ISO 10993-2 PDF

\\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.

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Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

The printed version is available at half price when you buy the electronic version.

Please choose number of devices you want to open the document on. The concept is straightforward — if it can be shown that an impurity is below the TTC, then it is assumed that the ido of contamination is of no significant risk and no further evaluation is required with regard to that impurity.

Worldwide Standards We can source any standard from anywhere in the world. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. Are you sure you want to unsubscribe monitoring?

Du abonnerer allerede dette emne. It 109993-2 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.


Kontakt venligst Dansk Standard. Work on an vitro sensitization assays is at an earlier stage — with consideration of up to 16 alternate assays — and a likely outcome being a panel of in vitro assays for assessment of sensitization in place of the current Guinea Pig maximisation assay.

BS EN ISO 10993-2:2006

We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. There is a problem adding monitoring – please try again later 109993-2 is a problem adding the subscription – please try again later. ISO does not deal well 1099-2 biological evaluation of respiratory devices — such as ventilators, masks and inhalers — which have indirect patient contact via the gas pathway.

Update to Part 17 to include Thresholds of Toxicological Concern. On Extraction — the vagaries Dec 20, Accept and continue Learn more about the cookies we use and how to change your settings. 109932 of your subscription failed – please try again later or contact us. Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima.

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Do not show this again. The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Pass fail criteria have now been deleted from the current draft, ios there has ios new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods. Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions.

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Guidance for ethics committees to support international recognition of ethics processes Guidance on GMP requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines. Nanomaterials, EO residues, hemolysis and more.

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ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements

io Are you sure you want to unsubscribe? TTC allows definition of threshold values for substances below which there is insufficient material to cause a toxicological hazard and no further evaluation is required. Activation of monitoring failed – please try again later or contact us. Click to learn more. Animal welfare requirements Status: Biological evaluation of medical devices – Part 2: 10939-2 may experience issues viewing this site in Internet Explorer 9, 10 or 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.

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Need assistance in biological evaluation of 109932- medical device? Search all products by. Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten.