This standard specifies the definitions, classification, intended performance, requirements, test methods, inspection rules, marking, instructions for use, packaging, transportation and storage for knee joint prostheses.
This standard is applicable to non-active surgical implants for partial or total knee joint replacement of human body.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification, Dimensions and Illustrations
5 Intended Performance
6 Requirements
7 Test Methods
8 Inspection Rules
9 Packaging
10 Information Supplied by the Manufacturer
11 Transport and Storage
Appendix A (Normative) List of Standards for the Materials Found Acceptable For the Manufacture of Knee Joint Prostheses
Appendix B (Normative) List of Materials Found Acceptable or Not Acceptable for Use in Articulating Surfaces of Knee Joint Prostheses
Appendix C (Normative) List of Materials Found Acceptable or Non-Acceptable for Metallic Combinations for Non-Articulating Contacting Surfaces of Knee Joint Prostheses
Bibliography
