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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Medical Devices | VUOS a.s.

December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products. Are you sure you want to unsubscribe?

Need assistance in biological evaluation of your medical device? 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. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard.

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It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment.

Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions. 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.


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. Update to Part 17 to include Thresholds of Toxicological Concern. 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.

Continue shopping Proceed to checkout. Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization.

It is not possible to buy in the shop – please contact us. You may experience issues viewing this site in Internet Explorer 9, 10 or Guidance for ethics committees iao support international recognition of ethics processes Guidance on GMP requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines.

A major revision of Part 17 on allowable limits for leachables is in the works.

Medical Devices

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Search all products by. Animal welfare requirements Status: The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Arthur Brandwood has been involved as an Australian expert 109993-2 of TC since and was present in Mishima. Exigences relatives ieo la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten. You may find similar items within these categories by selecting from the choices below:.

It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

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Take the smart route to manage medical device compliance. TC Wrap Up Dec 13, Scope This 10993–2 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. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation. Worldwide Standards We can source any standard lso anywhere in the world.