Medical Device Biocompatibility

 

 

Medical devices require varying degrees of biocompatibility testing according to their classification. The main source of guidance on the essential requirements for biological safety is ISO 10993:2003 Biological evaluation of medical devices. This standard defines the device in terms its invasiveness and duration of patient contact.

MET has produced a Medical Device Biocompatibility Test Requirements Chart   (PDF printer version)

Whatever your product MET can give accurate advice on the minimum testing requirements for both CE marking and FDA submissions. All our testing is carried out under rigorous laboratory control. You can have complete confidence in having the correct portfolio of tests in your technical file and universal acceptance of the results.

Biological safety testing for medical devices includes chemical / materials characterisation of materials. Comprehensive testing for both FDA submissions and CE Technical Files  Is available from MET.

Contact us today for a rapid assessment for your product.

Components of ISO 10993 which are relevant to medical device manufacturers

ISO 10993-1:2003 Biological evaluation of medical devices --
Part 1: Evaluation and testing.

ISO 10993-3:2003 Biological evaluation of medical devices --
Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

ISO 10993-4:2002 Biological evaluation of medical devices --
Part 4: Selection of tests for interactions with blood.

ISO 10993-5:1999 Biological evaluation of medical devices --
Part 5: Tests for in vitro cytotoxicity.

ISO 10993-6:2007 Biological evaluation of medical devices --
Part 6: Tests for local effects after implantation.

ISO 10993-7:2008 Biological evaluation of medical devices --
Part 7: Ethylene oxide sterilization residuals.

ISO 10993-9:1999 Biological evaluation of medical devices --
Part 9: Framework for identification and quantification of potential degradation products.

ISO 10993-10:2002 Biological evaluation of medical devices --
Part 10: Tests for irritation and delayed-type hypersensitivity.

ISO 10993-11:2006 Biological evaluation of medical devices --
Part 11: Tests for systemic toxicity

ISO 10993-13:1998 Biological evaluation of medical devices --
Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO 10993-14:2001 Biological evaluation of medical devices --
Part 14: Identification and quantification of degradation products from ceramics

ISO 10993-15:2000 Biological evaluation of medical devices --
Part 15: Identification and quantification of degradation products from metals and alloys

ISO 10993-16:1997 Biological evaluation of medical devices --
Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-17:2002 Biological evaluation of medical devices --
Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18:2005 Biological evaluation of medical devices --
Part 18: Chemical characterization of materials

ISO/TS 10993-19:2006 Biological evaluation of medical devices --
Part 19: Physico-chemical, morphological and topographical characterization of materials

ISO/TS 10993-20:2006 Biological evaluation of medical devices --
Part 20: Principles and methods for immunotoxicology testing of medical devices