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. Kontakt venligst Dansk Standard. Nanomaterials, EO residues, hemolysis and more. May 9, admin. You may find similar items within these categories by selecting from the choices below:.

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.

Are you sure you want to unsubscribe? Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima.

FCR – First Clinical Research Laws, Regulations & Guidelines

It is 100993-2 possible to buy in the shop – please contact us. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or 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 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.


TC Wrap Up Dec 13, 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. Accept and continue Learn more about the cookies iiso use and how to change your settings. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later.

Du abonnerer allerede dette emne. Lso 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. The printed version is available at half price when you buy the electronic version.

ISO – Wikipedia

On Extraction — the vagaries Dec 20, 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. Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions.

We can help you with developing isso evaluation strategy, dealing with test laboratories and preparation of expert reports. Take the smart route to manage medical device compliance.

An annex on risk management. The concept may also be applied more generally to unidentified contaminants. Animal assays will be with isso for a while yet — but TC is making real progress on non-animal alternatives. Username or password invalid.


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Search all products by. Need assistance in biological evaluation of your medical device?

Please choose number of devices you want to open the document on. Worldwide Standards We can source any standard from anywhere in the world. A major revision of Part 17 on allowable limits for leachables is in the works.

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BS EN ISO 10993-2:2006

The outcome was addition of MEM elution test to the Annex of the revision draft. 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.

Your basket is empty. You may experience issues viewing this site in Internet Explorer 9, 10 or Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

Activation of monitoring failed – please try again later or contact us. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

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