YY/T 0920-2014: Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

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Scope

This standard specifies specific requirements for hip joint replacement implants.
With regard to safety, this standard specifies requirements for expected performance,
design attributes, materials, design evaluation, fabrication, sterilization, packaging, and
information provided by the manufacturer, as well as test methods.

Basic Data

Standard ID	YY/T 0920-2014 (YY/T0920-2014)
Description (Translated English)	Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	12,125
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	YY/T 0640-2008; YY/T 0809.1; YY/T 0809.2-2010; YY/T 0809.4; YY/T 0809.6-2010; YY/T 0809.10; ISO 21534-2007
Adopted Standard	ISO 21535-2007, IDT
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to hip replacement implants. This Standard specifies the expected performance of hip replacement implants, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manuf