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YY/T 0920-2014 English PDF (YY/T0920-2014)
YY/T 0920-2014 English PDF (YY/T0920-2014)
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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 |
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