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YY/T 1141-2017General technical requirements for osteotomes (English PDF)

骨凿通用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 25, 2017

Implementation date

October 1, 2018

Scope

YY/T 1141-2017 is the English-translated version of 骨凿通用技术条件.

YY/T 1141-2017 is the Chinese pharmaceutical industry standard for the surgical osteotome, the chisel used on bone.

It sets the types and the basic dimensions, the material, the requirements, the test methods and the marking, covering the steel and its hardness, the corrosion resistance and surface quality, the geometry and the sharpness of the cutting edge and the strength of the instrument under impact. Issued on 25 September 2017, it has applied since 1 October 2018.

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Document preview — YY/T 1141-2017

National Standard of the People's Republic of China

Replacing: YY/T 91141-1999

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

Foreword3
1 Scope5
2 Normative references5
3 Terms and definitions5
4 Requirements5
5 Test methods7
6 Marking8

Foreword

This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces YY/T 91141-1999 "General technical conditions for osteotomes", YY 91071-1999 "Osteotomes", YY 91072-1999 "Gouges", and

YY 91073-1999 "Methods of test for cutting performance of chisels - Osteotomes Gouges". As compared with YY/T 91141-1999, YY 91071-1999,

YY 91072-1999, and YY 91073-1999, the main technical changes are as follows.

- MODIFY the requirements for material of osteotome;

- MODIFY hardness requirements;

- DELETE the surface finish requirement of osteotome, and CHANGE to the surface roughness requirement;

- MODIFY the use performance method of osteotome;

- DELETE the requirements for inspection rules, packaging, transport, and storage.

1 Scope

This Standard specifies the type and basic dimensions, material, requirements, test methods, and marking of osteotome. This Standard applies to surgical instruments used in orthopedic chisel.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the versions with the dates indicated are applicable to this document. For the undated references, the latest version (including all the amendments) are applicable to this document.

GB/T 230.1-2004 Metallic Rockwell hardness test - Part 1. Test method (scales A, B, C, D, E, F, G, H, K, N, T)

GB/T 1220 Stainless steel bars

GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test method

GB/T 10610 Geometrical product specifications (GPS) - Surface texture.

Profile method - Rules and procedures for the assessment of surface texture

YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance

YY/T 0294.1 Surgical instruments - Metallic materials - Part 1. Stainless steel

YY/T 1052 Marking requirements for surgical instruments

3 Terms and definitions

The following terms and definitions are applicable to this document. A chisel tool used to cut bones in orthopedic surgery.

4 Requirements

4.3.1.2.2 Gouge with bent head

When the head diameter is 6 mm or 8 mm, APPLY to the test piece with an acting force of 14000 N (test material with a hardness of not less than 28 HV1 or higher hardness, such as a flat fuse of 40 mm×15 mm×3.2 mm); the cutting depth shall be >=1.9 mm.

When the head diameter is 10 mm or 12 mm, APPLY to the test piece with an acting force of 14000 N (test material with a hardness of not less than 28 HV1 or higher hardness, such as a flat fuse of 40 mm×15 mm×3.2 mm); the cutting depth shall be >=1.7 mm.

4.3.2 Osteotome strength

The cutting edge of osteotome shall have good chiseling performance. The osteotome is hammered 10 times with a 1180 g drop hammer falling from a height of 260 mm. After chiseling, there shall be no curved blade or broken blade.

4.4 Hardness

The hardness of the head of osteotome shall not be less than 35 HRC or 350 HV10. The enterprise shall also specify the maximum hardness.

4.5 Dimensions

It shall comply with the technique requirements of the product.

4.6 Corrosion resistance

It shall not be lower than the requirements of Grade b of boiling water test method for corrosion resistance of medical instruments of stainless steel in YY/T 0149-2006.

5 Test methods

5.1 Material

The chemical composition shall be sampled on the final product. The test shall be carried out in accordance with the method specified in the standard of the selected material. It shall comply with the provisions of 4.1.

5.2 Surface quality

5.2.1 It shall be observed by eyesight or touched by hand. It shall meet the requirements of 4.4.1.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

Editions of YY/T 1141

Edition	Title	Revision	Status
YY/T 1141-2017	General technical requirements for osteotomes	current edition	Current
YY/T 91141-1999	General technical requirements for osteotomes	previous edition	Superseded

This page sells the current edition, YY/T 1141-2017. Earlier editions are listed for reference only.

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