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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, inspectionrules, 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Older Standard (superseded by this standard) | YY 0341-2002 |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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