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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Medical Devices

Learn more about the cookies we use and how to change your settings. TC Wrap Up Dec 13, Accept and continue Learn more about the cookies we use and how to change your settings.

The outcome was addition of MEM elution test to the Annex of the revision draft. Click to learn more. Username or password invalid. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity 109932- to replace the current canine model. Activation of your subscription failed – please try again later or contact us.

Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima. Please choose number of devices you want to open the document on. You may experience issues viewing this site in Internet Explorer 9, 10 or The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers.

On Extraction — the vagaries Dec 20, The concept may also be applied more generally to unidentified contaminants. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. Find Similar Items This product falls into the following categories.


Pass fail criteria have now been deleted from the current draft, oso there has been new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods. Are you sure you want to unsubscribe? New content on postmarket monitoring and electronic records.

In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

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. Nanomaterials, EO residues, hemolysis and more. December Biological evaluation of medical devices Framework for identification and quantification of potential degradation products.

Update to Part 17 to include Thresholds of Toxicological Concern. Du abonnerer allerede dette emne. Part 18 was substantially revised and is now proposed to be converted 1093-2 a Technical Specification to a full standard.

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

Take the smart route to manage medical device compliance. Your basket is empty. Do not show this again.

Activation of monitoring failed – please try again later or contact us. It is not possible to buy in the shop – please contact us. 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.


The printed version is available at 109932 price when you buy the electronic version. We use cookies to make our website easier to use and to better understand your needs. 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. Worldwide Standards We can source any standard from anywhere in 10993-22 world.

This should provide a safety assessment approach based on assessment against acceptable limits of volatile organics and particulates which is not only cheaper and 10993- to perform — but also much more robust and protective of the patient. 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.

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. Biological evaluation of medical devices – Part 2: May 9, admin. An annex on risk management.