20/30377819 DC - BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization

20/30377819 DC

BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization

Status : Current, Draft for public comment   Published : February 2020

Format
PDF

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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 induce skin sensitization.

This document includes:

  • details of in vivo sensitization test procedures;

  • key factors for the interpretation of the results.

NOTE

Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.




Standard Number20/30377819 DC
TitleBS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization
StatusCurrent, Draft for public comment
Publication Date17 February 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-13, ISO 10993-9, ISO 10993-15, ISO 10993-18, ISO 10993-12, ISO 10993-2, ISO 10993-14, ISO 14155, ISO 10993-1:2018
Informative References(Provided for Information)ASTM F2148-13
International RelationshipsISO/DIS 10993-10
Draft Expiry Date08 April 2020
DescriptorsSkin (body), Bioassay, Human biology, Biological analysis and testing, Human body, Medical equipment, Allergies, Laboratory animals
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux — Partie 10: Essais de sensibilisation cutanée Partie 10: Essais de sensibilisation cutanée
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages61
File Size883 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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