GSO ISO 13781:2016
ISO 13781:1997
Gulf Standard
Current Edition
·
Approved on
22 December 2016
Poly(L-lactide) resins and fabricated forms for surgical implants -- In vitro degradation testing
GSO ISO 13781:2016 Files
English
9 Pages
Current Edition
Reference Language
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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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