BS EN ISO 14602:2010 Non-active surgical implants. Implants for osteosynthesis. Particular requirements
BS EN ISO 14602 is an International Standard which specifies particular requirements for non-active surgical implants for osteosynthesis.
In addition to BS EN ISO 14630, BS EN ISO 14602 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
Contents of BS EN ISO 14602:
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
4.1 General
4.2 Intended purpose
4.3 Functional characteristics
4.4 Intended conditions of use
5 Design attributes
6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by manufacturer
11.1 General
11.2 Labelling
11.3 Instructions for use
11.4 Restrictions on combinations
11.5 Marking on implant
11.6 Marking for special purposes
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
