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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An annex on risk management.

A major revision of Part 17 on allowable limits for leachables is in the works. Please choose number of devices you want to open the document on. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard.

Continue shopping Proceed to checkout. 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 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.

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Medical Devices | VUOS a.s.

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Username or password invalid. December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products.

Animal welfare requirements Status: Take the smart route to manage medical device compliance. 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.

It is not possible to buy in the shop – please contact us. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. Activation of monitoring failed – please try again later or contact us.


Your basket is empty. Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten. You may find similar items within these categories by selecting from the choices below:.

Nanomaterials, EO residues, hemolysis and more. 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. You may experience issues viewing this site in Internet Explorer 9, 10 or 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.

Are you sure you want to unsubscribe monitoring? Click to learn more. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.

Biological evaluation of medical devices – Part 2: Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

Du abonnerer allerede dette emne. The outcome was addition of MEM elution test to the Annex of the revision draft. Accept and continue Learn more about the cookies we use and how to change your settings. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

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. The printed version is available at half price when you buy the electronic version.


On Extraction — the vagaries Dec 20, We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Update to Part 17 to include Thresholds iao Toxicological Concern.

BS EN ISO 10993-2:2006

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 109933-2 euthanised.

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 1993-2 anniversary meeting of TC some substantial revisions to the current ISO series were made. 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.

New content on postmarket monitoring and electronic records. The concept may also be applied more generally to unidentified contaminants.

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Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. May 9, admin. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment.