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YY/T 1137-2017 PDF English


Search result: YY/T 1137-2017 English: PDF (YY/T1137-2017)
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YY/T 1137-2017English150 Add to Cart 0-9 seconds. Auto-delivery. General technique requirements for orthopaedics saw Valid
YY 1137-2005English319 Add to Cart 3 days General technical requirements for orthopaedics saw Obsolete
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YY/T 1137-2017: PDF in English (YYT 1137-2017)

YY/T 1137-2017 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 C 35 Replacing YY 1137-2005 General technique requirements for orthopaedics saw ISSUED ON. MAY 2, 2017 IMPLEMENTED ON. APRIL 1, 2018 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Classification ... 4  4 Requirements ... 5  5 Test methods ... 6  6 Marking ... 7  7 Packaging, transport, storage ... 8  Appendix A (Normative) Bending resistance test ... 9  References ... 11  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). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority 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 Implants for Surgery and Orthopedic Devices of Standardization Administration of China (SAC/TC 110). Drafting organizations of this Standard. Tianjin Medical Device Quality Supervision and Inspection Center, Naton Intl. Orthopaedic Research Center, Beijing Fule Science & Technology Development Co., Ltd. Main drafters of this Standard. Li Nan, Duan Qingjiao, Jiang Yao, Li Renyao, Qiu Wanyu, Guo Zixue. The previous releases of versions of YY 1137-2005 and YY 1137 replaced by this Standard are. - WS 2-199-1975; - YY 91137-1999. General technique requirements for orthopaedics saw 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. Table 1 -- Classification of orthopaedics saw products For cutting bones For cutting plaster Blade saw Wire saw Plaster saw certificate. a) Manufacturer’s name; b) Inspector’s code; c) Date of inspection. 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. ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.