ISO 10993-1:2025 Revision Published
New revision of important biocompatibility standard published – I.S EN ISO 10993-1:2025
I.S EN ISO 10993-1:2025 – Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process was published at the end of 2025. This is a key standard for the medical device sector to develop biocompatibility testing plans and technical document to demonstrate the biological safety of products. The new standard specifies general requirement and principles governing biological evaluation of biological evaluation of medical devices within a risk management process aligned to ISO 14917.
The new standard is now available from the NSAI Published standard catalogue – see link below:
I.S. EN ISO 10993-1:2025 Biological evaluation of medical devices
Key Changes
- Addition of General principles
General principles are included that incorporate the medical device life cycle and looks at biological evaluation within a risk management framework. Animal welfare is also incorporated in the general principles.
- Development and documentation of biological evaluation plan
A documented plan for the finished medical device or family of devices under evaluation covering a number of technical topics such as intended use, reasonably foreseeable misuse, medical device categorization, identification of biological hazards, criteria for acceptability of specific biological risks etc.
- Changes to presentation of systemic toxicity
The new revision includes a general category of systemic toxicity and evaluation should reflect the duration of use. The use of acute, subacute, sub-chronic and chronic has been removed
- Changes to device contact categories to 4 groups in contact with:
- Intact skin
- Intact mucosal membranes
- Breached or compromised surfaces or internal tissues other that blood
- Blood
- Changes in requirements for genotoxicity and carcinogenicity evaluation
Genotoxicity evaluation of prolonged contact of medical devices has been added and this is now applicable for all medical devices with prolonged contact except for devices only in contact with skin.
Carcinogenicity evaluation is applicable for all long-term medical devices where chronic toxicity is evaluated.
For more detailed information the full standard should be reviewed for all changes.
What to do next?
Medical device manufacturers should review the new revision of I.S. EN ISO 10993-1:2025 and carry out a gap analysis to identify new biocompatibility data that may be required for each medical device or family of medical devices. The changes in contact categories in the new standard may require additional testing and technical information to be collated.
Plans should be developed to identify and collate any additional information that may be needed to demonstrate compliance. Any plans for upgrading to the new revision should be discussed with Conformity assessment organization to ensure they are aware of planned changes and when to compliance is expected.
Development of supporting international guidance documents
The international technical committee that developed the new revision, ISO/TC 194, has a number of new guidance documents proposed to assist with implementation of the new revision. There are six new guidance documents being developed:
- Project 1: Biological evaluation of medical devices – Guidance on risk estimation in the application of ISO 10993-1
- Project 2: Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1
- Project 3: Biological evaluation of medical devices – Guidance on the application of ISO 10993-1 throughout the medical device life cycle
- Project 4: Biological evaluation of medical devices – Information on biological equivalence in the application of ISO 10993-1
- Project 5: Biological evaluation of medical devices – Information on reasonably foreseeable misuse in the application of ISO 10993-1
- Project 6: Biological evaluation of medical devices – Information on the use of clinical data in the application of ISO 10993-1
The national committee that monitors medical device standard development is NSAI/TC 5 – Healthcare Standards Consultative Committee. For more information see Healthcare Standards | NSAI, where you can also apply to get involved.
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