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CEN
CEN/TS 15277:2006

CEN/TS 15277:2006

Current

Current

The latest, up-to-date edition.

Non-active surgical implants - Injectable implants

Published date

09-27-2006

Publisher

Comite Europeen de Normalisation

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Characteristics of injectable implants
  4.1 General
  4.2 Lifetime
      4.2.1 General
      4.2.2 Temporary injectable implants
      4.2.3 Permanent injectable implants
      4.2.4 Injectable implants composed of both temporary
            and permanent materials
  4.3 Clinical Compatibility
  4.4 Post-market surveillance
Annex A (informative) Overview of examples of injectable implants
Bibliography

This Technical Report gives characteristics of medical devices that are injectable implants, such as lifetime, migration, displacement, unintended degradation, impurity, infections, bio-incompatibility and clinical incompatibility.Pharmaceuticals, e.g. Botulinum-toxin, are not covered by the present document.

Committee
CEN/TC 285
DocumentType
Technical Specification
PublisherName
Comite Europeen de Normalisation
Status
Current

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