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YY/T 1137-2017General technical requirements for orthopaedic saws (English PDF)

骨锯通用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 2, 2017

Implementation date

April 1, 2018

Scope

YY/T 1137-2017 is the English-translated version of 骨锯通用技术条件.

YY/T 1137-2017 is the Chinese pharmaceutical industry standard for orthopaedic saws, the hand saws used to cut bone, and for plaster saws.

It gives the classification, the requirements, the test methods, the marking and the rules for packaging, transport and storage, covering the material and hardness of the blade, the teeth and their set, the corrosion resistance, the surface quality, the cutting performance and the strength of the frame and handle. Issued on 2 May 2017, it has applied since 1 April 2018.

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Document preview — YY/T 1137-2017

National Standard of the People's Republic of China

Replacing: YY/T 1137-2005

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

Foreword3
1 Scope4
2 Normative references4
3 Classification4
4 Requirements5
5 Test methods6
6 Marking7
7 Packaging, transport, storage8
Appendix A (Normative) Bending resistance test References9

Foreword

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

This Standard replaces YY 1137-2005 "General technique requirements for orthopaedics saw". As compared with YY 1137-2005, the main technical changes are as follows.

- ADD YY/T 0294.1 and ASTM F899 standards for "chemical composition" (SEE 4.2), and EXPAND the range of materials used;

- MAKE corresponding adjustments to appearance (SEE 4.3) and performance (SEE 4.4) requirements of the former standard;

- CHANGE the former standard's Rockwell hardness to Vickers hardness (SEE 4.5);

- ADD bending resistance (SEE 4.8 and Appendix A);

- DELETE the content of inspection rules (SEE Chapter 6 of YY 1137-2005).

1 Scope

This Standard specifies the classification, requirements, test methods, marking, packaging, transport, storage, etc. of orthopaedics saw.

This Standard applies to orthopaedics saws for cutting bones and plaster saws for cutting plaster.

2 Normative references

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

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 Standard.

GB/T 1184 Geometrical tolerancing - Geometrical tolerance for features without individual tolerance indications

GB/T 1220 Stainless steel bars

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

GB/T 8013.1 Anodic oxide coating and organic polymer coatings on aluminum and its alloys - Part 1. Anodic oxide coatings

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

YY/T 1052 Marking requirements for surgical instruments

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

3 Classification

The classification of orthopaedics saw products is shown in Table 1.

7 Packaging, transport, storage

7.1 Packaging

7.1.1 The orthopaedics saw shall, after rust-proof treatment, be placed in a neutral plastic bag. There shall be an inspection certificate in the bag. The bag needs to be sealed.

7.1.2 PUT the sealed orthopaedics saw into a packaging box. The box shall be labeled with a seal.

7.1.3 If there are special requirements, it shall be packaged according to the order contract.

7.2 Transport

The requirements for transport of orthopaedics saw shall be in accordance with the order contract.

7.3 Storage

The packaged orthopaedics saw shall be stored in a room with a relative humidity of no more than 80%, no corrosive gas, and good ventilation.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Normative references

Editions of YY/T 1137

Edition	Title	Revision	Status
YY/T 1137-2017	General technical requirements for orthopaedic saws	current edition	Current
YY/T 1137-2005	General technical requirements for orthopaedic saws	previous edition	Superseded

This page sells the current edition, YY/T 1137-2017. Earlier editions are listed for reference only.

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