This Standard specifies the terms and definitions, classification and size marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, packing, and manufacturer’s information requirements for the total-hip and partial-hip joint prostheses. This Standard is applicable to manufacture total-hip and partial-hip joint prostheses used the materials and processes specified in this Standard.
Basic Data
Standard ID
YY 0118-2016 (YY0118-2016)
Description (Translated English)
Joint replacement implants - Hip joint prostheses
Sector / Industry
Medical Device and Pharmaceutical Industry 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 of partial and total hip prostheses, the requirements for classification and dimensioning, expected performance, design properties, materials, design evaluation, manufacture, sterilization, packaging and information provided by the manufacturer. This standard applies to partial and total hip prostheses made using the materials and processes specified in this standard.
