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YY/T 0727.3-2009Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter measurements (English PDF)

外科植入物 金属髓内钉系统 第3部分:连接器械及髓腔扩大器直径的测量

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 25, 2009

Implementation date

December 1, 2010

Scope

YY/T 0727.3-2009 is the English-translated version of 外科植入物 金属髓内钉系统 第3部分:连接器械及髓腔扩大器直径的测量.

YY/T 0727.3-2009 is the Chinese pharmaceutical industry standard for the connection devices of a metal intramedullary nailing system, the instruments with which a nail is inserted and extracted, and it also fixes the measurement of the diameter of the canal reamer.

It is the third part of the YY/T 0727 series and gives the classification, the dimensions and the other requirements for those instruments. Issued on 25 November 2009, it has applied since 1 December 2010.

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Document preview — YY/T 0727.3-2009

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Classification and Design

Foreword

YY/T 0707 "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 30727 of.

This part identical with ISO 15142-3:2003 "surgical implants metal nail systems - Part 3. Connect the instrument and the canal expansion The diameter of the measuring amplifier. " 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 international standards with the subject line instead of standard line;

c) Remove the foreword and introduction of international standards.

Appendix A of this section is normative appendix, Appendix B is an informative annex.

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 marrow Nail insertion and classification, dimensions and other requirements out instruments, and also gives a measurement amplifier canal diameter.

This section applies to all human long bone intramedullary temporary fixing metal fixation devices.

This section does not apply to twist locking connector part member.

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.

YY/T 0727.2 metal surgical implant intramedullary nail system - Part 2. locking member (YY/T 0727.2-2009, ISO 15142-2:2003, IDT)

ISO 8319 (all parts) orthopedic surgical instrument twist connector

3 Terms and definitions

The following terms and definitions apply YY/T 0727 to the present section.

3.1 Intramedullary nail portion for connection to the locking member and the insertion/withdrawal instrument. Example: pores, openings, slots or threaded. [YY/T 0727.1-2009, the definition 3.5]

3.2 Connection device

To assist intramedullary nail insertion and (or) removal, temporary connection to the intramedullary nail by nail instrument connecting member. Example: twist handle, bit holder, remove the bolts or hooks. [YY/T 0727.1-2009, the definition 3.10]

4 Classification and Design

Insert (remove) the instrument should contain.

a) hook;

b) a corresponding externally threaded member. Requirement 5 insert (remove) the instrument

5.1 General requirements

All nail should have a structure with the insertion and removal of the auxiliary tool connection (connecting member), the insert (remove) the instrument can

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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