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

Activation of your subscription failed – please try again later or contact us. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical 19093-2. Biological evaluation of medical devices – Part 2: Activation of monitoring failed – please try again later or contact us.

Are you sure you want to unsubscribe monitoring? The concept may also be applied more generally to unidentified contaminants. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. Nanomaterials, EO residues, hemolysis and more.

May 9, admin. The current approaches in Part 1 set out requirements which were really intended for indirect 1099-32 contact devices such as infusion equipment.

BS EN ISO 10993-2:2006

There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard. Oso download Chrome or Firefox or view our browser tips. Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. The outcome was addition of MEM elution test to the Annex of the revision draft.

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. Click to learn more. Are you sure 10939-2 want to unsubscribe?

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

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.

Guidance for ethics committees to support international recognition of ethics processes Guidance on 10993-2 requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines. Pass fail criteria have now been deleted from the current draft, although there has 110993-2 new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods.

Medical Devices

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ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. Search all products by.

iwo We use cookies to make our website easier to use and to better understand your needs. 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.

ISO – Wikipedia

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

The printed version is available at half price when you buy the electronic version. Worldwide Standards We can source any standard from anywhere in the world. 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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It also makes recommendations and offers 100993-2 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. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine jso.

Please choose number of devices you want to open the document on. A major revision of Part 17 on allowable limits for leachables is in the works.

You may 19093-2 similar items within these categories by selecting from the choices below:. 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.

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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.

New content on postmarket monitoring and electronic records. December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products. Du abonnerer allerede dette emne. On Extraction — the vagaries Dec 20,