ISO/TC 150/SC 1/WG 5 - Plastics

This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms or forms fabricated for use in the manufacture of surgical implants.

This document specifies the requirements and corresponding test methods for ultra-high-molecular-weight polyethylene (UHMWPE) powder moulding materials for use in the manufacturing of moulded forms that are subsequently used in the manufacturing of surgical implants. This document is not applicable to UHMWPE moulding materials that were blended with any additives or different forms of polyethylene.

This document specifies the test method for assessing the morphology of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as defined in ISO 5834-2. The assessment of morphology of UHMWPE moulded forms is not required in routine monitoring of validated moulding process because alternative test methods defined in ISO 5834-2, such as density and mechanical properties, already provide reasonable, redundant assurance of successful consolidation. This document is not applicable to UHMWPE powder forms, which are described in ISO 5834-1. NOTE Performance requirements for this test method have not been established.

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of specimens taken from UHMWPE moulded forms or forms fabricated from these for use in the manufacture of surgical implants. The specimens are aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

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.