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YY 0341-2009 English PDF

YY 0341-2009 English PDF

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YY 0341-2009: General technological requirements for non-active metallic surgical implants for osteosynthesis

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Scope

This Standard specifies the definitions, requirements, testing methods, inspection
rules, usage instructions, marks, packaging, transportation, storage, usage
requirements etc. of the non-active surgical implants for osteosynthesis.
This Standard is applicable to non-active surgical implants for osteosynthesis
(abbreviated as “implants for osteosynthesis”) which are made of metallic materials.
This Standard is not applicable to implants for osteosynthesis which have coating on
the surface.

Basic Data

Standard ID YY 0341-2009 (YY0341-2009)
Description (Translated English) General technological requirements for non-active metallic surgical implants for osteosynthesis
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 16,158
Date of Issue 2009-12-30
Date of Implementation 2011-06-01
Older Standard (superseded by this standard) YY 0341-2002
Quoted Standard GB/T 191; GB/T 228; GB/T 2829; GB/T 4340.1; GB/T 14233.2; GB/T 15239; GB/T 16886.1; YY/T 0343; YY/T 0640-2008; YY/T 1074
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the definition, requirements, test methods, inspection rules, instructions, instructions, packaging, transportation and storage and use requirements of passive surgical implants for bone bonding. This standard applies to the use of metal materials made of bone graft with passive surgical implant (referred to as "bone graft"). This standard does not apply to bone grafting with surface coating.


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