YY/T 0509-2009Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants (English PDF)
生物可吸收内固定板和螺钉的标准要求和测试方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0509-2009 is the English-translated version of 生物可吸收内固定板和螺钉的标准要求和测试方法.
YY/T 0509-2009 is the recommended Chinese medical device standard covering bioabsorbable plates and screws used as internal fixation implants. It gives the specification and the test methods for the mechanical properties of fixation plates and screws made from hydrolysable, that is bioabsorbable, polymer resins.
It also defines the terms commonly used for the dimensions and other physical properties of absorbable surgical implants, and the terms describing the performance of absorbable medical devices.
Its test methods allow temperature, humidity and testing speed to be fixed beforehand, so that the mechanical behaviour of an absorbable implant can be followed continuously under those conditions.
Among the documents cited are YY/T 0473, YY/T 0474, YY/T 0640, YY/T 0661, ASTM F382 and ASTM F543. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0509-2009
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 0509-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
YY/T 0473
YY/T 0474
YY/T 0640
YY/T 0661
......
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
- YY/T 0473Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing
- YY/T 0474Surgical Implants - Polylactide Homopolymers, Copolymers, and Blends - In Vitro Degradation Tests
- YY/T 0640Non-active surgical implants - General requirements
- YY/T 0661Standard specification for semi-crystalline poly(lactide) polymer and copolymer resin for surgical implants
Similar standards
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Related Standards
YY/T 0473-2004 — Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing
YY/T 0474-2004 — Poly(L-lactide) resins and fabricated forms for surgical implants - In vitro degradation testing
YY/T 0474-2025 — Surgical Implants - Polylactide Homopolymers, Copolymers, and Blends - In Vitro Degradation Tests
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YY/T 0509-2009
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