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YY/T 1122-2017General technical requirements for orthopaedic bone rongeurs (scissors) (English PDF)

咬骨钳(剪)通用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 28, 2017

Implementation date

April 1, 2018

Scope

YY/T 1122-2017 is the English-translated version of 咬骨钳(剪)通用技术条件.

YY/T 1122-2017 is the Chinese pharmaceutical industry standard for orthopaedic clamps and scissors.

It sets the material, the hardness, the corrosion resistance, the surface quality, the basic dimensions and the usability of these instruments, together with the test methods and the marking, so that an instrument that must cut or hold bone and tissue under load performs and lasts as expected. Issued on 28 March 2017, it has applied since 1 April 2018.

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Document preview — YY/T 1122-2017

National Standard of the People's Republic of China

Replacing
YY 1122-2005

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

Contents

  • Foreword3
  • 1 Scope5
  • 2 Normative references5
  • 3 Terms and definitions6
  • 4 Requirements6
  • 5 Test methods7
  • 6 Marking8
  • Bibliography9

Foreword

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

This Standard replaces YY 1122-2005, General technique requirements for orthopaedics clamp (scissor), and YY/T 1127-2006, Rongeur. Compared with YY 1122- 2005 and YY/T 1127-2006, the major technical changes are as follows.

-- it adds the new standards YY/T 0294.1 and ASTM F899 in the material requirements (see 4.1);

-- it standardizes the hardness requirements and adds the new Vickers hardness test method (see 4.2);

-- it specifies that the roughness measurement locations are the working surfaces (see 4.4.1);

-- it deletes the inspection rules (see Clause 6 of YY 1122-2005 and YY/T 1127-

2006), instructions for use (see 7.2 of YY 1122-2005) and packaging, transportation and storage (see Clause 8 of YY 1122-2005 and YY/T 1127).

1 Scope

This Standard specifies the material, hardness, corrosion resistance, surface quality, basic dimensions, usability, test methods and marking for orthopaedics clamps (scissors).

This Standard applies to orthopaedics clamps (scissors) which are used to cut or correct bones.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this document.

GB/T 191, Packaging - Pictorial marking for handling of goods

GB 4793.1, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1. General requirements

GB 4793.9, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes

GB/T 230.1, Metallic materials - 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 1910, Newsprint

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

4 Requirements

4.4.2 Appearance

The appearance of orthopaedics clamps (scissors) shall be smooth and symmetrical without sharp edges, burrs or cracks. The handle part can be provided with patterns or none and the patterns on the handle shall be clear and complete.

4.5 Dimensions

The basic dimensions and tolerances of orthopaedics clamps (scissors) shall be as specified in the technical requirements of products.

4.6 Usability

4.6.1 The cutting edge of orthopaedics clamps (scissors) shall be sharp without tipping or flaking. After orthopaedics clamps (scissors) are closed, their clamp head shall be matched to each other without staggering.

4.6.2 The grill shaft bolt shall be fixed on one piece of clamps (scissors) securely; when orthopaedics clamps (scissors) are open, the bolt shall not move with them.

4.6.3 When orthopaedics clamps (scissors) are open, the grill part and the joint shall be relaxed, without swinging or locking.

5 Test methods

5.1 Material

Use the approved method for chemical analysis to carry out test and the results shall be as specified in 4.1.

5.2 Hardness

As specified in GB/T 230.1 or GB/T 4340.1, measure three points respectively on the surface of the head of the pieces on the left and right; take the arithmetic mean value of the three points of each location; and the results shall be as specified in 4.2.

5.3 Corrosion resistance

Carry out test using the boiling water method specified in YY/T 0149-2006 and the results shall be as specified in 4.3.

5.4 Surface quality

5.4.1 The surface roughness inspection shall be carried out using the electrical measuring method or sample piece comparison method as specified in GB/T 10610.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

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Editions of YY/T 1122

EditionTitleRevisionStatus
YY/T 1122-2017General technical requirements for orthopaedic bone rongeurs (scissors)current editionCurrent
YY 1122-2005General technical requirements for orthopaedic bone rongeurs (scissors)previous editionSuperseded

This page sells the current edition, YY/T 1122-2017. Earlier editions are listed for reference only.

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