ISO 10993

The ISO 10993 is an ISO standard series for the biological evaluation of medical devices. The standard is especially relevant to medical device manufacturers and testing laboratories. Objective of the standard is to evaluate the biological assessment as regards the compatibility of the materials used with the body. There are not only products, but also starting materials for the manufacture of medical devices studied. The standard series does not restrict itself only to implantable medical devices, but affects a large number of medical devices. In addition to biological testing, the standard includes additional physico- chemical tests and analyzes of solutes and substances and prescribes the observance of limits on leachable substances.

ISO 10993 is published in Germany as DIN standard DIN EN ISO 10993.

The ISO 10993 consists of several parts:

  • ISO 10993-1 evaluation and testing within a risk management process
  • ISO 10993-2 animal welfare rules
  • ISO 10993-3 Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 Selection of tests for interactions with blood
  • ISO 10993-5 tests for in vitro cytotoxicity
  • ISO 10993-6 Tests for local effects after implantation
  • ISO 10993-7 ethylene oxide sterilization residues
  • ISO 10993-8 Selection and suitability of reference materials for biological tests
  • ISO 10993-9 Framework for identification and quantification of potential degradation products
  • ISO 10993-10 Tests for irritation and skin sensitization
  • ISO 10993-11 Tests for systemic toxicity
  • ISO 10993-12 Sample preparation and reference materials
  • ISO 10993-13 Identification and quantification of degradation products from polymeric medical devices in
  • ISO 10993-14 Identification and quantification of degradation products ceramic
  • ISO 10993-15 Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 design and Toxicokinetic study design for degradation products and leachables ingredients
  • ISO 10993-17 Establishment of allowable limits for leachable components
  • ISO 10993-18 Chemical characterization of materials
  • ISO 10993-19 Physical / chemical, mechanical and morphological characterization
  • ISO 10993-20 principles and procedures for the immune Toxicological investigation of medical devices
  • ISO
  • Medical
Implant (medicine)
310023
de