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.

Author: Nizahn Shakamuro
Country: Cayman Islands
Language: English (Spanish)
Genre: Education
Published (Last): 2 July 2012
Pages: 365
PDF File Size: 14.92 Mb
ePub File Size: 17.93 Mb
ISBN: 865-8-38835-638-1
Downloads: 65625
Price: Free* [*Free Regsitration Required]
Uploader: Kigall

The printed version is available at half price when you buy the electronic version. You may experience issues viewing this site in Internet Explorer 9, 10 or The concept may also be applied more generally to unidentified contaminants. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

Update to Part 17 to include Thresholds iao Toxicological Concern. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard.

A major revision of Part 17 on allowable limits for leachables is in the works. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

BS EN ISO 10993-2:2006

December Biological evaluation of medical devices 110993-2 for identification and quantification of potential degradation products. Are you sure you want to unsubscribe? 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.

Activation of monitoring failed – please try again later or contact us. Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model. An annex on risk management. Do not show this again. Learn more about the cookies we use and how to change your settings.


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.

On Extraction — the vagaries Dec 20, The outcome was addition of MEM elution test to the Annex of the revision draft. Take the smart route to manage medical device compliance. We use cookies to make our website easier to use and to better understand iao needs.

ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements

Click to learn more. 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.

Accept and continue Learn more about the cookies we use and how to change your settings. ISO on blood compatibility is under revision with focus 1099-2 a new haemolysis method currently under round robin evaluation.

The kso approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you are logged in.

Username or password invalid. 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.

Worldwide Standards We can source any standard from anywhere in the world. We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.


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. Exigences relatives a la protection 1093-2 animaux Title in German Biologische Beurteilung von Medizinprodukten. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

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. Animals, Animal welfare, Planning, Personnel, Laboratory techniques, Test specimens, Laboratory workers, Laboratory testing, Medical equipment, Surgery, Biological analysis and testing, 10939-2 animals, Testing conditions.

Nanomaterials, EO residues, hemolysis isi more.

Please download Chrome or Firefox or view our browser tips. You may find similar items within these categories by selecting from the isp below:. The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers.

Kontakt venligst Dansk Standard. Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. Continue shopping Isl to checkout. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made 10939-2 the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.

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. Are you sure you want to unsubscribe monitoring?