We at Advena UK have invested time assessing the updates to the ISO 10993-1 standard following the ISO 10993-1 update on 18 November 2025. This article has been written to clearly lay out some of the changes and enable individuals to know how and when to act on this update.
ISO 10993-1 is the backbone to all biological safety evaluations that are conducted on medical devices, meaning that this update impacts all manufacturers of medical devices in one way or another.
There is no hiding that the changes are significant, but in a positive way.
The standard has made strides in more universal understanding of terms and implementation requirements while aligning itself to existing standards from the 10993 and other standard series – making it easier for manufacturers to know what they need to do to demonstrate biological safety of their medical devices.
Simply put, the standard is simple and progressive.
What’s been removed, what’s new and what is here to stay?
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Table A.1
Arguably, the backbone to biological evaluations that have been conducted to date will no longer look familiar. This critical table has been moved from the Annexes to the main text of the standard to be a set of 4 embedded tables to prevent essential guidance being passed over.
The new look tables have been devised according to contact type, are smaller and more practical for manufacturers and evaluators to use.
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Externally communicating Devices
Always wondered what was meant by this? You no longer need to wonder! The term externally communicating has been removed from the standard due to the ambiguity resulting in biological evaluations that do not assess the device appropriate to its intended use.
Any device previously categorised as externally communicating will have to be assessed according to the new tables.
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- Biological Safety End Points
The endpoints of ISO 10993-1 are here to stay as a pillar of biological safety evaluation, however…
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- Endpoints will now go by the new term of ‘biological effects’
Genotoxicity, material mediated pyrogenicity and systemic toxicity have greater scope to enable the assessor to define what is needed and the requirement to look at the state-of-the-art status of the device.
This is good news for how to define biological effects for a device with a more pragmatic approach, and the implementation of the 2025 update maintains that justification for testing not conducted is acceptable as per current practices but makes the requirement for the justification clear and explicit.
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- Post-Market Surveillance Data
A game changing moment for most manufacturers, particularly that of legacy devices who may have limited biological safety data is here.
The new standard edition makes it clear that when evaluating reasonably foreseeable misuse such as use outside a devices’ intended use, looking at device lifecycle or simply looking to fill a gap in data, post-market surveillance and clinical literature can be used where appropriate.
The feedback loop is now explicit, showing alignment to ISO 14971 and expectations of regulatory compliance.
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- Terminology Updates
It is no secret that the industry has struggled to comprehend some of the language in the 10993-standard series.
Many parts have been updated over the years, but Part 1 has now been more greatly aligned to ISO 14971. This means that when looking at a risk management process for biological safety, you can utilise existing principles from your risk management file process. A risk-based approach is emphasised, and terminology corresponds while reasonably foreseeable is made not only clearer but an explicit requirement.
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- ‘Other Biological Effects’
The addition of this section means that more consideration of effects based on clinical use can be made. It also means that brief and low contact devices, such as lancets have a better framework for evaluation.
- ‘Contact duration’
One of the most debated things in biological safety evaluations is contact duration. A lot of knowledge and experience has been gained since the previous iteration of the standard and the changes in this update evidence the culmination of this from the committee responsible for its update.
Contact duration will no longer see you calculating hours and minutes of contact. Any portion of a day is a day. Simple and means that you count calendar days when looking at cumulative contact time and nothing more. Not only does this mean standardised approaches understood by manufacturers and reviewers alike but, there is provision for intermittent contact is made and ‘unless otherwise justified’ is included to allow pragmatism based on intended use of the device.
While the change is simplistic and clear, manufacturers should be aware that it could lead to re-categorisation.
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- ‘Implantation effect’
It is common for assessors of biological safety to state that anything related to implantation is ‘not applicable’, this has been the practice for years. With the update comes the update related to implantation effects. The term has been changed to consider local effects after tissue contact. This means that devices that come into contact with a surgical site even if they are not an implant must be assessed for any biological response.
How to implement changes to Biological Evaluation Plans and Reports according to ISO 10993-1:2025
Firstly, there is no need to panic, while there is no official verdict, a 2-year transition timeline has been proposed by the relevant committees.
Secondly, while there are significant changes and potentially a lot of impact, it does not need to be considered detrimental.
Thirdly, we’ve created the following schematic to help you decipher where you need to start and what to do next based on the type of device you have and the status of your current biological evaluation.
Implementation should flow far easier than previous iterations of the standard; there are clear sections on the criteria of the biological evaluation plan and the report with the risk concepts in between following manufacturers existing risk management processes.
Core Insights/Key Takeaways
- Obtain and read the standard, get a feel for it and internally discuss the impact with relevant personnel
- The update is more ‘user friendly’, terms are more familiar and encourage interaction with existing risk management processes
- If you need to, speak with your Notified Body and their expectations for implementation
- Document a gap analysis for legacy devices
- Plan, Plan, Plan
- Plan how to fill any gaps identified for legacy devices
- Plan how to implement the full standard to the biological evaluation plan and report for all devices
- Ensure that the plan covers the review of all device categorisation being evaluated against the new criteria with particular attention to those previously defined as externally communicating and all devices reviewed for contact duration calculations.
- Plan how to integrate ISO 10993-1 into your risk management system processes
- Implement following the clear criteria of the standard; internal processes should be updated in alignment with the new requirements.
- Create, Update & Maintain biological evaluation plans, reports and associated risk management files in accordance with ISO 10993-1 and ISO 14971 requirements and internal processes.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advenamedical.com) or phone (01926 800153) to start a conversation today.
