English
Korean
ICMC 소식 & 자료실
ICMC교육원
icmcert@naver.com
02-851-3111
유럽 의료기기 CE MDR
[EU]능동형 이식 의료기기 지침 AIMDD 기준규격(Active Implantable Medical Device Standards)
- 관리자
- 2008-06-13 20:25:00
- hit5947
- 61.80.23.39
Active Implantable Medical Device Standards
Latest update on 2000-12-18
| 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 |
기타 자세한 문의 사항은 유선상으로 상담드리겠습니다.
(Other detailed inquiry item will consult to line of flow.)
=========================================================
ICMC CO.,Ltd
(International Certification Management Center)
게시글 공유
URL복사
10004 certified
