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]
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
References
- ↑ "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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