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

Foreword

YY/T 0727 "surgical implants metal intramedullary nail system" is divided into three parts.

--- Part 1. intramedullary nail;

--- Part 2. locking member;

--- Part 3. Connect the instrument to expand the canal and diameter measurements. This section YY/T Section 20727 of.

This part identical with ISO 15142-2:2003 "surgical implants metal nail systems - Part 2. locking member." For ease of use, this section made the following editorial changes.

a) "this International Standard" be replaced by "this section";

b) the normative references have been converted to equivalent national standards or industry standards with international standards with national standards or industry standards instead;

c) Remove the foreword and introduction of international standards.

This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.

This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.

1 Scope

YY/T 0727 provisions of this part of the way by a surgical implant for temporary fixation within the bone marrow long metal medical devices. Given Classification and requirements intramedullary nail locking member.

This section applies to all human long bone intramedullary temporary fixing metal fixation devices. This section does not apply to non-interlocking intramedullary nail.

2 Normative references

The following documents contain provisions which, through reference YY/T 0727 to the present, constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 12417.1 active surgical implants bone and joint replacement implants - Part 1. Particular requirements for osteosynthesis implants (GB/T 12417.1-2008, ISO 14602:1998, IDT)

GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-2008, ISO 10993-3:2003, IDT)

GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (GB/T 16886.4-2003, ISO 10993-4:2002, IDT)

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003, ISO 10993-5:1999, IDT)

Qualitative and quantitative framework for potential degradation products. GB/T 16886.9 Biological evaluation of medical devices - Part 9 (GB/T 16886.9-2001, ISO 10993-9:1999, IDT)

GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (GB/T 16886.10-2005, ISO 10993-10:2002, IDT)

GB/T 16886.13 Biological evaluation of medical devices - Part 13. qualitative and quantitative degradation products from polymeric medical devices (GB/T 16886.13-2001, ISO 10993-13:1998, IDT)

GB/T 16886.14 Biological evaluation of medical devices - Part 14. Ceramic degradation products of qualitative and quantitative (GB/T 16886.14-2003, ISO 10993-14:2001, IDT)

GB/T 16886.15 Biological evaluation of medical devices - Part 15. degradation products from metals and alloys qualitative and quantitative (GB/T 16886.15-2003, ISO 10993-15:2000, IDT)

GB/T 16886.16 Biological evaluation of medical devices - Part 16. degradation products and leachables Toxicokinetic study design (GB/T 16886.16-2003, ISO 10993-16:1997, IDT)

GB/T 16886.17 Biological evaluation of medical devices - Part 17. leachables allow the establishment of a limited amount of (GB/T 16886.17-2005, ISO 10993-17:2002, IDT)

YY/T 0316 Medical Devices Risk Management for Medical Device Applications (YY/T 0316-2008, ISO 14971-1:2007, IDT)

YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630:2005, IDT)

ISO 5835 (all parts) surgical implant metal bone screw size