This Standard specifies the definitions, classification, intended performance, requirements, test methods, inspection rules, marking, instructions for use, packaging, transportation, and storage of knee joint prostheses. This Standard is applicable to non-active surgical implants that replace partial or full knee joint of human body.
Basic Data
Standard ID
YY 0502-2005 (YY0502-2005)
Description (Translated English)
Knee joint prostheses
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
22,268
Date of Issue
2005-12-07
Date of Implementation
2006-12-01
Quoted Standard
GB/T 2828.1; GB/T 2829; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB/T 19701.2; GB/T 19633; YY 0117-2005; YY 0341; YY 0343; HB/Z 60; ISO 7207-1; ISO 7207-2; ISO 13779-3
Adopted Standard
ISO 14630-1997, NEQ; ISO 21534-2002, NEQ; ISO 21536-2002, NEQ; ISO 7207-1-1994, NEQ; ISO/FDIS 7207-2-1998, NE
Regulation (derived from)
Industry Standard Notice 2006 No. 2 (No. 74 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the knee prosthesis definition, classification, expected performance, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage requirements. This standard applies to the human body part or all of the purposes of the passive knee replacement surgical implants.
