ISO 10993 Biological Evaluation of Medical Devices

ISO-10993(Biological Evaluation of Medical Devices), a standard for evaluating the biocompatibility of a medical device or its components. Depending on the nature type and duration of body contact of a medical device, tests for some or all of the following effects may be recommended:

  • (ISO 10993-1) - Risk management process
  • (ISO 10993-2) - Animal welfare requirements
  • (ISO 10993-3) - Tests for genotoxicity,carcinogenicity and reproductive toxicity
  • (ISO 10993-4) - Test for medical devices that interact with blood,Hemocompatibility
  • (ISO 10993-5) - Test for in vitro Cytotoxicity
  • (ISO 10993-6) - Tests for evaluating the local effects of implant material on living tissue
  • (ISO 10993-7) - Ethylene oxide sterilization residuals
  • (ISO 10993-8) - For biological tests selection and qualification of reference materials
  • (ISO 10993-9) - Framework for identification and quantification of potential degradation products
  • (ISO 10993-10) - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
  • (ISO 10993-11) - Tests for acute systemic toxicity,Sub acute/sub chronic
  • (ISO 10993-12) - For Sample preparation and reference materials
  • (IS0 10993-13) - Test for Identifying and quantifying degraded products fiom polymeric medical devices
  • (ISO 10993-14) - Identifying and quantifying degraded products from ceramics
  • (ISO 10993-15) - Identifying and quantifying degraded products from metals and alloys
  • (ISO 10993-16) - Design of Toxicokinetic study for degradation products and leachable
  • (ISO 10993-17) - Specifies the determination of allowable limits for substances leachable from medical devices
  • (ISO 10993-18) - Chemical characterization test for materials
  • (IS0 10993-19) - This test is for evaluating Physico-chemical,topographical and morphological characterization ofmaterials
  • (ISO 10993-20) - Immunotoxicology testing of medical devices