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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Your basket 01993-2 empty. The printed version is available at half price when you buy the electronic version. Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima. Worldwide Standards We can source any standard from anywhere in the world.

Biological evaluation of medical devices – Part 2: Are you sure you want to unsubscribe monitoring? You may find similar items within these categories by selecting from the choices below:.

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. May 9, admin. 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.

ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements

Nanomaterials, EO residues, hemolysis and more. Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions. This should provide isp 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. lso

BS EN ISO 10993-2:2006

Take the smart route to manage medical device compliance. The outcome was addition of MEM elution test to the Annex of the revision draft.

Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. 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 is of no significant risk and no further evaluation is required with regard to that impurity.


A major revision of Part 17 on allowable limits for leachables is in the works. Are you sure you want to unsubscribe? 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. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription.

TC Wrap Up Dec 13, Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. 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.

An annex on risk management. Click to learn more. Username or password invalid. Please download Chrome or Firefox or view our browser tips. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard. 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.

In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

On Extraction — the vagaries Dec 20, ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation.

Activation of monitoring failed – please try again later or contact us. 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. 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.


The concept may also be applied more generally to unidentified contaminants.

Find Similar Items This product falls into the following categories. 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 are logged in. Do not show this again. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. Animal welfare requirements Status: It is not possible to buy in the shop – please contact us.

Work is also underway on a 19093-2 Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten.

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.

Please choose number of devices you want to open the document on. The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. This website is best 109993-2 with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

New io on postmarket monitoring and electronic records. December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products.

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.

Medical Devices | VUOS a.s.

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