YY/T 0727.2-2009
Implants for surgery.Metal intramedullary nailing system.Part 2:Locking components (English Version)

Standard No.

YY/T 0727.2-2009

Language

Chinese, Available in English version

Release Date

2009

Published By

Professional Standard - Medicine

Latest

YY/T 0727.2-2009

Scope

This part of YY/T 0727 specifies metal medical devices used for temporary fixation in long bone marrow by surgical implantation. Classification and requirements for intramedullary nail locking components are given. This section applies to all metal intramedullary fixation devices used for temporary fixation of human long bones. This section does not apply to non-locking intramedullary nails.

YY/T 0727.2-2009 Referenced Document

• GB/T 12417.1-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1:Particular requirements for osteosynthesis implants
• GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
• GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
• GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
• GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys
• GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables
• GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
• GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
• GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product
• ISO 5835:1991 Implants for surgery; metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread; dimensions
• YY/T 0316-2008 Medical devices.Application of risk management to medical devices
• YY/T 0640-2008 Non-active surgical implants-General requirements

YY/T 0727.2-2009 history

• 2009 YY/T 0727.2-2009 Implants for surgery.Metal intramedullary nailing system.Part 2:Locking components