\\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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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.
New content on postmarket monitoring and electronic records.
Need assistance in biological evaluation of your medical device? Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions.
In the 25th anniversary meeting of TC isk substantial revisions to the current ISO series were made. Are you sure you want to unsubscribe?
Work is also underway on a new Annex on complement testing possible 10993-2 vitro thrombogenicity models to replace the current canine model. Activation of monitoring failed – please try again later or contact us. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard. You may experience issues viewing this site in Internet Explorer 9, 10 or It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you isl logged in.
The outcome was addition of MEM elution test to the Annex of the revision draft.
BS EN ISO 10993-2:2006
Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten. Please choose number of devices you want to open the document on. Nanomaterials, EO residues, hemolysis and more. A major revision of Part 17 on allowable limits for leachables is in the works.
December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products. Username or password invalid. Are you sure you want to unsubscribe monitoring? Find Similar Items This product falls into the following categories. We use iao to make our website easier to use and to 1993-2 understand your needs. 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.
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Medical Devices | VUOS a.s.
10939-2 venligst Dansk Standard. May 9, admin. TC Wrap Up Dec 13, An annex on risk management. On Extraction — the vagaries Dec 20, Ieo evaluation of medical devices – Part 2: Update to Part 17 to include Thresholds of Toxicological Concern.
You may find similar items within these categories by selecting from the choices below:. 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. 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.
Accept and continue Learn more about the cookies we use and how to change your settings. Do not show this again. Continue shopping Proceed to checkout. Du abonnerer allerede dette emne. Animal welfare requirements Status: We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives.
BS EN ISO – Biological evaluation of medical devices. Animal welfare requirements
This website is iao viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The concept may also be applied more generally to unidentified contaminants. Separately work is underway to introduce isso animal based test methods for genotoxicity, irritation and sensitization. Click to learn more. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. It is not possible to buy in the shop – please 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.
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. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. 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.
This should provide a safety assessment approach based on assessment against acceptable limits of volatile ido and particulates which is not only cheaper and simpler to perform — but also much more robust and protective of the patient. Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima.