OS GSO ISO 13781:2016

ISO 13781:1997
Omani Standard   Current Edition · Approved on 22 December 2016

Poly(L-lactide) resins and fabricated forms for surgical implants -- In vitro degradation testing

OS GSO ISO 13781:2016 Files

English 9 Pages
Current Edition Reference Language
OMR 30.98

OS GSO ISO 13781:2016 Scope

This International Standard describes methods for the determination of chemical and mechanical changes in properties of poly(L-lactide) under in vitro degradation testing conditions. The purpose of this International Standard is to compare and/or evaluate materials or processing conditions. This International Standard applies to poly(L-lactide) in various forms, used for the manufacture of surgical implants, including: a) bulk material; b) processed material; c) finished products (packaged and sterilized implants). The test methods specified in this International Standard are intended to determine the degradation rate and the changes in material properties of poly(L-lactide) in vitro. These in vitro methods cannot be used to predict definitely the behaviour under in vivo conditions. NOTE — It is recommended that copolymers and/or blends from poly(l-lactide) and/or its stereoisomers also be tested according to this International Standard as long as no relevant International Standard is available.

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