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YY/T 0474-2004 English PDF

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YY/T 0474-2004: Poly (L-lactide) resins and fabricated forms for surgical implants. In vitro degradation testing
Status: Valid
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YY/T 0474-2004English299 Add to Cart 3 days [Need to translate] Poly (L-lactide) resins and fabricated forms for surgical implants. In vitro degradation testing Valid YY/T 0474-2004

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Basic data

Standard ID YY/T 0474-2004 (YY/T0474-2004)
Description (Translated English) Poly (L-lactide) resins and fabricated forms for surgical implants. 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 11,180
Date of Issue 2004-03-23
Date of Implementation 2005-01-01
Adopted Standard ISO 13781-1997, MOD
Regulation (derived from) SFDA [2004] No. 86
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the poly-L-lactide in vitro degradation test chemical or mechanical properties under conditions change method. The purpose of this standard is to compare and (or) evaluation materials or processing conditions. This standard applies to the production figures surgical implant various forms of poly-L-lactide. Include: a) bulk, b) processing materials, c) the final product (after packaging and sterilization of implants. ] As specified in this standard test method for the determination of poly-L-lactide and materials in vitro degradation rate changes in performance of these in vitro test methods can not be used to predict the exact material behavior under in vivo conditions.

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