19/30372368 DC - BS EN ISO 10993-23. Biological evaluation of medical devices. Part 23. Tests for irritation

19/30372368 DC

BS EN ISO 10993-23. Biological evaluation of medical devices. Part 23. Tests for irritation

Status : Current, Draft for public comment   Published : May 2019

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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-12.

This document includes:

  • pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

  • details of in vitro and in vivo irritation test procedures;

  • key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex D several special in vivo irritation tests are described for application of medical devices in areas other than skin. In addition, Annex E provides information for conducting human skin irritation testing.




Standard Number19/30372368 DC
TitleBS EN ISO 10993-23. Biological evaluation of medical devices. Part 23. Tests for irritation
StatusCurrent, Draft for public comment
Publication Date13 May 2019
Normative References(Required to achieve compliance to this standard)ISO 10993-15, ISO 14155, ISO 10993-18, ISO 10993-14, ISO 10993-13, ISO 10993-1, ISO 10993-12, ISO 10993-2, ISO 10993-9
Informative References(Provided for Information)ISO 9394:2012
International RelationshipsEN ISO 10993-23:2019
Draft Expiry Date01 July 2019
DescriptorsHuman body, Biological analysis and testing, Medical equipment, Evaluation, Biological tests
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux Partie 23: Essais d'irritation
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages74
File Size870 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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