\\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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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.

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. We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.

It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation.

Nanomaterials, EO residues, hemolysis and more. Animal welfare requirements Status: Update to Part 17 to include Thresholds of Toxicological Concern. The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Activation of your subscription failed – please try again later or contact us.

Take the smart route to manage medical device compliance. 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.


We use cookies to make our website easier to use and to better understand your needs. Are you sure you want to unsubscribe? Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima. Please download Chrome or Firefox or view our browser tips.

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Medical Devices

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. This should provide a safety assessment approach based on assessment against acceptable limits of volatile organics and particulates which is not only cheaper and simpler to perform — but also much more robust and protective of the patient.

Ido abonnerer allerede dette emne. The concept is straightforward 109993-2 if it can be shown that an impurity is below the TTC, then it is assumed that the level of contamination is of no significant risk and no further evaluation is required with regard to that impurity. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Username or password invalid. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. Biological evaluation of medical devices – Part 2: 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.


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109932- assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. You may experience issues viewing this site in Internet Explorer 9, 10 or 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 109932.

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In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later. Your ios is empty.

Activation of monitoring failed – please try again later or contact us. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

Last modified: September 2, 2020