ISO 10993-3 PDF

ISO Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. toxicité sur la reproduction. STANDARD. ISO. Third edition. . Reference number. ISO (E). Provläsningsexemplar / Preview. ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file.

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The recently revised ISO provides guidance on evaluating the genotoxicity, carcinogenicity and reproductive toxicity potential of medical devices.

Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Institute for Standardization of Serbia Stevana Brakusa 2. Biological evaluation of medical devices – Part 5: Chemical characterization ios materials ISO Tests for local effects after implantation ISO Identification and quantification of degradation products from metals and alloys ISO Contact Us Request More Info.

Our certified team has great experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures.

Our tests comply with the current international guidelines e. Ethylene oxide sterilization residuals ISO Choose Eurofins Medical Device Testing to help you: Hence, appropriate evaluation for genetic toxicity as part of the biocompatibility risk assessment 109993-3 critical. Tests for irritation and skin sensitization ISO Tests for irritation and delayed-type hypersensitivity – Amendment 1 ISO Evaluation and testing ISO Join Our Mailing List.

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Genetic Toxicology – Eurofins Medical Device Testing – Eurofins Scientific

Tests for systemic toxicity ISO Click a link below to download one of our Genetic Toxicology Testing resources. The biocompatibility risk assessment of medical devices is guided by the ISO series of standards. Identification and quantification of degradation products from ceramics ISO The ISO standard provides guidance on the selection and preparation of test samples, and the selection of tests to evaluate genetic toxicity.

Selection of tests for interactions with blood – Amendment 1 ISO Biological evaluation of medical devices – Part 7: Yes No Don’t know. Identification and quantification of degradation products from polymeric medical devices ISO FAQ What is standard Become a member?

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Biological evaluation of medical devices – Part This standard is identical to: Biological evaluation of medical devices – Part 3: Do you use standards in your work? About Us Info center Standardization. To respond to these market requirements, Eurofins Medical Device Testing offers miniaturized screening tests, allowing us to screen a large number of substances. Biological evaluation of medical devices – Part 4: Establishment of allowable limits for leachable substances ISO Biological evaluation of medical devices – Part 6: Framework for identification and quantification of potential degradation products ISO Selection of tests for interactions with blood ISO Tests for in vitro cytotoxicity ISO Although conformance to ISO is required by various national regulatory agencies 10939-3 specific medical device categories, there are still differences in the interpretation of the requirements within the standard which may require additional testing.

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Eurofins Medical Device Testing has more than 30 years of experience performing biological safety and activity testing, including a broad range of Genetic Toxicology Studies. Tests for irritation and delayed-type hypersensitivity ISO Sample preparation and reference materials ISO Our laboratory team has 109933- experience, not only in serving the testing needs of diverse clients, but also in conducting in vitro assay validation studies.

Medical devices have the potential to leach substances which, depending on the contact category of the device, can directly contact the human body. Toxicokinetic study 109933 for degradation products and leachables ISO