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MEDDEV 2.5-7 : REV 1 : 1998

MEDDEV 2.5-7 : REV 1 : 1998

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

Withdrawn date

02-02-2023

Published date

07-01-1998

Publisher

European Union

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Withdrawn

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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