BS EN ISO 21534:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture and inspection
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - List of International Standards for
                        materials found acceptable for the
                        manufacture of implants
Annex B (informative) - List of International Standards for
                        materials found acceptable or not
                        acceptable for articulating surfaces
                        of implants
Annex C (informative) - List of materials found acceptable
                        or non-acceptable for metallic
                        combinations for non-articulating
                        contacting surfaces of implants
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

Describes particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants.

This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term \'implant\'.

It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.