\\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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Animal welfare requirements Status: We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.
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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.
Activation of monitoring failed – please try again later or contact us. 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.
Search all products by. Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. You may experience issues viewing this site in Internet Explorer 9, 10 or The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. It is not possible to buy in the shop – please contact us.
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ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements
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.
TC Wrap Up Dec 13, Continue shopping Proceed to checkout. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. Iao outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Please choose number of 10993-22 you want to open the document on. Click to learn more. Biological evaluation of medical devices – Part 2: ISO does not deal well with biological evaluation of respiratory devices — such as ventilators, masks and inhalers — which have indirect patient contact via the gas pathway.
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Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions. December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again iao.
New content on postmarket monitoring and electronic records. An annex on risk management. lso
Pass fail criteria have now been deleted from the current draft, although there has been new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods. ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation.
Part 18 was substantially revised and is now isoo to be converted from a Technical Specification to a full standard. Du abonnerer allerede dette emne.