ISO 10993-1 Biological Evaluation — Laboratories & Overview
ISO 10993-1 frames risk-based biological evaluation, not a fixed test list. FDA partially recognizes the 2025 edition with exceptions and accepts 2018-edition declarations for premarket submissions until July 1, 2029. The transition does not automatically require all legacy devices to be retested. FDA's September 2023 risk-based guidance remains final.
When is it used?
- Writing or revising a biological evaluation plan
- Deciding which biological endpoints need data for a given device
- Assessing the effect of a material, process or sterilisation change
- Bringing a legacy device evaluation up to the current family of standards
Sample considerations
- Contact type and duration are central inputs — define them before selecting tests.
- Existing material and chemical data can address endpoints without new biological testing in some cases.
- Evaluation applies to the final, finished, sterilised device, not to raw material alone.