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YY/T 0727.2-2009 English PDF

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YY/T 0727.2-2009: Implants for surgery. Metal intramedullary nailing systems. Part 2: Locking components
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YY/T 0727.2-2009English114 Add to Cart 3 days [Need to translate] Implants for surgery. Metal intramedullary nailing systems. Part 2: Locking components Valid YY/T 0727.2-2009

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Basic data

Standard ID YY/T 0727.2-2009 (YY/T0727.2-2009)
Description (Translated English) Implants for surgery. Metal intramedullary nailing systems. Part 2: Locking components
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 6,622
Date of Issue 2009-11-25
Date of Implementation 2010-12-01
Quoted Standard GB/T 12417.1; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.9; GB/T 16886.10; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; YY/T 0316; YY/T 0640; ISO 5835(����); ISO 8319(����); ISO 10993-1; ISO 10993-2; ISO 10993-6; ISO 10993-7; ISO 10993-11; ISO 10993-12; ISO 10993-18; ISO 10993-19; ISO 10993-20
Adopted Standard ISO 15142-2-2003, IDT
Regulation (derived from) Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: by way of surgical implants for the long bone temporarily fixed metal medical devices. Gives the intramedullary nail locking member classification and requirements. This standard applies to all human temporary fixation of long bone intramedullary fixation with metal. This standard does not apply to non-locking intramedullary nail.

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


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery.Metal intramedullary nailing systems.Part 2. Locking components ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards YY/T 0727.2-2009/ISO 15142-2.2003 Implants for surgery - Metal intramedullary nail system Part 2. locking member (ISO 15142-2.2003, IDT) Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued

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. The main drafters of this section. Wang Zuo Xiao, Li Nan, Dong Shuangpeng Song Duo. YY/T 0727.2-2009/ISO 15142-2.2003 Implants for surgery - Metal intramedullary nail system Part 2. locking member

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 YY/T 0727.2-2009/ISO 15142-2.2003

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