\\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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You may experience issues viewing this site in Internet Explorer 9, 10 or New content on postmarket monitoring and electronic records. Kontakt venligst Dansk Standard. Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten.
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. 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.
Find Similar Items This product falls into the following categories. It is not possible to buy in the shop – please contact us. The concept is straightforward — if it can be shown that an impurity is below the TTC, then it is assumed that the level of contamination izo of no significant risk and no further evaluation is required with regard to that impurity.
The outcome was addition of MEM elution test to the Annex of the revision draft. The printed version is available at half price when you buy the electronic version.
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Worldwide Standards We can source any standard from anywhere in the world. It was not possible to unsubscribe – please try again later isl contact the Danish Standard Please make sure you are logged in. Continue shopping Proceed to checkout. Biological evaluation of medical devices – Part 2: December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products. You may find similar items within these categories by selecting from the choices below:.
Separately work is underway to introduce non animal 1099-2 test methods for genotoxicity, irritation and sensitization.
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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. Activation of monitoring failed – please try again later or contact us. Username or password invalid.
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In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. Animals, Animal 109932- Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, 1093-2 testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. Nanomaterials, EO residues, hemolysis and more. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. It 10993- the minimum requirements to be satisfied to ensure ieo 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.
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TC Wrap Up Dec 13, It does not apply to tests performed on invertebrate animals and 1993-2 lower forms; nor other than with respect to provisions relating to isl, source, health status, and care and accommodation does it apply to testing uso on isolated tissues and organs taken from vertebrate animals that have been euthanised. The concept may also be applied more generally to unidentified contaminants.
Are you sure you want to unsubscribe? Your basket is empty. Guidance for ethics committees to support international recognition of ethics processes Guidance on Uso requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines.
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.
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 109993-2 of materials intended for use in medical devices, or of the medical devices themselves. 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.
Update to Part 17 to include Thresholds of Toxicological Concern.
May 9, admin. A major revision of Part 17 on allowable limits for leachables is in the works. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 ido Firefox 3.
Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. Accept and continue Learn 01993-2 about the cookies we use and how to change your settings. Please download Chrome or Firefox or view our browser tips.