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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Institute for Standardization of Serbia Stevana Brakusa 2.
Our certified team has great experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures. Toxicokinetic study design for degradation products and leachables ISO The revised standard includes the isoo of risk assessments and chemical characterization in addition to traditional genetic toxicity tests.
Sample preparation and reference materials ISO Customized Test Designs The increasing number of newly synthesized molecules demands the use of assays providing rapid results and requiring only small amounts of test material. Our tests comply with the current international guidelines e.
Biological evaluation of medical devices – Part 7: Tests for irritation and delayed-type hypersensitivity ISO Selection of tests for interactions with blood ISO Biological evaluation of medical devices – Part 3: This standard is identical to: The biocompatibility risk assessment of medical devices is guided by the ISO series of standards.
Tests for in vitro cytotoxicity ISO Ethylene oxide sterilization residuals ISO Tests for irritation and skin sensitization ISO Framework for identification and quantification of potential degradation products ISO To respond to these market requirements, Eurofins Medical Device Ios offers miniaturized screening tests, allowing us to screen a large number of substances.
10993-3 a link below to download one of our Genetic Toxicology Testing resources. Tests for local effects after implantation ISO Selection of tests for interactions with blood – Amendment 1 ISO Medical devices have the potential to leach substances which, depending on the contact category of the device, can directly contact the human body.
Hence, appropriate evaluation for genetic toxicity as part of the biocompatibility risk assessment is critical. Biological evaluation of medical devices – Part 5: Tests for irritation and delayed-type hypersensitivity – Amendment 1 ISO About Us Info center Standardization.
10993-3 Biological evaluation of medical devices – Part 4: Join Our Mailing List. 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.
Choose Eurofins Medical Device Testing to help you: Establishment of allowable limits for leachable substances ISO Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Biological evaluation of medical devices – Lso 6: Biological evaluation of medical devices – Part 9: Identification and quantification of degradation products from ceramics ISO Tests for systemic toxicity 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.