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YY/T 0473-2004 PDF English

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YY/T 0473-2004: Implants for surgery. Copolymers and blends based on polylactide. In vitro degradation testing
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YY/T 0473-2004English299 Add to Cart 3 days [Need to translate] Implants for surgery. Copolymers and blends based on polylactide. In vitro degradation testing

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Basic data

Standard ID YY/T 0473-2004 (YY/T0473-2004)
Description (Translated English) Implants for surgery. Copolymers and blends based on polylactide. In vitro degradation testing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.40
Word Count Estimation 11,122
Date of Issue 2004-03-23
Date of Implementation 2005-01-01
Adopted Standard ISO 15814-1999, MOD
Regulation (derived from) SFDA [2004] No. 86
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to the production of surgical implants polylactide copolymer and (or) the bulk blends or processed wood. This standard specifies the conditions determined in vitro degradation of these copolymers and (or) blends chemistry and (or) changes in mechanical properties. Specified in this standard test method for measuring in vitro with different comonomer (such as glycolide, trimethylene carbonate, ��-L lactone) polylactide-based copolymers, and (or) of the degradation rate of blends and material properties changes. These in vitro test methods can not be used to accurately predict material behavior under in vivo conditions. This standard applies to compare and (or) evaluation materials or processing conditions.

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