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ISO 13781

Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing

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Organization: ISO
Publication Date: 1 February 1997
Status: inactive
Page Count: 12
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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.

Document History

July 1, 2017
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
This document describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing...
ISO 13781
February 1, 1997
Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing
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...
February 1, 1997
Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing
A description is not available for this item.

References

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