This Standard specifies the requirements for terms and definitions, classification and dimension marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, package, and information provided by the manufacturer of the knee joint prostheses. This Standard is applicable to partial or total knee joint prostheses manufactured by the materials and processes specified in this Standard.
China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the terms and definitions, classification and dimensioning, expected properties, design properties, materials, design evaluation, manufacturing, sterilization, packaging, and information requirements of the manufacturer of knee prostheses. This standard applies to partial and total knee prostheses made using the materials and processes specified in this standard.
