This Standard specifies the definitions, classification, requirements, test methods, inspection rules, marking, packaging, instructions for use, transportation, storage etc. of total-hip and partial-hip joint replacements. This Standard is applicable to the joint prostheses used for the total-hip and partial-hip joint replacement of human body.
Basic Data
Standard ID
YY 0118-2005 (YY0118-2005)
Description (Translated English)
Hip 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
16,160
Date of Issue
2005-12-07
Date of Implementation
2006-12-01
Older Standard (superseded by this standard)
YY 0118-1993
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; YY 0117.1; YY 0117.2; YY 0117.3; YY 0341; YY/T 0343; ISO 6476; ISO 7206-1; ISO 7206-2; ISO 7206-4; ISO 7206-6; ISO 7206-8; ISO 13356; ISO 13779-2; ISO 14242-1; ISO 14242-2; IS
Adopted Standard
ISO 7206-1, NEQ; ISO 7206-2, NEQ; ISO 14630, NEQ; ISO 21534, NEQ; ISO 21535, NEQ
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 total hip and partial hip prosthesis definition, classification, requirements, test methods, inspection rules, marking, packaging, manual, transport and storage. This standard applies to the human body for full and partial hip replacement hip joint prosthesis.
