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YY 0120-2002 PDF English

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YY 0120-2002: Implants for osteosynthesis--Metal correctional stick
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Status: Obsolete

YY 0120: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0120-2002English150 Add to Cart 0-9 seconds. Auto-delivery Implants for osteosynthesis--Metal correctional stick Obsolete
YY 0120-1993English559 Add to Cart 4 days (With metal orthopedic rod) Obsolete

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YY 0118   YY/T 0119.1   YY/T 0119.4   YY 0117.2   

YY 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/YY0120-2002
YY 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 Contents

Foreword ... 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 stick

1 Scope

This 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 references

The 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 osteosynthesis

3 Classification

3.1 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 methods

5.1 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 rules

The inspection rules for the correctional stick shall comply with the provisions of Chapter 6 in YY 0341-2002.

7 Instructions for use

The instructions for use for the correctional stick shall comply with the provisions of Chapter 7 in YY 0341-2002.

8 Marks

The marks for the correctional stick shall comply with the provisions of Chapter 8 in YY 0341-2002.

9 Packaging

The packaging for the correctional stick shall comply with the provisions of Chapter 9 in YY 0341-2002.

10 Transportation and storage

The transportation and storage for the correctional stick shall comply with the provisions of Chapter 10 in YY 0341-2002.

11 Requirements for use

The 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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