YY 0120-2002Implants for osteosynthesis - Metal orthopaedic rods (English PDF)
骨接合植入物 金属矫形用棒
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
September 24, 2002
Implementation date
April 1, 2003
Scope
YY 0120-2002 is the English-translated version of 骨接合植入物 金属矫形用棒.
YY 0120-2002 is the Chinese pharmaceutical industry standard for metal orthopaedic rods, the spinal rods used for correction and internal fixation when the vertebrae are diseased or deformed.
It sets out the classification and product model designation, the requirements for stainless steel to GB/T 4234 or titanium alloy to GB/T 13810, hardness, tensile strength, corrosion resistance, surface quality - free of sharp edges and burrs, with clear knurling and thread - and dimensions.
The test methods refer to GB/T 4340 for Vickers hardness, GB/T 228, YY 0341 and YY/T 0343. It replaces YY 0120-1993. Issued on 24 September 2002, it has applied since 1 April 2003.
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Document preview — YY 0120-2002
National Standard of the People's Republic of China
- Replacing
- YY 0120-1993
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Classification4
- 4 Requirements9
- 5 Test methods10
- 6 Inspection rules11
- 7 Instructions for use11
- 8 Marks11
- 9 Packaging11
- 10 Transportation and storage11
- 11 Requirements for use11
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
4 Requirements
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.
5.5.3 Appearance requirements: Visually observe, which shall meet the provisions of 4.4.3 and 4.4.4.
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.
5.6 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. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- YY/T 0343Liquid penetrant inspection of metallic surgical implants
GB/T 228 · GB/T 4234 · GB/T 4340
Similar standards
Editions of YY 0120
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0120-2002 | Implants for osteosynthesis - Metal orthopaedic rods | current edition | Current |
| YY 0120-1993 | Implants for osteosynthesis - Metal orthopaedic rods | previous edition | Superseded |
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Related Standards
GB/T 13810-2017 — Wrought titanium and titanium alloys for surgical implants
GB/T 228.1-2021 — Metallic Materials — Tensile Testing — Part 1: Method of Test at Room Temperature
GB/T 228.2-2015 — Metallic materials -- Tensile testing -- Part 2: Method of test at elevated temperature
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