Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
Sets the framework for judging the biological safety of a device inside a risk management process. It helps decide which biological endpoints matter for a device, based on the kind of body contact and how long it lasts. Other parts of the series describe the test methods.
The sixth edition replaced the 2018 fifth edition and changed the title. FDA guidance of 2023 still discusses the 2018 edition.
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Sixth edition 2025-11 | - | Recognition number 2-313. Partial recognition. The FDA publishes a Supplemental Information Sheet on the extent of recognition and its own modified endpoint matrix.. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. The FDA guidance of 2023 on the use of ISO 10993-1 was written for the 2018 edition. Recognition number 2-258 (2018 edition) was replaced. |
| European Union | Harmonized | EN ISO 10993-1:2025 (ISO 10993-1:2025) | - | Recognition number MDR entry 54. Effective June 17, 2026. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Recognized | EN ISO 10993-1:2009 with corrigendum AC:2010 | - | Recognition number List row 69. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not.. The designated reference is the 2009 edition of the first part of the series. |
| Japan | Adopted | ISO 10993-1:2018 (identical JIS version) | JIS T 0993-1:2020医療機器の生物学的評価―第１部：リスクマネジメントプロセスにおける評価及び試験 | The notice on biological safety evaluation says the evaluation should follow ISO 10993-1 or the identical JIS version. |
| China | Adopted | ISO 10993-1:2018, identical adoption | GB/T 16886.1-2022Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Effective May 1, 2023. Recommended national standard. Where no mandatory standard exists, the rules encourage applicants to use recommended standards. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used.. For devices subject to clause 5.3.2 of the fifth edition (2018), the list says more testing than that clause names may be needed. |
| Australia | Referenced | - | - | The guidance refers to the ISO 10993 series as a whole and does not name an edition.. Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. The TGA says manufacturers must meet or exceed the requirements of the series. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB/T 16886.1-2022, GB/T 16886.4-2022, GB/T 16886.5-2017, GB/T 16886.7-2015, GB/T 16886.10-2017, GB/T 16886.11-2021, GB/T 16886.12-2017, GB/T 16886.18-2022, ISO 10993-9, ISO 10993-15, ISO 10993-4, ISO 10993-10. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.