EN ISO 14602:2011

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

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.