AS ISO 14602-2003

1 - AS ISO 14602-2003 NON-ACTIVE SURGICAL IMPLANTS-IMPLANTS FOR OSTEOSYNTHESIS-PARTICULAR REQUIREMENTS
4 - PREFACE
5 - CONTENTS
6 - INTRODUCTION
7 - 1 Scope
7 - 2 Normative references
7 - 3 Definitions
7 - 3.1 non-active surgical implant for osteosynthesis:
7 - 4 Intended performance
7 - 4.1 Functional characteristics
8 - 4.2 Typical clinical applications
8 - 4.3 Conditions of use
9 - 5 Design attributes
9 - 6 Materials
9 - 7 Design evaluation
9 - 7.1 General
9 - 7.2 Preclinical evaluation
10 - 8 Manufacturing
10 - 9 Sterilization
10 - 10 Packaging
10 - 11 Information supplied by manufacturer
10 - 11.1 Particular conditions for use
10 - 11.2 Marking on implants
11 - Annex A - ISO standards referring to implants and associated instruments found acceptable through clinical use for given...
11 - A.1 Types of osteosynthesis implants and related ISO standards
12 - A.2 ISO standards related to associated instruments
13 - Annex B - ISO Standards referring to materials found acceptable through proven clinical use.
14 - ANNEX C - Standards related to testing and design evaluation