The next revision of ISO 10993-1 is just around the corner!
ISO 10993-1 has been approved to be published in about 7 weeks. The status changed on 18 July 2025.This revision introduces key changes on how it defines and addresses the underlying scientific and risk management principles of biological evaluation. Although the scope and alignment with the ISO 14971 process remain unchanged, testing requirements are extended and significant updates have been introduced.
ISO 10993-1 has been approved for Final Draft International Standard (FDIS) status, and moved to “under publication” status.
The imminent publication is expected to introduce a new mindset (and some complications) for medical device manufacturers, as it introduces key changes for biological evaluation of medical devices primarily on risk management, characterisation of materials and real-world use.
Key changes
- A new risk-based approach in which risk estimation is now mandatory and biological evaluation is part of the device’s overarching risk management. Reasonably foreseeable misuse must be assessed. The revised standard underscores the importance of clinically relevant systemic toxicological risks, which practically involves the alignment of toxicology studies (acute, subacute, sub chronic, and chronic toxicity) with real clinical use durations, not arbitrary classifications.
- Characterisation of materials: the level of scrutiny is higher with increased requirements for data especially for novel or more complex materials. Focus is on nanomaterial risk assessments.
- The revised standard includes Carcinogenic, Mutagenic and Reproductively toxic substances (CMR) and Endocrine Disruptors (ED) in the scope of biocompatibility evaluation, which aligns MDR requirements and serves harmonisation purposes.
- The usage duration is now measured in days, which may result in the up-classification of medical devices to prolonged and/or long-term use. Previously, accumulated exposure was calculated by multiplying the time per use by the number of uses. Now, exposure duration is based on total clinical use time.
- The long-term contact may be applicable based on the presence of bioaccumulated materials i.e. metal ions, DEHP, BPA, PFAS, silicone droplets, silver complexes.
- Contact duration categories were redefined and have been reduced to 4, which may also result in recategorisation challenges.
- Biological endpoints have been updated, which translates into the potential need to assess new effects.
- There is increased emphasis on end-of-life considerations for both new and reprocessed devices.
Also Remember
Animal testing to be replaced by new technologies. The 3R principle (Reduce, Refine, Replace) is now an explicit requirement, which means chemical characterisation and innovative in-vitro methods are upgraded in an effort to minimise or completely replace animal testing.
Of note that AAMI and the FDA voted “no’” advocating that the new version of the standard introduces too many changes to be published so quickly, raising concerns over some new concepts such as the “cumulative use” (how repeated or long-term uses of a device add up in exposure) and the revised categorisation of device contact duration.
How can Evnia help
Evnia’s in-house biocompatibility experts can support you throughout your biological evaluation journey.
We offer expert guidance in:
- Gap assessment of your biological evaluation data
- Strategic testing approaches according to the updated ISO 10993-1 requirements
- An holistic support that aligns biocompatibility and clinical evaluation requirements with global regulatory support
Contact us for an introductory discussion!
