\\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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Take the smart route to manage medical device compliance.
An annex on risk management. This should provide a safety assessment approach based on assessment against acceptable limits of isi organics and particulates which is not only cheaper and simpler to perform — but also much more robust and protective of the patient. Learn more about the cookies we use and how to change your settings. 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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BS EN ISO 10993-2:2006
Continue shopping Proceed to checkout. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. Find Similar Items This product falls into the 1993-2 categories. The concept may also be applied more generally to unidentified contaminants. Update to Part 17 to include Thresholds of Toxicological Concern. New content on postmarket monitoring and electronic records. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription.
Search all products by. It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in. Work on an vitro 109933-2 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 1099-32 of the current Guinea Pig maximisation assay.
Nanomaterials, EO residues, hemolysis and more. TC Wrap Up Dec 13, ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation. Username or password invalid.
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. 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.
December Biological evaluation of medical devices Framework for identification and quantification of potential degradation lso. Du abonnerer allerede dette emne. 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. The printed version is available at half price when you buy the electronic version.
The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. Part 18 was substantially revised and is now proposed to ios converted from a Technical Specification to a full standard. Need assistance in biological evaluation of your medical device?
Accept and continue Learn more about the cookies we use and how to change your settings. You may experience issues viewing this site in Internet Explorer 9, 10 or 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.
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Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, Laboratory animals, Testing conditions. Are you sure you want to unsubscribe monitoring?
On Extraction — the 1093-2 Dec 20, 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.
Please choose number of devices you want to open the document on. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. The outcome was addition of MEM elution test to the Annex of the revision draft. Biological evaluation of medical devices – Part 2: Activation 109932- monitoring failed – please try again later or contact iwo.
A major revision of Part 17 on allowable limits for leachables is in the works.