Free e-book · ISO 10993-1:2025
A practical guide to what changed in the biological evaluation of medical devices, and which actions your team should prioritize now.
8-page executive guide · PDF · Written by Sobel’s Human Safety team
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What changes
ISO 10993-1:2025 is the sixth edition of the standard for the biological evaluation of medical devices. It makes biological evaluation a required part of the ISO 14971 risk management process, introduces new body-contact categories and a clearer way to count contact days, replaces the single Table A.1 with four tables of biological effects, and strengthens the role of chemical characterization, bioaccumulation and alternatives to animal testing under the 3Rs and NAMs (New Approach Methodologies).
In Brazil, the 2025 edition is now published as ABNT NBR ISO 10993-1. Read what it means for ANVISA submissions.
What’s inside
More integrated, more risk-based and more lifecycle-oriented: what that means in practice.
Biological evaluation becomes a required part of risk management, including reasonably foreseeable misuse.
The new body-contact categories and total exposure time for devices with multiple contacts.
The new Annex A and the four tables of biological effects, by type of body contact.
What devices already on the market need to review, from development to end of life.
From mapping scope and categories to a continuous review routine.
A look inside
Eight themes, each with what changed and the action expected from you. Here are two of them.
Get all 8 in the guideWho it is for
Quick check
If you answer “no” or “not sure” to any of them, a 20-minute conversation with our specialists can save weeks later.
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Clear regulatory direction
The right pathway and priorities for your product.
Fast and responsive support
We act quickly to keep projects moving.
Practical guidance
Actionable advice for your next step.
Who wrote it
Sobel’s Human Safety specialists bring more than 20 years of experience in regulatory affairs and biological safety, working on submissions for ANVISA, FDA and EU notified bodies.
Sobel Human Safety team · ISO 9001 certified in Brazil
How Sobel helps
Understand the 8 changes, see the action expected for each one and self-check your file in five steps.
From here, Sobel can help you
Your current file checked against the new ISO 10993-1 structure.
Plan and report developed or updated with ISO 14971 and the 3Rs.
The new standard, NAMs and risk-based approaches for your teams.
Not sure where to start? A gap analysis is the usual first step.
Talk to a specialistFAQ
What manufacturers usually ask before downloading, and what the guide does and does not replace.
Ask your question →Yes. You only share your name, business email and company so we can send you the PDF.
Biological evaluation becomes a required part of ISO 14971 risk management, body-contact and duration categories change, reasonably foreseeable misuse enters the scope, and the single Table A.1 becomes four tables of biological effects. The guide covers all eight changes with the action expected for each.
ISO 10993-1:2025, the sixth edition of the standard, was published in November 2025. In Brazil, ABNT published the new ABNT NBR ISO 10993-1 in September 2026, aligned with the 2025 edition, replacing the 2022 Brazilian edition that was based on the 2018 text.
Start with a documentation gap analysis: map your devices against the new contact categories, check that the Biological Evaluation Plan (BEP) and Report (BER) sit inside the ISO 14971 risk file, and justify every test you ran or did not run. The guide brings a five-step plan and a self-check.
Not automatically. A full documentation review decides whether new data are needed or whether the BEP and BER only need to be revised. A gap analysis answers this for your specific device.
The international standard and what it means in Brazil (ANVISA and the new ABNT NBR ISO 10993-1), the European Union (MDR and IVDR) and the United States (FDA).
Yes. Version 1.3 already covers the Brazilian ABNT NBR edition published in September 2026, and the guide is available in English and in Brazilian Portuguese.
The guide comes with occasional regulatory updates from Sobel, as stated in the consent box. Every email has a one-click unsubscribe link.
Be ready for the update
Compliance with the new edition is essential to keep medical devices on the market in Brazil, Europe and the United States.
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