YY 0120-2002 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY 0120-2002: Implants for osteosynthesis--Metal correctional stick Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY 0120: Historical versions
Similar standardsYY 0120-2002: Implants for osteosynthesis--Metal correctional stick---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0120-2002YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 C 35 Replacing YY 0120-1993 Implants for osteosynthesis - Metal correctional stick ISSUED ON: SEPTEMBER 24, 2002 IMPLEMENTED ON: APRIL 01, 2003 Issued by: National Medical Products Administration Replaced Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Classification ... 4 4 Requirements ... 9 5 Test methods ... 10 6 Inspection rules ... 11 7 Instructions for use ... 11 8 Marks ... 11 9 Packaging ... 11 10 Transportation and storage ... 11 11 Requirements for use ... 11 Implants for osteosynthesis - Metal correctional stick1 ScopeThis Standard specifies classification, requirements, test methods, inspection rules, instructions for use, marks, packaging, transportation and storage for metal correctional stick [Translator note: Term “rod” is adopted in YY/T 0119.4- 2014]. This Standard is applicable to metal correctional stick (hereinafter referred to as the correctional stick). This product is used for correction and internal fixation when the spine bones are diseased or deformed.2 Normative referencesThe provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 228, Metallic materials - Tensile testing at ambient temperature GB/T 4234, Stainless steel for surgical implants GB/T 4340, Metallic materials - Vickers hardness test GB/T 13810, Wrought titanium and titanium alloy for surgical implants (GB/T 13810-1997, eqv ISO 5832-2: 1993) YY/T 0343, Liquid penetrant inspection of metallic surgical implants YY0341, General technological requirements for non-active metallic surgery implants of osteosynthesis3 Classification3.1 Example of product model of the correctional stick Table 5 4.4.3 The surface of the correctional stick shall be smooth and free of defects such as sharp edges (except the tip of the sacral thread), burrs, and attachments. 4.4.4 Net knurling and thread profile shall be clear and complete. 4.5 Size The D size of the correctional stick shall be checked during acceptance.5 Test methods5.1 Materials The chemical composition and microstructure inspection of the correctional stick products shall be carried out in accordance with the provisions in GB/T 4234 and GB/T 13810, which shall be in accordance with the provisions of 4.1. 5.2 Hardness inspection Carry out the test according to the method specified in GB/T 4340. Measure three points on the surface of the nail. Take the arithmetic average of the three points, which shall be in accordance with the provisions of 4.2. 5.3 Tensile strength inspection Carry out the test according to the method specified in GB/T 228, which shall be in accordance with the provisions of 4.2. 5.4 Corrosion resistance inspection Carry out the test according to the method specified in 5.3.1, 5.3.2 in YY 0341- 2002, which shall be in accordance with the provisions of 4.3.1. 5.5 Surface quality 5.5.1 Surface defect inspection: Carry out the test according to YY/T 0343, which shall meet the provisions of 4.4.1. 5.5.2 Surface roughness inspection: Carry out according to the sample block comparison method (or electrical measurement method), which shall meet the provisions of 4.4.2. 5.5.3 Appearance requirements: Visually observe, which shall meet the provisions of 4.4.3 and 4.4.4. 5.6 Size Use general measuring tools to test, which shall meet the provisions of 4.5.6 Inspection rulesThe inspection rules for the correctional stick shall comply with the provisions of Chapter 6 in YY 0341-2002.7 Instructions for useThe instructions for use for the correctional stick shall comply with the provisions of Chapter 7 in YY 0341-2002.8 MarksThe marks for the correctional stick shall comply with the provisions of Chapter 8 in YY 0341-2002.9 PackagingThe packaging for the correctional stick shall comply with the provisions of Chapter 9 in YY 0341-2002.10 Transportation and storageThe transportation and storage for the correctional stick shall comply with the provisions of Chapter 10 in YY 0341-2002.11 Requirements for useThe requirements for use for the correctional stick shall comply with the provisions of Chapter 11 in YY 0341-2002. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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