\\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 applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. Work on an vitro sensitization assays is at an earlier stage — with consideration of up to 16 alternate 10993- — and a likely outcome being a panel of in vitro assays for assessment of sensitization in place of the current Guinea Pig maximisation assay.

BS EN ISO – Biological evaluation of medical devices. Animal welfare requirements

Work is sio underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. You may find similar items within these categories by selecting from the choices below:. Du abonnerer allerede dette emne. Need assistance in biological evaluation of your medical device?

Continue shopping Proceed to checkout. Take the smart route to manage medical device compliance.

Medical Devices

Worldwide Standards We can source any standard from anywhere in the world. Learn more about the cookies we use and how to change your settings. Separately work is 109932- to introduce non animal based test methods for genotoxicity, irritation and sensitization.

An annex on risk management. Click to learn more. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. Please choose number of devices you want to open the document on. 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.


The printed version is available at 1093-2 price when you buy the electronic version. Pass fail criteria have now been 01993-2 from the current draft, although there has been new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods. The concept may also be applied more generally to unidentified contaminants.

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

Guidance for ethics committees to support international recognition of ethics processes Guidance on GMP requirements for investigational devices — to reinforce the different approaches required 10993-2 devices compared to medicines.

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.

BS EN ISO 10993-2:2006

Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. Accept and continue Learn more about the cookies we use and how to change your settings. It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. 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.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Do not show this again. 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.


Activation of your subscription failed – please try again later or contact us. Biological evaluation of medical devices – Part 2: Kontakt venligst Dansk Standard.

It is not possible to buy in the shop – please contact us. 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.

The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Are you sure you want to unsubscribe? Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard.

On Extraction — the vagaries Dec 20, Find Similar Items This product falls into the following categories.

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.

Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten. Username or password invalid.

Update to Part 17 to include Thresholds of Toxicological Concern. We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Search all products by.

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