96B391E8
Contents
1. O 03 5805 6131 OO OO O OOOOO OO OO OOOO2. Jis JIS T 2003 2 25pt 1 A B 2 OOx O Ox OO mm OOKg 3 1 AC100V 50 60Hz 2 OOW 4
3. JI S J I S JIS J 1 S IEC60335 2 27 JIS 17 25 JIS T 2001 1 H12 3 20 JIS J60335 2 2 7 IEC60335 2 32 IEC60335 2 60 mowoceoacDpgD
4. Ng gt JIS T 2002 JIS T 2005 J JIS T 2004 I S JIS T 2003 Q 06G OO JIS T 2006 0 JIS T 2008 JIST2010 sr JISC9335 2 32 H12 3 20 JIS 1 J60335 2 32 J60335 2 60 J60335 2 J7 JISC9335 2 209 JISC9335 2 60 H12 9 20 JIS 1 JISC9335 2 207 H12 3 20 JIS 1 JISC9335 2 209 1 JISC9335 2 JISC9335 2 210 JISC9335 2 211
5. Body Onces arein Class I if they are intended for transient use are in Class la if they are intended for short term use except if they are used in the oral cavity as far as the pharynx in an ear canal up to the ear drum or in a nasal cavity in which case they are in Class I IIa are in Class IIb if they are intended for long term use except if they are used in the oral cavity as far as the pharynx in an ear canal up to the ear drum or in a nasal cavity and are not hable to be absorbed by the mucous membrane in which case they are in Class Ha IIb IIa AH invasive devices with respect to body orifices other than surgically invasive devices intended for connection to an active medical device in Class IIa or a higher class are in Cl
6. 2 3 4 5 6
7. 1 5 Active therapeutic device Any active medical device whether used alone or in combination with other medical devices to support modify replace or restore biological fanctions or structures with a view to treatment or alleviation of an iHness injury or handicap 1 6 Active device for diagnosis Any active medica1 device whether used alone or in combination with other medica1 devices to supply information for detecting diagnosing monitoring or treating physiological conditions states of health illnesses or congenita1 deformities 1 7 Central circulatory system For the purposes of this Directive central circulatory system means the following Vessels arteriae pulmonales aorta ascendens arteriae coronariae arteria carotis communis arteria carotis externa arteria carotis interna arteri
8. Q 1 D 2 3 4 38 1 2 5 6 7 8 9 MS T 2003 1 1 2
9. Jis 1 mA 2 V 3 OO sec 4 OOH z 1 2 1 2 3 4 5 6 7 3 Jis JiS
10. 1 2 2 N IO lo WM JIS 1 2 3 4
11. II 3 Additional rules applicable to active deviceg 3 1 Eule 9 9 Al active therapeutic devices intended to administer or exchange energy are in Class lia unless their characteristics ae such that they may administer or exchange energy to or from the human body in a potentially hazardous way taking account of the nature the density and site of applhcation of the energy in which case they are in Class Iib IIa IIb All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb or intended directly to influence the performance of such devices are in Class tb IIb IIb 3 2 Rule 10 10 Active devices intended for diagnosis are in Class ITa
12. IIa if they may be connected to an active medical device in Class Ifa or a higher class Ia if they are intended for use for storing or channeling blood or other body hquids or for storing organs Darts of organs or body tissues in al other cases they are im Class L 1 1 3 Rule 3 3 Al non invasive devices intended for modifying the biologicat or chemical composition of blood other body hquids or other 1iquids intended for infusion into the body are in Class Ifb unless the treatment consists of filtration centrifugation or exchanges of gas heat in which case they are in Class IIa ITb s IIa 1 4 Rule 4 4 Al non invasive devices which come into contact with injured skin
13. 3 4 5 DO 6 7 2 1 2 3
14. 4 5 1 2 3 4 3 5 6 7 4 1
15. IIa if they are intended to supply energy which will be absorbed by the human body except for devices used to illuminate the patient s body in the visible spectrum if they are intended to image in vivo distribution of radio pharmaceuticals if they are intended to allow direct diagnosis or monitoring of vital physiologrcal processes unless they are specificaly intended for monitoring of wital physiological parameters where the nature of variatiorts is such that could result in rmmediate danger to the patient for instance variations in cardiac performance YesDiYation activity of CNS in which case they are in Class IIb IIb Active devices intended to emit ionizing radiation and intended for diagnostic and therapeu
16. are in Class I if they are intended to be used as a mechanical barrier for compression or for absorption of exudates are ln Class IIb they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent nt secondary intenD IIb Secondary intent Primary intent are in Class Ia in al other cases including devices principally intended to manage the micro environment of a wound ITa 2 Invasive devices 2 1 Rule 5 5 Alt invasive devces with respect to body orifices other than surgically invasive devices and which are not intended for connection to an active medical device
17. C lt MDD IX gt ANNEX TX CLASSIFICATION CRITERIA 1 DEFINITIONS 1 Definitions for the classification rules 1 1 Duration Transient Normally intended for continuous use for less than 60 minutes 60 Short term Normally intended for continuous use for not more than 30 days 30 Long term Normally intended for continuous use for more than 80 days 80 1 2 Invasive devices Invasive device A device which in whole or in part penetrates inside the body either through a body orifice or through the surface of the body Body orifice Any natural opening in the body as weH as the external surface of the eyeball or any permanent artificial opening such as a stoma SurgicaHy invasive device An invasive device which penetrates inside the body through the surface of the
18. 2 4 Ifthe device is not intended to be used solely or principally in a specific part of the body it must be considered and classified on the basis of the most critical specified use 2 5 If several rules apply to the same device based on the performance specified for the device by the manufacturer the strictest rules resulting in the higher classification shall apply TII CLASSIFICATION 1 Non invagive deviceg 1 1 Rule 1 1 All non invasive devices are in Class I unless one of the rules set out hereinafter applies I 1 2 Rule 2 2 All non inyasive devices intended for channehng or storing blood body liquids or tissues hquids or gases for the purpose of eventual infusion administration or introducion into the body are in Class IIa
19. II or to undergo chemical change in the body except if the devices are placed in the teeth ox to administer medicines in which case they are in Class JIb IIb 2 4 Rule 8 8 AH implantable devices and Jong term surgncally invasive devices are in Class Iib unless they are intended IIb to be placed in the teeth in which case they are in Class Ia IIa to be used in direct contact with the heart the central circulatory system or the central nervous system in which case they are in Class III III to have a biologncal effect or to be wholly or mainly absorbed in which case they are in Class IL III or to undergo chemical change in the body except the devices are placed in the teeth or to agdmninister medicines in which case they are in Ciass III
20. 1 3 Reusable surgical instrument Tnstrument intended for surgical use by cutting drilhing sawing scratching scraping Clamping retracting clipping or similar Drocedures without connection to any active medical device and which can be reused after appropriate procedures have been carried out 22 972 1 4 Active medical device Any medical device operation of which depends on a source of electrical energy or any Source of power other than that directly generated by the human body or gravity and which acts by converting this energy Medical devices intended to transmit energy Substances or other elements between an active medical device and the patient without any significant cbange are not considered to be active medical devices
21. JISC9335 2 211 1 JISC9335 2 212 JISC9335 2 212 1 Spbt OOOO OO CO 2 OOOO OOOOB 1 2 2 OOOOOOOO 78 JMDN 70986000 8pt 2 25pt 2 25pt 1
22. body with the aid or in the context of a surgical operation For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an estabhshed body orifce shall be treated as surgicaHy invasive devices 1mplantable device Any device which is intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye by surgical untervention which is intended to remain in Place after the procedure Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device 30
23. 5 293 1 JTS T XXX CHy Srr 88 JISC933S 1 J 85 JISC9335 2 XXX 293 1 1 1 SO1348 JIS O 14971 J SS014 1 J SS001 0213001 HS JTS C J IS JIS T JIS JI S
24. ae cerebrales truncus brachicephalicus venae cordis venae pulmonales vena cava superior vena cava inferior 1 8 Central nervous system CNS For the purposes of this Directive central nervous system means brain meninges and spinal cord I IMPLEMENTING RULES 2 Implementing rules 2 1 Apphcaton of the classification rules shall be governed by the intended purpose of the devices 2 2 If the device is intended to be used in combination with another device the classification rules shall appiy separately to each of the devices Accessories are classified in their own right separately from the device with which they are used 2 3 Software which drives a device or influences the use of a device falls automatically in the same class
25. ass iIa Ia IIa 2 2 Rule 6 6 Al surgically invasrve devices intended for transient use are in Ciass IIa unless they are ITa intended specifically to diagnose monitor or correct a defect of the heart or of the central ciculatory system through djrect contact with these parts of tbe body in which case they are in Class III II reusable suygical instruments in which case they are in Class J 1 intended to supply energy in the form of ionizing radiation in which case they are in Class IIb IIb intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb TIb intended to administer medicines by means of a delivery system if this is
26. done in a manner that is potentially hazardous taking account of the mode of application in which they are in Class IIb IIb 2 3 Rule 7 7 All surgically inyasive devices intended for short term use are in Class ITa unless they are intended ITa either specifically to agnose monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body in which case they are in Class IIL III or specifically for use in direct contact with the central nervous system in which case they are in Class JI III or to supply energy in the form of ionizing radiation in which case they are in Class Iib Tb or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III
27. inal product as defined in Article 1 of Directive 65 65 EEC and which is hable to act on the human body with action ancillary to that of the devices are in Class III 65 65 1 HIT 2 Rule 14 Al devices used for contracepton or the prevention of the transmission of sexually ransmitted seases are in Class IIb unless they are implantable or 1ong term invasive devices in which case they are in Class Hl 1iifb 1IT 3 Rule 15 Ai devices intended specifically to be used for disinfecting cleaning rinsing or when appropziate hydrating contact lenses are in Class IID HHb AH devices intended specifically to be used for disinfecting medical devices are in Class IIa IIa This rule does not apply to products that are intended to clean medical devices other
28. than contact 1enses by means of physical action 4 Rule 16 Non active devices specifically intended for recording of X ray diagnostic images are in Class IIa X IIa 5 Rule 17 All devices manufactured utiizing animal tssues or derivatives rendered non viable are Class II except where such dewces are intended to come into contact with intact skn only IH 5 Rule 18 By derogation from other rules blood bags are in Class IIb HIb 2005 OS 183 5 JIS T 2003 EE lt 1 IEC 6033S 1 IEC 60601 1 JIS T 0601 1 EC 60601 2 3 EC 60601 2 10 8
29. tic interventional radiology including devices which control or monitor such devices or which directly influence their performmance aye in Class Hfb IIb Rule 11 11 All active devices intended to administer and or remove medieines body liguids or other substances to or from the body are in Class IIa unless this is done in a manner 3 4 4 4 4 4 4 IIa that is potentially hazardous taking account of the nature of the substances involved of the part of the body concerned and of the mode of application in which case they are in Class IIb ITb 3 Rule 12 12 All other active devices are in Class 1 Special Rules 1 Rule 13 13 Al devices incorporating as an integral part a substance which if used separately can be considered to be a medic
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96B391E8