BIOLOGICAL EVALUATION OF MEDICAL DEVICES — PART 18: CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE MATERIALS WITHIN A RISK MANAGEMENT PROCESS

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Edition	2020
Standard Part No	18
Published Date	2020
Published By	International Standardization Organisation
Page Count	66

ISO

ISO 10993 5:2009

ISO 10993 3:2014

ISO 10993 10:2010

ISO 10993 12:2012

ISO 10993 11:2017

ISO 10993 1:2018

ISO 10993 18:2020

ISO 10993-1:1992

ISO 11040-6:2019

ISO 11058:2019

ISO 11064 3:1999

ISO 11064 2:2000