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

Standard No.

GB/T 16886.18-2022

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 16886.18-2022

Replace

GB/T 16886.18-2011

Scope

This document specifies the qualitative and quantitative (if necessary) framework for medical device components, the identification of biological hazards (sources) of material components and their biological risk assessment and control through progressive chemical characterization. This document is applicable to one or more of the following: --- the characterization of its manufacturing materials (medical device construction); --- the characterization of the manufacturing materials by qualitative and quantitative material chemical composition (material composition); --- Characterization of chemical substances introduced during the manufacturing process of medical devices (such as release agents, process contaminants, sterilization residues); --- the possibility of releasing chemical substances from medical devices or their manufacturing materials under clinical use conditions Estimation (using laboratory extraction conditions) (extractables); version——determination of chemical substances released by medical devices under their clinical use conditions (leachables). This document is also applicable to the chemical characterization (e.g. qualitative and/or quantitative) of degradation products. ISO 10993 9, ISO 10993 13, quasi-ISO 10993 14 and ISO 10993 15 cover other aspects of degradation evaluation. The national standard GB/T(Z) 16886 (all parts) applies to materials or medical devices that come into direct or indirect contact with the human body (see ISO10993 1 "Classification according to the nature of human body contact"). This document is intended to support biological evaluation for material suppliers and medical device manufacturers.

GB/T 16886.18-2022 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14971 Medical devices - Application of risk management to medical devices

GB/T 16886.18-2022 history

• 2022 GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
• 2011 GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials

GB/T 16886.18-2022 -All Parts