| Standard
reference |
Titles |
Ratification
date |
| EN 540 |
Clinical investigation
of medical devices for humans |
1993 |
| EN 550 |
Sterilization of medical
devices - Validation and routine control of ethylene oxide sterilisation |
1994 |
| EN 552 |
Sterilization of medical
devices - Validation and routine control of sterilisation by irradiation |
1994 |
| EN 554 |
Sterilization of medical
devices - Validation and routine control of sterilisation by moist heat |
1994 |
| EN 556 |
Sterilization of medical
devices - requirements for medical devices to be labelled "Sterile" |
1994 |
| EN 868-1 |
Packaging materials and
systems for medical devices which are to be sterilized - Part 1 : general
requirements and test methods |
1997 |
| EN 980
A1 |
Graphical symbols for use
in the labelling of medical devices |
1996
1999 |
| EN 1041 |
Information supplied by
the manufacturer with medical devices |
1998 |
| EN 1174-1 |
Sterilization of medical
devices - Estimation of the population of micro-organisms on product -
Part 1 : requirements |
1996 |
| EN 1174-2 |
Sterilization of medical
devices - Estimation of the population of micro-organisms on product -
Part 2 : guidance |
1996 |
| EN 1174-3 |
Sterilization of medical
devices - Estimation of the population of micro-organisms on product -
Part 3 : guide to the methods for validation of microbiological techniques |
1996 |
| EN 1441 |
Medical devices – risk
analysis |
1997 |
| EN ISO 10993-1 |
Biological evaluation of
medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) |
1997 |
| EN ISO 10993-5 |
Biological evaluation of
medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) |
1999 |
| EN ISO 10993-9 |
Biological evaluation of
medical devices – Part 9: Framework for identification and quantification
of potential degradation products (ISO 10993-9:1999) |
1999 |
| EN ISO 10993-10 |
Biological evaluation of
medical devices - Part 10 : tests for irritation and sensitization (ISO
10993-10:1995) |
1995 |
| EN ISO 10993-12 |
Biological evaluation of
medical devices - Part 12 : sample preparation and reference materials
(ISO 10993-12:1996) |
1996 |
| EN ISO 10993-13 |
Biological evaluation of
medical devices - Part 13: Identification and quantification of degradation
products from polymeric medical devices (ISO 10993-13:1998) |
1998 |
| EN ISO 10993-16 |
Biological evaluation of
medical devices – Part 16: toxicokinetic study design for degradation products
and leachables (ISO 10993-16:1997) |
1997 |
| EN 30993-3 |
Biological evaluation of
medical devices - Part 3 : tests for genotoxicity, carcinogenicity and
reproductive toxicity (ISO 10993-3:1992) |
1993 |
| EN 30993-4 |
Biological evaluation of
medical devices - Part 4 : selection of tests for interactions with blood
(ISO 10993-4:1992) |
1993 |
| EN 30993-5 |
Biological evaluation of
medical devices - Part 5 : tests for cytotoxicity - in vitro methods (ISO
10993-5:1992) |
1993 |
| EN 30993-6 |
Biological evaluation of
medical devices - Part 6: Tests for local effects after implantation (ISO
10993-6:1994) |
1994 |
| EN 30993-7 |
Biological evaluation of
medical devices - Part 7: ethylene oxide sterilisation residuals (ISO 10993-7:1995) |
1995 |
| EN 30993-11 |
Biological evaluation of
medical devices - Part 11: tests for systemic toxicity (ISO 10993-11:1993) |
1995 |
| EN 45502-1 |
Active implantable medical
devices – Part 1: General requirements for safety, marking and information
to be provided by the manufacturer |
1997 |
| EN 46001 |
Quality systems - Medical
devices - Particular requirements for the application of EN ISO 9001 |
1995 |
| EN 46002 |
Quality systems - Medical
devices - Particular requirements for the application of EN ISO 9002 |
1995 |
| EN 46003 |
Quality systems - Medical
devices - Particular requirements for the application of EN ISO 9003 |
1999 |
| EN 50103 |
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 |
1994 |
| EN 60601-1 |
Medical electrical equipment.
Part 1: General requirements for safety - IEC 601-1:1988 |
1990 |
| Amendment A1 to EN 60601-1 |
Medical electrical equipment.
Part 1: General requirements for safety - IEC 601-1:1988/A1:1991 |
1992 |
| Amendment A2 to EN 60601-1 |
Medical electrical equipment.
Part 1: General requirements for safety - IEC 601-1:1988/A2:1995 + corrigendum
Jun. 1995 |
1995 |
| Amendment A13 to EN 60601-1 |
Medical electrical equipment.
Part 1: General requirements for safety |
1995 |
