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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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. The concept may also be applied more generally to unidentified contaminants.

ISO – Wikipedia

Animal welfare requirements Status: The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. An annex on risk management. Kontakt venligst Dansk Standard. Please download Chrome or Firefox or view our browser tips. Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization.

Medical Devices

You may experience issues viewing this site in Internet Explorer 9, 10 or TC Wrap Up Dec 13, Biological evaluation of medical devices – Part 2: You must be logged in to sign up for monitoring 110993-2 must be logged in to sign up for subscription. A major revision of Part 17 on allowable limits for leachables is in the works.


In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made. Arthur 1093-2 has been involved as an Australian expert member of TC since and was present in Mishima. 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.

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. Take the smart route to manage medical device compliance.

Need assistance in biological evaluation of your medical device? You may find similar items within these categories by selecting from the choices ieo. Learn more about the cookies we use and how to change your settings. 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.

Medical Devices | VUOS a.s.

We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later.


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? Are you sure you want to unsubscribe monitoring? ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation.

Click to learn more. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity 1093-2 to replace the current canine model.

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May 9, admin. Part 18 was substantially revised and is now proposed to be converted from a Ios Specification to a full standard. Continue shopping Proceed to checkout.

Worldwide Standards We can source any standard from anywhere in the world. 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. This website is best viewed with 01993-2 version of up to Microsoft Internet Explorer 8 or Firefox 3.

Nanomaterials, EO residues, hemolysis and more.