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

Specifies particular requirements for non-active surgical implants for osteosynthesis that are in addition to the requirements outlined in the relevant parts of ISO 14630. The particular requirements proposed are for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

This European standard specifies particular requirements for non-active surgical Implants for osteosynthesis, hereafter referred to as implants.In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

First published as AS ISO 14602-2003.