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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.20 Biological evaluation of medical devices>BS EN ISO 10993-18:2020 Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
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immediate downloadReleased: 2020-12-14
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process

BS EN ISO 10993-18:2020

Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process

CURRENCY
LANGUAGE
English
Standard number:BS EN ISO 10993-18:2020
Pages:84
Released:2020-12-14
ISBN:978 0 539 16358 2
Status:Corrigendum
DESCRIPTION
This standard BS EN ISO 10993-18:2020 Biological evaluation of medical devices is classified in these ICS categories:
  • 11.100.20 Biological evaluation of medical devices

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.


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