BS ISO 13781:2017 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 conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.

The purpose of this document is to compare and/or evaluate materials or processing conditions. This document also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.

This document is applicable to poly(lactide)-based homopolymers, copolymers and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants).

The test methods specified in this document are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.


Cross References:
ISO 178:2010 Ed 5
ISO 14130:1997
ISO 1805:2006 (R10) Ed 2
ISO 16014-1:2012
ASTM F1635 - 16
ISO 1628-1:2009 Ed 3
ISO 16014-5:2012
ISO 604:2002
ISO 13934-1:2013 ED2
ASTM D2990 - 17
ISO 527-1:2012
ISO 16014-2:2012
ISO 2062:2009 Ed 3
ISO 6721-2:2008 Ed 2
ASTM D5296 - 11
ISO 16014-4:2012
ASTM F2902 - 16e1
ISO 16014-3:2012
ISO 527-3:1995 (R10)
ISO 527-2:2012
ISO 180:2000 USP<1251>
DIN 12448:1977 (Eng Trans)
ASTM E284 - 13a
ASTM D4001 - 13
ISO 3146:2000 Ed 3 (R10)
ISO 3696:1987
ASTM D4475 - 02(2016)


All current amendments available at time of purchase are included with the purchase of this document.