ISO 13781:2017
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ISO 13781:2017
64565
Indisponible en français

État actuel : Publiée (En cours d'examen)

Le dernier examen de cette norme date de 2023. Cette édition reste donc d’actualité.
fr
Format Langue
std 1 96 PDF + ePub
std 2 96 Papier
  • CHF96
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Résumé

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.

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).

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.

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Informations générales

  •  : Publiée
     : 2017-07
    : Norme internationale confirmée [90.93]
  •  : 2
  • ISO/TC 150/SC 1
    11.040.40 
  • RSS mises à jour

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