ISO 10993




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]




Contents






  • 1 ISO 10993-1:2009 & FDA endpoints for consideration


  • 2 List of the standards in the 10993 series


  • 3 See also


  • 4 References





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 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


*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



  • List of ISO standards

  • https://www.iso.org/ics/11.100.20/x/



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..mw-parser-output cite.citation{font-style:inherit}.mw-parser-output q{quotes:"""""""'""'"}.mw-parser-output code.cs1-code{color:inherit;background:inherit;border:inherit;padding:inherit}.mw-parser-output .cs1-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/6/65/Lock-green.svg/9px-Lock-green.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-lock-limited a,.mw-parser-output .cs1-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Lock-gray-alt-2.svg/9px-Lock-gray-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/a/aa/Lock-red-alt-2.svg/9px-Lock-red-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration{color:#555}.mw-parser-output .cs1-subscription span,.mw-parser-output .cs1-registration span{border-bottom:1px dotted;cursor:help}.mw-parser-output .cs1-hidden-error{display:none;font-size:100%}.mw-parser-output .cs1-visible-error{font-size:100%}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration,.mw-parser-output .cs1-format{font-size:95%}.mw-parser-output .cs1-kern-left,.mw-parser-output .cs1-kern-wl-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right,.mw-parser-output .cs1-kern-wl-right{padding-right:0.2em}









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