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YY 0502-2005 English PDF

YY 0502-2005 English PDF

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YY 0502-2005: Knee joint prostheses

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Scope

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.


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