GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process

Scope

This document specifies the framework for the qualitative and quantitative (if necessary) identification of the components of medical devices, as well as the identification of biological hazards (sources) of material components and their biological risk assessment and control through progressive chemical characterization.
This document applies to one or more of the following:
——The qualitative identification of the manufacturing materials (structure of medical devices);
——The characterization of the manufacturing materials through qualitative and quantitative analysis of their chemical components (material composition);
——The characterization of chemical substances introduced into medical devices during the manufacturing process (e.g., mold release agents, process contaminants, sterilization residues);
——The estimation of the potential for chemical substances to be released from medical devices or their manufacturing materials under clinical use conditions (using laboratory extraction conditions) (extractables);
——The determination of the chemical substances released from medical devices under clinical use conditions (leachables).
This document also applies to the chemical characterization of degradation products (e.g., qualitative and/or quantitative). ISO 10993-9, ISO 10993-13, ISO 10993- 14, and ISO 10993- 15 cover information on other aspects of degradation evaluation.
GB/T(Z) 16886 (all parts) applies to materials or medical devices that come into direct or indirect contact with the human body (see ISO 10993-1 "Classification according to the nature of human contact").
This document is intended to provide biological evaluation support for material suppliers and medical device manufacturers.

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