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.
|Published (Last):||3 August 2015|
|PDF File Size:||5.24 Mb|
|ePub File Size:||4.95 Mb|
|Price:||Free* [*Free Regsitration Required]|
Toxicokinetic study isk for degradation products and leachables ISO Biological evaluation of medical devices – Part 5: Medical devices have the potential to leach substances which, depending on the contact category of the device, can directly contact the human body.
Biological evaluation of medical devices – Part 6: FAQ What is standard Become a member?
NBN EN ISO | NBN
Identification and quantification of degradation products from metals and alloys ISO Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Framework for identification and quantification of potential iao products ISO Ethylene oxide sterilization residuals ISO The revised standard includes the use of risk assessments and chemical characterization in addition to traditional genetic toxicity tests. The biocompatibility risk assessment of medical devices is guided by the ISO series of standards.
Biological evaluation of medical devices – Part 3: Contact Us Request More Info. Tests for local effects after implantation ISO Tests for systemic toxicity ISO Related international standards This standard is identical to: 1993-3 Us Info center Standardization.
Chemical characterization of materials ISO Evaluation and testing ISO Tests for 10939-3 vitro cytotoxicity ISO Identification and quantification of degradation products from polymeric medical devices ISO Biological evaluation of medical devices – Part Tests for irritation and delayed-type hypersensitivity – Amendment 1 ISO Selection of tests for interactions with blood ISO Biological evaluation of medical devices – Part 7: Biological evaluation of medical devices – Part 1: Selection of tests for interactions with blood – Amendment 1 ISO Biological evaluation of medical devices – Part 4: Sample preparation and reference materials ISO Biological evaluation of medical devices – Part 9: Join Our Mailing List.
Our tests comply with the current international guidelines e.
BS EN ISO series – BSI Shop
Eurofins Medical Device Testing 1099-3 the scientific resources and expertise you need, with the most reliable and timely results possible. 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. Our certified team has great experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures.
Tests for irritation and skin sensitization ISO Do you use standards in your work?
Identification and quantification of degradation products from ceramics ISO Click a link below to download one of our Genetic Toxicology Testing resources. Customized Test Designs The increasing number of newly synthesized molecules demands 110993-3 use of assays providing rapid results and requiring only small amounts of test material.
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. Yes No Don’t know. This standard is identical to: Hence, appropriate evaluation for genetic toxicity as part of the biocompatibility risk assessment is critical.
The ISO standard provides guidance on the selection and preparation of test samples, and the selection of tests to evaluate genetic toxicity.