Meet Sobel at MEDICA 2026·Düsseldorf, 16–19 Nov.Book a meeting with us →Book a meeting 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 Clinical Evidence & Product Safety team
Get the free guide
We send the PDF straight to your inbox.
Trusted by manufacturers in Brazil and abroad
What changes
ISO 10993-1:2025 is the sixth edition of the standard for the biological evaluation of medical devices. It reorganizes biological evaluation around 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.
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 is structured around the ISO 14971 risk management process, including reasonably foreseeable misuse.
The new body-contact categories and total exposure time for devices with multiple contacts.
The role of chemical characterization 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 short conversation with our team can help you plan the next steps.
CLIENT VOICES
“
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
“
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
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 specialists in regulatory affairs and biological safety prepare biological evaluation documentation for submissions to ANVISA, the FDA and EU notified bodies, and follow how each authority applies the standard.
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 is reorganized around 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. The standard does not require re-testing devices already on the market with an established, acceptable safety profile. A documented review of the existing data shows whether new data are needed or whether the BEP and BER only need to be updated. 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 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
ISO 10993-1:2025 is the current international edition and the reference for new biological evaluations. How it is applied varies by market.
Get the free guide
Subscribe to our newsletter to receive the latest updates and insights.
You may unsubscribe at any time using the link in our newsletter.
