ISO 10993

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The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices. 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]

ISO 10993-1:2009 & FDA endpoints for consideration[edit]

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 FDA review division for more information is possible.

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[edit]

*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 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • 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 10993-16:2017 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 & ISO/CD 10993-18 [Under development] 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
  • ISO/TR 15499:2012 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

See also[edit]

References[edit]

  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.