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YY/T 1122-2017 PDF English

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YY/T 1122-2017: General technique requirememts for orthopaedics clamp(scissor)
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YY/T 1122: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 1122-2017English120 Add to Cart 0-9 seconds. Auto-delivery General technique requirememts for orthopaedics clamp(scissor) Valid
YY 1122-2005English319 Add to Cart 3 days General technical requirements for orthopaedics clamp (scissor) Obsolete

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YY/T 1122-2017: General technique requirememts for orthopaedics clamp(scissor)

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YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 C 35 Replacing YY 1122-2005 and YY/T 1127-2006 General technique requirements for orthopaedics clamp (scissor) Issued on: MARCH 28, 2017 Implemented on: APRIL 1, 2018 Issued by. China Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 5 2 Normative references ... 5 3 Terms and definitions ... 6 4 Requirements... 6 5 Test methods ... 7 6 Marking ... 8 Bibliography ... 9

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). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuer of this document shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee 110 on Surgical Implants and Orthopaedic Instruments of Standardization Administration of China (SAC/TC 110). The drafting organizations of this Standard. Tianjin Centre for Quality Supervision and Testing of Medical Devices, Beijing Fule Technology Development Co., Ltd., Beijing Naton Medical Technology Institute Co., Ltd., Beijing Centre for Medical Device Evaluation. The main drafters of this Standard. Zhang Lu, Fu Ruizhi, Qiu Wanyu, Guo Zixue, Jiang Yao, Li Renyao, Yu Yong, Wang Chen. This Standard replaces YY 1122-2005 and YY/T 1127-2006. The previous editions of YY 1122-2005 are as follows. -- WS 2-54-1974 and YY 91122-1999; -- WS 2-182-1974 and YY 91134-1999. General technique requirements for orthopaedics clamp (scissor)

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 4.4.2 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. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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