<p>ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under <i>in vitro</i> degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.</p>
<p>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 <i>in vitro</i> degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.</p>
<p>ISO 13781:2017 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).</p>
<p>The test methods specified in this document are also intended to determine the <i>in vitro</i> 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 <i>in vitro</i> methods cannot be used to definitively predict device behaviour under <i>in vivo</i> conditions.</p>
Registration number (WIID)
64565
Scope
<p>ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under <i>in vitro</i> degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.</p>
<p>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 <i>in vitro</i> degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.</p>
<p>ISO 13781:2017 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).</p>
<p>The test methods specified in this document are also intended to determine the <i>in vitro</i> 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 <i>in vitro</i> methods cannot be used to definitively predict device behaviour under <i>in vivo</i> conditions.</p>
