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.

Author: Tojajora Voll
Country: Tajikistan
Language: English (Spanish)
Genre: Relationship
Published (Last): 10 June 2017
Pages: 28
PDF File Size: 16.75 Mb
ePub File Size: 17.92 Mb
ISBN: 785-3-12711-523-4
Downloads: 49110
Price: Free* [*Free Regsitration Required]
Uploader: Mausar

FAQ What is standard Become a member?

Join Our Mailing List. Our tests comply with the current international guidelines e.

EVS-EN ISO 10993-3:2009

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 design for degradation products and leachables ISO Biological evaluation of medical devices – Part Related international standards 1093-3 standard is identical to: About Us Info center Standardization.

The revised standard includes the use of risk assessments and 1093-3 characterization in addition to traditional genetic toxicity tests.

This standard is identical to: Identification and quantification of degradation products from isoo medical devices ISO Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood ISO Biological evaluation of medical devices – Part 9: 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.

  KATHY REICHS SEGRETI PDF

The recently revised ISO provides guidance on evaluating the genotoxicity, carcinogenicity and reproductive toxicity isp of medical devices. To respond to these market requirements, Eurofins Medical Device Testing offers miniaturized screening tests, allowing us to screen a large number of substances.

Tests for irritation and skin sensitization ISO Privacy Notice Conditions of Use.

Contact Us Request More Info. Tests for irritation 109993-3 delayed-type hypersensitivity – Amendment 1 ISO Tests for in vitro cytotoxicity ISO Tests for genotoxicity, carcinogenicity and reproductive toxicity 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 Studies.

Do you use standards in your work? Identification and quantification of degradation products from ceramics 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. Chemical characterization of materials ISO Eurofins Medical Device Testing provides the scientific resources and expertise you need, with the most reliable and timely results possible.

Genetic Toxicology – Eurofins Medical Device Testing – Eurofins Scientific

Yes No Don’t know. 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 Evaluation and testing ISO Biological evaluation of medical devices – Part 5: The biocompatibility risk assessment of medical devices is guided by the ISO series of standards.

  FWD S42H2 PDF

Sample iiso and reference materials ISO Click a link below to download one of our Genetic Toxicology Testing resources.

NBN EN ISO | NBN

Our certified team has great experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures. Tests for local effects after implantation ISO Establishment of allowable izo for leachable substances ISO Tests 10993–3 irritation and delayed-type hypersensitivity ISO 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 systemic toxicity ISO Biological evaluation of medical devices – Part 3: Biological evaluation of medical devices – Part 1: Institute for Standardization of Serbia Stevana Kso 2. Biological evaluation of medical devices – Part 7: Biological evaluation of medical devices – Part 6: Ethylene oxide sterilization residuals ISO Choose Eurofins Medical Device Testing to help you: