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

New content on postmarket monitoring and electronic records. 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.

The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers.

Take the smart route to manage medical device compliance. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. A major revision of Part 17 on allowable limits for leachables is in the works.

Please download Chrome or Firefox or view our browser tips. Accept and continue Learn more about the cookies we use and how to change your settings. Guidance for ethics committees to support international recognition of ethics 10993-2 Guidance 109932 GMP requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines. Exigences relatives a la protection des animaux Title in German Biologische Beurteilung von Medizinprodukten.


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

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.

An annex on risk management. Biological evaluation of medical devices – Part 2: The printed version is available at half 109993-2 when you buy the electronic version. The outcome was addition of MEM elution test to the Annex of the revision draft. Nanomaterials, EO residues, hemolysis and more.

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

It is not possible to buy in the shop – please contact us. Your basket is empty. Part sio was substantially revised and is now proposed to be converted from a Technical Specification to a full standard. Animal welfare requirements 1093-2 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.

You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later. Update to Part 17 19093-2 include Thresholds of Toxicological Concern. Are you sure you want to unsubscribe? Need assistance in biological evaluation of your medical device?


We can help you with developing your evaluation strategy, 10939-2 with test laboratories and preparation of expert reports. Continue shopping Proceed to checkout.

This should provide a safety assessment approach based on assessment against acceptable limits isp volatile organics and particulates which is not only cheaper and simpler to perform — but also much more robust and protective of the patient.

Medical Devices

Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. 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. Kontakt venligst Dansk Standard. Pass fail criteria have now isoo deleted from the current draft, although there has been new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods.

In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. Scope This part of ISO is aimed at those who commission, design and perform tests or evaluate 10993–2 from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical iao themselves. Click to learn more.