MEDDEV 2.5-7 : REV 1 : 1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES
02-02-2023
01-07-1998
1. INTRODUCTION
2. GUIDELINES
3. REFERENCES
ANNEXES
Annex IA: informative annex relating to pre-clinical
investigation
Annex IB: informative annex relating to clinical
evaluation
Annex IC: informative annex relating to evaluation
and acceptability criteria to be used for the
clinical evaluation
Annex II: EQUAM Informative annex relating to
information to be provided to patients - patient
questionnaire and declaration of consent
Targets at promoting a common approach by the manufacturers of breast implants, the Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the MDD and by the Competent Authorities charged with safeguarding Public Health.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Miscellaneous Product
|
| PublisherName |
European Union
|
| Status |
Withdrawn
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| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| EN 12180 : 2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN 14630:2006 | Products and systems for the protection and repair of concrete structures - Test methods - Determination of carbonation depth in hardened concrete by the phenolphthalein method |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| EN 30993-1 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS |
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