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

Standard No.

GB/T 16886.19-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 16886.19-2022

Replace

GB/T 16886.19-2011

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 intended use of the medical device (clinical application and duration of use), even if such performance coincides with clinical effectiveness. This document applies to final medical device materials. This document does not apply to the qualitative or quantitative determination of degradation products, nor does it apply to the evaluation of the physical and chemical properties of degraded materials. See ISO 10993 9, ISO 10993 13, ISO 10993 14, and ISO 10993 15 for relevant content. See ISO 10993 18 for chemical characterization of materials. GB/T(Z)16886 (all parts) does not apply to medical devices and materials that have no direct or indirect contact with the human body.

GB/T 16886.19-2022 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

GB/T 16886.19-2022 history

• 2022 GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
• 2011 GB/T 16886.19-2011 Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials

GB/T 16886.19-2022 -All Parts