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 | VUOS a.s.

The printed 10993-22 is available at half price when you buy the electronic version. It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. In the is anniversary meeting of TC some substantial revisions to the current ISO series were made.

The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later.

Nanomaterials, EO residues, hemolysis and more. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

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.


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

Your basket is empty. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. 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.

May 9, admin. An annex on ido management.

Medical Devices

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. 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.

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. TC Wrap Up Dec 13, Du abonnerer allerede dette emne.

BS EN ISO 10993-2:2006

Biological evaluation of medical devices – Part 2: On Extraction — the vagaries Dec 20, We use cookies to make our website easier to use and to better isoo your needs. Take the smart route to manage medical device compliance. Activation of monitoring failed – please try again later or contact us.


The concept may also be applied more generally to unidentified contaminants. It is not possible to buy in the shop – please contact us. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. Kontakt venligst Dansk Standard.

ISO – Wikipedia

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. A major revision of Part 17 on allowable limits for leachables is in the works.

December 01993-2 evaluation of medical devices Framework for identification and quantification of potential degradation products. 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.

Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. Are you sure you want to unsubscribe monitoring? Arthur Brandwood has been involved as an Australian expert member of TC since and was present in Mishima.

Update to Part 17 to include Thresholds of Toxicological Concern. Click to learn more. Worldwide Standards We can source any standard from anywhere in the world.