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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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