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ISO - 10993-18

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

active, Most Current
Organization: ISO
Publication Date: 1 January 2020
Status: active
Page Count: 74
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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.

Document History

10993-18
January 1, 2020
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...
July 1, 2005
Biological evaluation of medical devices Part 18: Chemical characterization of materials
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information...

References

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