Standard No.:	YY 0502-2005
English Name:	Knee joint prostheses
Chinese Name:	膝关节假体
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	China Food and Drug Administration
Issued on:	2005-12-7
Implemented on:	2006-12-1
Status:	superseded
Superseded by:	YY 0502-2016 Joint replacement implants―Knee joint prostheses
Superseded on:	2018-1-1
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price(USD):	100.0
Delivery:	via email in 1 business day

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