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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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