YY/T 0508-2009Specific requirements for external fixation devices (English PDF)
外固定支架专用要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0508-2009 is the English-translated version of 外固定支架专用要求.
YY/T 0508-2009 is the Chinese medical device industry standard, recommended in status, for external fixation devices. It gives the classification of these devices and lays down requirements, test methods, inspection rules, marking, packaging, transport and storage.
Its scope is orthopedic external fixation, and bone needles are not covered by it. Within the medical device sector it belongs to the surgical implant group, classified C35 under ICS 11.040.40.
The standard draws on GB/T 1220, GB/T 2828.1, GB/T 3191, GB 4234, GB/T 13810, GB/T 14233.1, GB/T 14233.2, YY/T 0149-2006 and YY/T 1052. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0508-2009
National Standard of the People's Republic of China
- ICS
- 11.040.40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0508-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 1220
GB/T 2828.1
GB/T 3191
GB 4234
GB/T 13810
GB/T 14233.1
GB/T 14233.2
YY/T 0149-2006
YY/T 1052
......
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 1220Stainless steel bars
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 3191Extrusion rods and bars of aluminium and aluminium alloys
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 4234
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Related Standards
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
GB 4234.11-2025 — Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
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