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 & endpoints for consideration
Part 1 of the Standard provides general information about the biocompatibility evaluation process. The current version was published in 2018, replacing the previous version published in 2009. A new version is expected to be published by the end of 2025.[2]
Table A.1 is used to classify medical devices according to the nature (e.g. implant device) and duration (e.g. long term contact of more than 30 days) of their interaction with the human body. This is a core aspect of the evaluation process that will determine which endpoints should be evaluated. However, the relevant endpoints should be decided as part of a risk-evaluation process that goes beyond the cageroziation of the medical device. Even if an endpoint is excluded by the categorization, it may be necessary if the risk-evaluation recommends it.
The Food and Drug Administration (FDA) published a guidance document to support the evaluation process, clarifying their interpretation of some key aspects of the normative [1].
| 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
With the exception of Part 1, each part focuses on a specific aspect of the biocompatibility evaluation process. The title indicates the publication year of the latest edition. Withdrawn parts are no longer relevant and will not be maintained or updated.
ISO 10993-1: 2018. Evaluation and testing within a risk management process
ISO 10993-2: 2022. Animal welfare requirements
ISO 10993-3: 2014. Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4: 2017. Selection of tests for interactions with blood
ISO 10993-5: 2009. Tests for in vitro cytotoxicity.
ISO 10993-6: 2016. Tests for local effects after implantation
ISO 10993-7: 2008. Ethylene oxide sterilization residuals
ISO 10993-8: 2000. Selection of reference materials (withdrawn)
ISO 10993-9: 2019. Framework for identification and quantification of potential degradation products
ISO 10993-10: 2010. Tests for irritation and skin sensitization (withdrawn)
ISO 10993-11: 2017. Tests for systemic toxicity
ISO 10993-12: 2021. Sample preparation and reference materials
ISO 10993-13: 2010. Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14: 2001. Identification and quantification of degradation products from ceramics
ISO 10993-15: 2019. Identification and quantification of degradation products from metals and alloys
ISO 10993-16: 2017. Toxicokinetic study design for degradation products and leachables
ISO 10993-17: 2023. Toxicological risk assessment of medical device constituents
ISO 10993-18: 2020. Chemical characterization of medical device materials within a risk management process
ISO 10993-19: 2020. Physico-chemical, morphological and topographical characterization of materials
ISO 10993-20: 2006. Principles and methods for immunotoxicology testing of medical devices
ISO 10993-22: 2017. Guidance on nanomaterials
ISO 10993-23: 2021. Tests for irritation
ISO 10993-33: 2015. Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
See also
References
- ^ a b "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)". fda.gov. FDA. Retrieved 23 January 2017.
- ^ "ISO 10993-1:2018". ISO. Retrieved 2025-09-02.
Notes
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