LOP between the live part mains and the patient 1A and 2A and between the live part and the enclosure 1B and 2B In the case of and 2A the levels of protection are BI and SI For 1B and 2B they are BI and PE APPLIED 5 of 10 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 6 of 10 2 PART M A CURRENT 2 a Protective Earth Enclosure Patient Figure 3 Two Levels of Protection 2 LOP Table 2 provides an example of the minimum spacing requirements and dielectric hipot requirements for these barriers If the insulation does not meet both the dielectric and the spacing requirements it cannot be considered as a level of protection and can be shorted as a normal condition Note that BI and SI spacing requirements are the same however the SI dielectric values are greater than the BI values To be considered protectively earthed the grounding path of the equipment must pass 15 Amps or 1 5 rated current for 5 seconds from the protectively earthed part to the earth connection with 0 1 Ohms resist
24. w mecassociates us information htm 2 of 10 who are not able to respond to hazardous conditions or pain an actual electrical connection between the equipment and patient may exist and certain types of medical equipment function as life support the failure of which could result in the death of the patient While Engineers spend years in school and the workplace learning about how to design equipment they usually do not learn about the certification and regulatory requirements that the equipment must meet to comply with the US and international codes and laws Understanding these requirements before the design phase of the equipment will result in a reduction of product development cost faster certification turnaround and increased product safety This information is intended to increase awareness of product safety certification requirements by exploring the requirements for medical equipment both in the US and internationally We will look at the applicable safety standards and review their philosophy of safety then show the process of evaluation and documentation We will then discuss the most common noncompliances seen when evaluating medical equipment to safety standards MEDICAL EQUIPMENT FOR THE US AND CANADA FDA UL In the United States the Food and Drug Administration FDA sorts devices into three categories Class I II or III depending upon the degree of regulation necessary to provide a reasonable assurance of their safety and
25. y certification mark on the equipment Therefore a product that carries a safety certification mark will usually reach its full market potential Underwriters Laboratories Inc UL 15 the major product safety certification organization in North America Manufacturers of medical equipment submit product samples and information to UL for evaluation to applicable safety standard s and products that meet these requirements are authorized to apply the appropriate UL Mark for the US and or Canada MEDICAL EQUIPMENT FOR THE EUROPEAN UNION CE Marking but low risk non measuring non sterile medical devices used in Europe must bear the CE mark reviewed by a Notified Body CE mark with the Notified Body s identification number A Notified is a third party designated by European authorities to assess compliance with the Medical Device Directive 3 3 2006 2 35 PM Information Page Basics UL 2601 1 UL 60601 1 60601 http www mecassociates us information htm 3 of 10 93 42 EEC The Medical Device Directive is essentially the European law for medical devices This assessment by a Notified Body evaluates compliance with the Medical Device Directive requirements for safety performance suitability for intended use and risk analysis Manufacturers can choose from several conformity assessment routes most involving a quality assurance assessment of the manufacturer s facilities MEDICAL ELECTRICAL SAFETY STAND
Download Pdf Manuals
Related Search