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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Our tests comply with the current international guidelines e.

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Establishment of allowable limits for leachable substances ISO Sample preparation and reference materials ISO Identification and quantification of degradation products from metals and alloys ISO Selection of tests for interactions with blood – Amendment 1 ISO The recently revised ISO provides guidance on evaluating the genotoxicity, carcinogenicity and reproductive toxicity potential of medical devices. The biocompatibility risk assessment of medical devices is guided by the ISO series of standards.

EVS-EN ISO 10993-3:2009

Chemical characterization of materials ISO Eurofins Medical Device Testing has more than 30 years of experience performing biological safety and activity testing, including a broad range of Genetic Toxicology Ixo. To respond to these market requirements, Eurofins Medical Device Testing offers miniaturized screening tests, allowing us to screen a large number of substances.


Hence, appropriate evaluation for genetic toxicity as part of the biocompatibility risk assessment is critical. Tests for irritation and delayed-type hypersensitivity ISO Biological evaluation of medical devices – Part The revised standard includes the use of risk assessments and chemical characterization in addition to traditional genetic toxicity tests.

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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 ISO Biological evaluation of medical devices – Part 6: Although conformance to ISO is required by various national regulatory agencies for specific medical device categories, there are still differences in the interpretation of the requirements within the standard which may require additional testing.

Tests for in vitro cytotoxicity ISO Yes No Don’t know. Our certified team has great experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures.

Genetic Toxicology – Eurofins Medical Device Testing – Eurofins Scientific

Customized Test Designs The increasing number of newly synthesized molecules demands the use of assays providing rapid results and requiring only small amounts 109993-3 test material. Choose Eurofins Medical Device Testing to help you: Tests for systemic toxicity ISO Biological evaluation of medical devices – Part 5: Related international standards This standard is identical to: About Us Info center Standardization.


Eurofins Medical Device Testing provides the scientific resources and expertise you need, with the most reliable and timely results possible. Identification and quantification of degradation products from ceramics ISO Tests for irritation 10993-33 delayed-type hypersensitivity – Amendment 1 ISO Our laboratory team has extensive experience, not only in serving the testing needs of diverse clients, but also in conducting in vitro assay validation studies.

Biological evaluation iwo medical devices – Part 9: Framework for identification and quantification of potential degradation products ISO Tests for local effects after implantation ISO Evaluation and testing ISO Biological evaluation of medical devices – Part 4: Join Our Mailing List.

Last modified: April 10, 2020