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YY/T 0662-2008Implants for surgery-Metal bone screws with asymmetrical thread and spherical under-surface-Mechanical requirements and test methods (English PDF)

外科植入物 不对称螺纹和球形下表面的金属接骨螺钉 机械性能要求和试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

June 1, 2009

Scope

YY/T 0662-2008 is the English-translated version of 外科植入物 不对称螺纹和球形下表面的金属接骨螺钉 机械性能要求和试验方法.

YY/T 0662-2008 is the Chinese pharmaceutical industry standard, adopted from ISO 6475:1989, that gives the mechanical test for metal bone screws with an asymmetrical thread and a spherical under-surface: the determination of the maximum torque at fracture and of the torsional angle at fracture.

It specifies the test equipment, with its minimum sensitivity, torque recording and a means of keeping the screw from slipping, and the procedure: clamping the screw with five complete threads exposed, applying torque to the head at a constant 1 r/min to 5 r/min until it breaks, and repeating the test on a lower range when the result falls below 20% of full scale.

Performance requirements for stainless steel screws to ISO 5832-1 and ISO 5835 are given in Annex A. Issued on 25 April 2008, it has applied since 1 June 2009.

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Document preview — YY/T 0662-2008

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

Foreword

This standard is identical with ISO 6475. 1989 "surgical implants asymmetrical thread and spherical under surface of the metal bone screw machinery And test methods "performance requirements.

Appendix A of this standard is a normative appendix, Appendix B and Appendix C are informative appendices.

1 Scope

This standard specifies the test method for testing a surgical screw breakage torque and torsion angle fracture with metal bone. Bone screw machine Performance requirements in Appendix A.

Note 1. The current data only applies to stainless steel in accordance with ISO 5832-1 and ISO 5835 compliance with the provisions of the size of the bone screw. When access to other material When the material and/or other standards consistent with the size of bone screws data, which will be added to a new appendix.

Note 2. The relationship between the relevant plates, bone screws and relevant international standards between the tools, see Appendix B.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

ISO 5832-1 Implants for surgery - Metallic materials - Part 1. Forged steel

ISO 5835 surgical implant hexagonal drive connection, spherical under surface, asymmetrical thread metal bone screw size Test Method 3

3 Test method

3.1 Device

Test equipment should be used with the following characteristics.

a) the maximum sensitivity on the lowest range of not less than 0.01N · m or equivalent, full-scale reading on other range maximum flexibility Acuity less than 1%; Select b) range (see 3.2.4);

c) can be recorded when the test reaches maximum torque;

d) preventing screw element off from means for applying torque.

Note: The test equipment must meet the requirements specified in the national testing body.

3.2 Program

3.2.1 The bone screw inserted into the jaw and locking device, so that should meet the following conditions.

a) when possible, thread the tail should have five complete threads exposed;

Note: From the tail of the thread holding position, counting direction of the screw head, there are five complete threads exposed.

b) clamping parts not loose;

c) screw axis coincident with the axis element should be applied torque.

3.2.2 Select a constant angular velocity in 1r/min ~ 5r/min within the range of the torque applied to the screw head in a row until the occurrence of a screw fracture.

3.2.3 record the maximum torque fracture and fracture torsion angle.

3.2.4 If the record of the maximum fracture torque is less than 20% of full scale reading test, the results should be ignored, and heavy on the lower one range Repeat the above test.

Note: The use of electronic torsion testing machine, within the range of measurement precision, the results should be valid.

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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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