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  • BSI
    BS EN ISO 10993-18:2020 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
    Edition: 2020
    $530.41
    / user per year

Description of BS EN ISO 10993-18:2020 2020

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.



Standard NumberBS EN ISO 10993-18:2020
TitleBiological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
StatusWithdrawn
Publication Date2020-12-14
Withdrawn Date2023-07-27
ReplacesBS EN ISO 10993-18:2009
Identical National Standard OfISO 10993-18:2020, EN ISO 10993-18:2020
CorrectsBS EN ISO 10993-18:2020
DescriptorsMedical equipment, Chemical analysis and testing, Ceramics, Biological analysis and testing, Chemical composition, Safety measures, Polymers, Identification methods, Chemical properties, Alloys, Equipment safety, Quality assurance, Health and safety requirements, Conformity, Metals
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 539 16358 2
PublisherBSI
Pages84

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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