ISO 10993

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices.[1] For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".

ISO 10993-1:2009 & FDA endpoints for consideration

The following table provides a framework for the development of a biocompatibility evaluation. Different biological endpoints may require evaluation for particular medical devices, including either additional or fewer endpoints than indicated. If it is unclear in which category a device falls, consulting device-specific guidances or contacting the appropriate US Food and Drug Administration (FDA) review division for more information is possible. The table "Endpoints to be addressed in a biological risk assessment" was revised by the 2018 edition of ISO 10993-1. The selection of endpoints for the biocompatibility evaluation is determined by the nature of body contact (e.g. implant device) and contact duration (e.g. long term contact of more than 30 days).

Medical device categorization by Biological Effect
Nature of Body Contact Contact Duration

A-limited

(≤24 h)

B-prolonged

(>24 h to 30 d)

C-permanent

(> 30 d)

 Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Material-Mediated Pyrogenicity Subacute/Subchronic Toxicity Genotoxicity Implantation Hemocompatibility Chronic Toxicity Carcinogenicity Reproductive/Developmental Toxicity Degradation
Category Contact
Surface device Intact skin A X X X
B X X X
C X X X
Mucosal membrane A X X X
B X X X O O O O
C X X X O O X X O O
Breached or compromised surface A X X X O O
B X X X O O O O
C X X X O O X X O O O
External communicating device Blood path, indirect A X X X X O X
B X X X X O O X
C X X O X O X X O X O O
Tissue/bone/dentin A X X X O O
B X X X X O X X X
C X X X X O X X X O O
Circulating blood A X X X X O O X
B X X X X O X X X X
C X X X X O X X X X O O
Implant device Tissue/bone A X X X O O
B X X X X O X X X
C X X X X O X X X O O
Blood A X X X X O O X X
B X X X X O X X X X
C X X X X O X X X X O O
X = ISO 10993-1:2009 recommended endpoints for consideration
O = Additional FDA recommended endpoints for consideration

List of the standards in the 10993 series

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-6:2016 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 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials (withdrawn)
  • ISO 10993-9:2019 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12:2021 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14:2009 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15:2009 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16:2018 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 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
  • ISO/TS 10993-19:2020 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
  • ISO/TR 10993-22:2017 Biological evaluation of medical devices Part 22: Guidance on nanomaterials
  • ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
  • ISO/TR 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

See also

References

  1. ↑ "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)" (PDF). fda.gov. FDA. Retrieved 23 January 2017.
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