ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International Standard (FDIS) was published earlier this spring, and the voting was closed the July 17. The standard was approved and is now under publication.

What’s changing?

The new version of ISO 10993-1 strengthens the alignment between biological evaluation and risk management principles.

Key changes include:

  • Closer integration with the risk management process as defined in ISO 14971. The biological evaluation is now more explicitly linked to the stages of the risk management process.
  • A revised method for calculating total exposure, focusing on the number of days from first to last exposure, rather than total contact time.
  • The table in former Annex A covering biological endpoints is replaced by several smaller tables integrated into the main text. The term biological endpoint is replaced by the term biological effect. The tables list which effects to consider for different types of device contact (intact skin, mucosal membranes, internal tissues, circulating blood). Notably, material-mediated pyrogenicity is no longer listed as a biological effect in any of these tables.
  • New requirements for the Biological Evaluation Plan, which should include or reference criteria for the acceptability of specific biological risks associated with the medical device.
  • A new annex with guidance on characterization

What does this mean for you as a manufacturer?

Manufacturers will be expected to apply the new version whenever a biological evaluation needs to be updated (for example, due to changes in the device design, materials, or manufacturing process).

To prepare, we recommend performing a gap analysis of your current biological evaluations against the new standard. In particular, consider the following:

  • Does the revised method for calculating total exposure change which biological effects you need to evaluate? If so, plan ahead to ensure future compliance.
  • Do your SOPs and templates for biological evaluation need to be updated? If yes, take steps to align them with the new requirements.

How we can support you

At Aurevia (formerly QAdvis), we closely monitor regulatory developments and help our clients stay ahead of changes. We offer:

  • Gap analyses and documentation reviews
  • Support in updating biological evaluations

Want to know more?

Feel free to reach out if you’d like to discuss how the upcoming version of ISO 10993-1 may affect your products and documentation. We’re here to help you stay compliant, informed, and ready.