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UNI EN ISO 14602 : 2012

Current

Current

The latest, up-to-date edition.

NON-ACTIVE SURGICAL IMPLANTS - IMPLANTS FOR OSTEOSYNTHESIS - PARTICULAR REQUIREMENTS

Published date

02-02-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by manufacturer
Annex A (informative) - Correspondence of the clauses of
        this International Standard to the fundamental
        principles outlined in ISO/TR 14283
Annex B (informative) - ISO standards referring to implants
        and associated instruments found acceptable through
        clinical use for given applications in osteosynthesis
Annex C (informative) - ISO Standards referring to materials
        found acceptable through proven clinical use
Annex D (informative) - Standards related to testing and
        design evaluation
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Describes particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.

Committee
CT 44
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

ISO 14630:2012 Non-active surgical implants General requirements
ISO/TR 14283:2004 Implants for surgery Fundamental principles

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