CENELEC publications : EC Directive 93/42/EEC 1996-05-31
1. EN 60645-1:1994 CLC/BT
IEC 645-1:1992 + corrigendum Feb. 1993 IEC/TC 29
Audiometers -- Part 1: Pure-tone audiometers
Directive : 73/23/EEC;93/42/EEC
Order voucher :
dor: 1994-07-05 dav: 1994-08-11
doa: 1994-09-15 dop: 1995-03-15 dow: 1995-03-15
Note : Work examined by BTTF 79-4 - Conclusion: No revision
necessary
2. EN 60645-3:1995 CLC/BT
IEC 645-3:1994 IEC/TC 29
Audiometers -- Part 3: Auditory test signals of short duration for
audiometric and neuro-otological purposes
Directive : 73/23/EEC;93/42/EEC
Order voucher :
dor: 1994-12-06 dav: 1995-01-04
doa: 1995-03-01 dop: 1995-12-01 dow: 1995-12-01
Note : EN following parallel vote * Work examined by BTTF 79-4 -
Conclusion: No revision necessary
3. EN 60645-4:1995 CLC/BT
IEC 645-4:1994 IEC/TC 29
Audiometers -- Part 4: Equipment for extended high-frequency audiometry
Directive : 73/23/EEC;93/42/EEC
Order voucher :
dor: 1994-12-06 dav: 1995-01-25
doa: 1995-03-01 dop: 1995-12-01 dow: 1995-12-01
Note : EN following parallel vote * Work examined by BTTF 79-4 -
Conclusion: No revision necessary
4. EN 61260:1995 CLC/BT
IEC 1260:1995 IEC/TC 29
Electroacoustics - Octave-band and fractional-octave-band filters
Directive : 93/42/EEC
Order voucher :
dor: 1995-09-20 dav: 1995-10-10
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : EN following parallel vote
5. EN 46001:1993 CENCLC/TC 1
IEC/SC 62D
Quality systems - Medical devices - Particular requirements for the
application of EN 29001
Directive : 93/42/EEC
Order voucher : BC/CLC/09-89
dor: 1993-09-22 dav: 1993-10-27
doa: dop: 1994-06-30 dow: 1994-06-30
Note : CEN/CENELEC standard * Corrigendum to EN issued Apr. 1994
6. EN 46002:1993 CENCLC/TC 1
IEC/SC 62D
Quality systems - Medical devices - Particular requirements for the
application of EN 29002
Directive : 93/42/EEC
Order voucher : BC/CLC/09-89
dor: 1993-09-22 dav: 1993-10-27
doa: dop: 1994-06-30 dow: 1994-06-30
Note : CEN/CENELEC standard * Corrigendum to EN issued Apr. 1994
1
CENELEC publications : EC Directive 93/42/EEC 1996-05-31
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7. EN 61266:1995 CLC/BT
IEC 1266:1994 IEC/TC 87
Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors -
Performance requirements and methods of measurement and reporting
Directive : 93/42/EEC
Order voucher :
dor: 1995-02-15 dav: 1995-04-10
doa: 1995-05-15 dop: 1996-02-15 dow: 1996-02-15
Note : EN following parallel vote
8. EN 60601-1-1:1993 CLC/TC 62
IEC 601-1-1:1992 IEC/SC 62A
Medical electrical equipment -- Part 1: General requirements for
safety - 1. Collateral standard: Safety requirements for medical
electrical systems
Directive : 93/42/EEC
Order voucher :
dor: 1993-09-22 dav: 1993-10-08
doa: 1994-03-01 dop: 1994-09-01 dow: 1994-09-01
9. EN 60601-1-1:1993/A1:1996 CLC/TC 62
IEC 601-1-1:1992/A1:1995 IEC/SC 62A
Medical electrical equipment -- Part 1: General requirements for
safety -- 1. Collateral standard: Safety requirements for medical
electrical systems
Directive : 93/42/EEC
Order voucher :
dor: 1995-11-28 dav: 1996-01-05
doa: 1996-03-01 dop: 1996-09-01 dow: 1996-09-01
Note : EN following parallel vote
10. EN 60601-1-2:1993 CLC/TC 62
IEC 601-1-2:1993 IEC/SC 62A
Medical electrical equipment -- Part 1: General requirements for
safety - 2. Collateral standard: Electromagnetic compatibility -
Requirements and tests
Directive : 89/336/EEC;93/42/EEC
Order voucher :
dor: 1992-09-15 dav: 1993-05-25
doa: 1993-05-31 dop: 1993-11-30 dow: 1995-12-31
11. EN 60601-1:1990 CLC/TC 62
IEC 601-1:1988 IEC/SC 62A
Medical electrical equipment -- Part 1: General requirements for safety
Directive : 90/385/EEC;93/42/EEC
Order voucher : BC/CLC/09-89
dor: 1990-06-11 dav: 1990-08-09
doa: 1990-09-01 dop: 1991-01-01 dow:
Note : 68 BT decision: dow suspended * Will supersede HD 395.1 S2
when dow fixed * Corrigendum to EN issued Jul. 1994
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CENELEC publications : EC Directive 93/42/EEC 1996-05-31
---------------------------------------------
12. EN 60601-1:1990/A13:1996 CLC/TC 62
IEC/SC 62A
Amendment to subclause 6.6 of EN
Directive : 90/385/EEC;93/42/EEC
Order voucher :
dor: 1995-07-04 dav: 1996-01-17
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : SNCs for AT, CH, DE * Implementation dates changed
13. EN 60601-1:1990/A1:1993 CLC/TC 62
IEC 601-1:1988/A1:1991 IEC/SC 62A
Amendment to clauses 2, 3, 6, 7, 10, 14, 16, 19-22, 29, 37, 41, 44,
45, 52, 56, 57, 59 and annexes A, C, K, L of EN
Directive : 93/42/EEC;90/385/EEC
Order voucher : BC/CLC/09-89
dor: 1992-12-09 dav: 1993-05-14
doa: 1993-12-01 dop: 1994-06-01 dow:
Note : No dow * Corrigendum to EN/A1 issued Jul. 1994
14. EN 60601-1:1990/A2:1995 CLC/TC 62
IEC 601-1:1988/A2:1995 + corrigendum Jun. 1995 IEC/SC 62A
Medical electrical equipment -- Part 1: General requirements for safety
Directive : 93/42/EEC;90/385/EEC
Order voucher : BC/CLC/09-89
dor: 1995-03-06 dav: 1995-06-16
doa: 1995-06-01 dop: 1996-03-01 dow:
Note : EN following parallel vote * Incorporates and supersedes A11
15. EN 60601-1-3:1994 CLC/TC 62
IEC 601-1-3:1994 IEC/SC 62B
Medical electrical equipment -- Part 1: General requirements for
safety -- 3. Collateral standard: General requirements for radiation
protection in diagnostic X-ray equipment
Directive : 93/42/EEC;84/539/EEC
Order voucher : BC/CLC/93-01
dor: 1994-07-05 dav: 1994-09-14
doa: 1994-10-01 dop: 1995-07-01 dow: 1995-07-01
Note : EN following parallel vote
16. EN 60601-2-28:1993 CLC/TC 62
IEC 601-2-28:1993 IEC/SC 62B
Medical electrical equipment -- Part 2: Particular requirements for
the safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1993-03-09 dav: 1993-05-28
doa: 1993-06-01 dop: 1994-03-01 dow: 1994-03-01
Note : EN following parallel vote
17. EN 60601-2-32:1994 CLC/TC 62
IEC 601-2-32:1994 IEC/SC 62B
Medical electrical equipment -- Part 2: Particular requirements for
the safety of associated equipment of X-ray equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1994-03-08 dav: 1994-07-14
doa: 1994-06-01 dop: 1995-03-01 dow: 1995-03-01
Note : EN following parallel vote
3
CENELEC publications : EC Directive 93/42/EEC 1996-05-31
---------------------------------------------
18. EN 60601-2-33:1995 CLC/TC 62
IEC 601-2-33:1995 IEC/SC 62B
Medical electrical equipment -- Part 2: Particular requirements for
the safety of magnetic resonance equipment for medical diagnosis
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-09-20 dav: 1995-11-27
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : EN following parallel vote
19. EN 61262-7:1995 CLC/TC 62
IEC 1262-7:1995 IEC/SC 62B
Medical electrical equipment - Characteristics of electro-optical
X-ray image intensifiers -- Part 7: Determination of the modulation
transfer function
Directive : 93/42/EEC
Order voucher :
dor: 1995-09-20 dav: 1995-11-24
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : EN following parallel vote
20. EN 61267:1994 CLC/TC 62
IEC 1267:1994 IEC/SC 62B
Medical diagnostic X-ray equipment - Radiation conditions for use in
the determination of characteristics
Directive : 93/42/EEC
Order voucher :
dor: 1994-05-15 dav: 1994-11-28
doa: 1994-12-01 dop: 1995-09-01 dow: 1995-09-01
Note : EN following parallel vote
21. EN 60601-2-17:1996 CLC/TC 62
IEC 601-2-17:1989 IEC/SC 62C
Medical electrical equipment -- Part 2: Particular requirements for
the safety of remote-controlled automatically-driven gamma-ray
after-loading equipment
Directive : 93/42/EEC
Order voucher :
dor: 1996-03-05 dav: 1996-03-22
doa: 1996-09-01 dop: 1997-03-01 dow:
Note : Former HD 395.2.17 S1
22. EN 60601-2-17:1996/A1:1996 CLC/TC 62
IEC 601-2-17:1989/A1:1996 IEC/SC 62C
Medical electrical equipment -- Part 2: Particular requirements for
the safety of remote-controlled automatically-driven gamma-ray
afterloading equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1996-03-05 dav: 1996-03-22
doa: 1996-09-01 dop: 1997-03-01 dow: 1997-03-01
Note : EN following parallel vote
4
CENELEC publications : EC Directive 93/42/EEC 1996-05-31
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23. EN 60601-2-29:1995 CLC/TC 62
IEC 601-2-29:1993 IEC/SC 62C
Medical electrical equipment -- Part 2: Particular requirements for
the safety of radiotherapy simulators
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-05-15 dav: 1995-11-30
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : A-Deviation for CH
24. EN 61303:1995 CLC/TC 62
IEC 1303:1994 IEC/SC 62C
Medical electrical equipment - Radionuclide calibrators - Particular
methods for describing performance
Directive : 93/42/EEC
Order voucher :
dor: 1994-12-06 dav: 1995-01-09
doa: 1995-03-01 dop: 1995-12-01 dow: 1995-12-01
Note : EN following parallel vote
25. EN 50103:1995 CLC/TC 62
IEC/SC 62D
Guidance on the application of EN 29001 and EN 46001 and of EN 29002
and EN 46002 for the active (including active implantable) medical
device industry
Directive : 93/42/EEC
Order voucher : BC/CLC/02-89
dor: 1994-07-05 dav: 1995-06-07
doa: 1995-09-15 dop: 1995-12-15 dow: 1995-12-15
Note : prEN 61272 after parallel vote (failed) ratified in CLC as
EN 50103 and withheld in IEC
26. EN 60601-2-21:1994 CLC/TC 62
IEC 601-2-21:1994 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of infant radiant warmers
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1994-07-05 dav: 1994-08-31
doa: 1994-10-01 dop: 1995-07-01 dow: 1995-07-01
Note : EN following parallel vote
27. EN 60601-2-25:1995 CLC/TC 62
IEC 601-2-25:1993 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of electrocardiographs
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-05-15 dav: 1995-11-30
doa: 1996-01-01 dop: 1996-07-01 dow: 1996-07-01
Note : A-deviation for CH
5
CENELEC publications : EC Directive 93/42/EEC 1996-05-31
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28. EN 60601-2-26:1994 CLC/TC 62
IEC 601-2-26:1994 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of electroencephalographs
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1994-07-05 dav: 1994-08-31
doa: 1994-10-01 dop: 1995-07-01 dow: 1995-07-01
Note : EN following parallel vote
29. EN 60601-2-27:1994 CLC/TC 62
IEC 601-2-27:1994 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of electrocardiographic monitoring equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1994-07-05 dav: 1994-08-31
doa: 1994-10-01 dop: 1995-07-01 dow: 1995-07-01
Note : EN following parallel vote
30. EN 60601-2-2:1993 CLC/TC 62
IEC 601-2-2:1991 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of high frequency surgical equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1992-12-09 dav: 1993-04-22
doa: 1993-03-15 dop: 1993-09-15 dow: 1993-09-15
Note : Former HD 395.2.2 S1
31. EN 60601-2-30:1995 CLC/TC 62
IEC 601-2-30:1995 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of automatic cycling indirect blood pressure monitoring
equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-07-04 dav: 1995-07-18
doa: 1995-10-01 dop: 1996-04-01 dow: 1996-04-01
Note : EN following parallel vote
32. EN 60601-2-31:1995 CLC/TC 62
IEC 601-2-31:1994 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of external cardiac pacemakers with internal power source
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1994-12-06 dav: 1995-01-19
doa: 1995-03-01 dop: 1995-12-01 dow: 1995-12-01
Note : EN following parallel vote
6
CENELEC publications : EC Directive 93/42/EEC 1996-05-31
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33. EN 60601-2-34:1995 CLC/TC 62
IEC 601-2-34:1994 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of direct blood-pressure monitoring equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-03-06 dav: 1995-04-18
doa: 1995-06-01 dop: 1996-03-01 dow: 1996-03-01
Note : EN following parallel vote
34. EN 60601-2-3:1993 CLC/TC 62
IEC 601-2-3:1991 IEC/SC 62D
Medical electrical equipment -- Part 2: Particular requirements for
the safety of short-wave therapy equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1992-12-09 dav: 1993-04-22
doa: 1993-03-15 dop: 1993-09-15 dow: 1993-09-15
Note : Former HD 395.2.3 S1
35. EN 60601-2-22:1996 CLC/TC 76
IEC 601-2-22:1995 IEC/TC 76
Medical electrical equipment -- Part 2: Particular requirements for
the safety of diagnostic and therapeutic laser equipment
Directive : 93/42/EEC
Order voucher : BC/CLC/93-01
dor: 1995-11-28 dav: 1996-01-08
doa: 1996-03-01 dop: 1996-09-01 dow: 1996-09-01
Note : EN following parallel vote
Retour aux "Directives européennes" ou au "Contenu".
Terug naar "Europese richtlijnen" of naar "Inhoud".
Back to "EC Directives" or to "Contents".
7