YY/T 0345.1-2020Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements (English PDF)
外科植入物 金属骨针 第1部分：通用要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 0345.1-2020 is the English-translated version of 外科植入物 金属骨针 第1部分：通用要求.
YY/T 0345.1-2020 is the Chinese standard "Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements". Its scope clause reads: This Part of YY/T 0345 specifies the general requirements for metallic skeletal pins and wires used for orthopedic surgery.
This Part applies to metallic skeletal pins and wires used for orthopedic surgery, but not to bundled and wound metal wires.
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Document preview — YY/T 0345.1-2020
National Standard of the People's Republic of China
- Replacing
- YY/T 0345.1-2011
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope6
- 2 Normative References6
- 3 Materials7
- 4 Mechanical Properties7
- 5 Manufacturing Method8
- 6 Surface Quality8
- 7 Sterilization8
- 8 Packaging8
- 9 Information Provided by the Manufacturer8
1 Scope
This Part of YY/T 0345 specifies the general requirements for metallic skeletal pins and wires used for orthopedic surgery.
This Part applies to metallic skeletal pins and wires used for orthopedic surgery, but not to bundled and wound metal wires.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 228.1 Metallic Materials - Tensile Testing - Part 1.Method of Test at Room Temperature (GB/T 228.1-2010, ISO 6892-1.2009, MOD)
GB 4234.1 Implants for Surgery - Metallic Materials - Part 1.Wrought Stainless Steel (GB 4234.1-2017, ISO 5832-1.2007, MOD)
GB/T 4334 Corrosion of Metals and Alloys - Test Methods for Intergranular Corrosion of
Stainless Steels (GB/T 4334-2008, ISO 3651-1.1998 & ISO 3651-2.1998, MOD)
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants
GB 23102 Implants for Surgery - Metallic Materials - Wrought Titanium-6aluminium-
7niobium Alloy (GB 23102-2008, ISO 5832-11.1994, IDT)
YY/T 0605.5 Implants for Surgery - Metallic Materials - Part 5.Wrought Cobalt-chromium- tungsten-nickel Alloy (YY/T 0605.5-2007, ISO 5832-5.2005, IDT)
YY/T 0605.6 Implants for Surgery - Metallic Materials - Part 6.Wrought Cobalt-nickel- chromium-molybdenum Alloy (YY/T 0605.6-2007, ISO 5832-6.1997, IDT)
YY/T 0605.7 Implants for Surgery - Metallic Materials - Part 7.Forgeable and Cold-formed
Cobalt-chromium-nickel-molybdenum-iron Alloy (YY/T 0605.7-2007, ISO 5832-7.1994, IDT)
YY/T 0605.8 Implants for Surgery - Metallic Materials - Part 8.Wrought Cobalt-nickel- chromium-molybdenum-tungsten-iron Alloy (YY/T 0605.8-2007, ISO 5832-8.1997, IDT)
YY/T 0346-2022 | YY 0341.1-2020 | YY 0341.2-2020 | YY/T 0345.3-2014 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 228.1Metallic Materials — Tensile Testing — Part 1: Method of Test at Room Temperature
- GB 4234.1Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
- GB/T 4334Corrosion of metals and alloys - Test methods for intergranular corrosion of austenitic and ferritic-austenitic (duplex) stainless steels
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- GB 23102Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
- YY/T 0605.5Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
Similar standards
Editions of YY/T 0345.1
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0345.1-2020 | Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements | current edition | Current |
| YY/T 0345.1-2011 | Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements | previous edition | Superseded |
This page sells the current edition, YY/T 0345.1-2020. Earlier editions are listed for reference only.
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Related Standards
GB 23102-2008 — Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
GB 4234.1-2017 — Implants for surgery—Metallic materials—Part 1: Wrought stainless steel
GB 4234.1-2026 — Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
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YY/T 0345.1-2020
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