20/30398724 DC - BS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements

20/30398724 DC

BS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements

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

Format
PDF

Format
HARDCOPY



This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity of the data. This document is for those who commission, design and perform testing or evaluate the data to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.

This document makes recommendations and offers guidance intended to facilitate further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.




Standard Number20/30398724 DC
TitleBS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements
StatusCurrent, Draft for public comment
Publication Date17 February 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-1:2018
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsISO/DIS 10993-2
Draft Expiry Date07 April 2020
DescriptorsLaboratory techniques, Animals, Personnel, Test specimens, Surgery, Medical equipment, Laboratory testing, Biological analysis and testing, Laboratory workers, Laboratory animals, Animal welfare, Planning, Testing conditions
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux — Partie 2: Exigences relatives à la protection des animaux Partie 2: Exigences relatives à la protection des animaux
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages25
File Size434 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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