ISO/DIS 10993-1, A New Revision Underway – Analysis of the ISO 10993-1 Standard Revision Draft

The draft of the new revision of ISO 10993-1, addressing the biological evaluation of medical devices (MD), was released at the end of June 2024. Even prior its publication, it is possible to identify key changes allowing for early preparation to meet the new requirements.

General Principles and Risk Management

The new draft of ISO 10993-1 emphasizes the integration of biological evaluation into an overall risk management process, carefully identifying and assessing the risks associated with the MD and its use before starting the testing phase in the biological evaluation process.

The standard has been reorganized, expanding from 7 to 10 sections. Recommendations for conducting a biological evaluation within a risk management process, previously described in informative Annex B in the 2018 version of the standard, are now integrated into the body of the document. The vocabulary concerning risk management is more prominent, emphasizing the need to better integrate biological risk assessment with product-related risk analysis according to ISO 14971.This includes considering risks related to “reasonably foreseeable misuse”. Thus, in addition to the normal and expected use of the device, both intentional or unintentional misuse must be considered in the biological risk assessment.

Classification of Medical Devices

The categorization of MDs has also evolved with clarifications regarding the calculation of exposure duration for MDs in daily contact with tissues and those in intermittent contact (more than 24 hours separate two uses). Table A.1 from the previous version of the standard has been divided into 4 tables based on the type of contact of the MD:

• Contact with intact skin,
• Contact with intact mucous membranes,
• Contact with damaged or broken surfaces or internal tissues other than circulating blood,
• Contact with circulating blood.
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The term “externally communicating devices” has been removed, as these devices are now categorized based on their type of contact. Similarly, the term “effects after implantation” has been replaced by “local effects after contact with tissues.” While the biological parameters, now called “biological effects”, remain unchanged, the risks of genotoxicity and carcinogenicity must now be assessed for more device categories. Annex B of the draft revision justifies these changes

Life Cycle

The previous version of the standard briefly mentioned in section 4.7 that the biological safety of a MD should be assessed throughout its entire lifecycle. The draft revision places greater emphasis on this, with the term “lifecycle” appearing throughout the document. It is specified that all variations in the device’s characteristics during its lifecycle must be taken into account in the biological evaluation. To meet this requirement, manufacturers must thoroughly justify and consider the representativeness of tested samples, the evaluation of risks at product expiration, as well as the modification of the product’s physical characteristics during use, among other factors.

Documentation of the Biological Evaluation Plan

The draft revision of the standard clearly stipulates that the biological evaluation plan must be documented. Unlike the previous version of ISO 10993-1, which was vague on the subject and only mentioned the biological evaluation plan in an informative annex, the new version specifies the elements to be included. It emphasizes the need to document the acceptability criteria for biological risks associated with the MD, covering both the tests conducted and the maximum severity and probability scores, in accordance with ISO 14971.

Qualification of Professionals

Finally, the draft of ISO 10993-1 reinforces the requirement that the biological evaluation must be conducted and reported by competent and experienced professionals, whose education, skills, and experience enable them to make informed decisions based on scientific data and a thorough understanding of the MD concerned. The qualifications of the author and key contributors must be documented, a requirement that was not specified in the previous version of the standard.

Conclusion

In summary, the revision of ISO 10993-1 strengthens the integration of risk management and documentation requirements, while clarifying device categories and the qualifications of involved professionals. These changes aim to improve the safety of MDs throughout their lifecycle. It is important to note that the draft standard does not aim to impose new tests for already marketed MDs with an established and stable safety profile. However, existing data must be re-evaluated to determine the impact of this revision on the biological evaluation of the device.

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