GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

Scope

This document specifies various parameters and test methods that can be used to identify and evaluate the physical properties of final medical device materials, such as physicochemical, morphological, and surface properties (PMT). This evaluation is limited to performance related to biological evaluation and the intended use of medical devices (clinical applications and usage time), even if such performance coincides with clinical effectiveness. This document applies to final medical device materials. It does not apply to the qualitative or quantitative determination of degradation products, nor to the evaluation of the physicochemical properties of degraded materials. For these aspects, refer to ISO 109939, ISO 1099313, ISO 1099314, and ISO 1099315. For material chemical characterization, refer to ISO 1099318. GB/T (Z) 16886 (all parts) does not apply to medical devices and materials that do not come into direct or indirect contact with the human body.

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