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

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY 0341-2009 (Self-service in 1-minute)
Newer / historical versions: YY 0341-2009

Preview True-PDF

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Older Standard (superseded by this standard)	YY 0341-2002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.