\\FS09\USER\RUF\ISO\TC \normen\\Revision \EN_ISO_ 2_(E) This document is not an ISO International Standard. Purchase your copy of BS EN ISO as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards. ISO. /(R) Biological evaluation of medical devices — Part 2: Animal welfare requirements. American. National. Standard.
|Published (Last):||12 November 2013|
|PDF File Size:||20.48 Mb|
|ePub File Size:||14.85 Mb|
|Price:||Free* [*Free Regsitration Required]|
FCR – First Clinical Research Laws, Regulations & Guidelines
Biological evaluation of medical devices – Part 2: Continue shopping Proceed to checkout. Scope This part of ISO is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical devices themselves.
It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
It also makes recommendations and offers guidance intended to facilitate future 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. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It 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 euthanised.
Do not show this again. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription.
There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later. Du abonnerer allerede dette emne.
Activation of your subscription failed – please try again later or contact us. Activation of monitoring failed – please try again later or contact us. Are you sure you want to unsubscribe monitoring?
Are you sure you want to 109932- It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. Kontakt venligst Dansk Standard.
BS EN ISO – Biological evaluation of medical devices. Animal welfare requirements
Username or password invalid. Please choose number of devices you want to open the document on.
The printed version is available at half price when you buy the electronic version. It is not possible to buy in the shop – please contact us.