ISO 10993-1:2025
2025-11
ISO 10993-1:2025
What is ISO 10993-1?
ISO 10993-1 is the cornerstone standard for biological evaluation of medical devices. It defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971.
The standard guides manufacturers and evaluators through the process of identifying, assessing, and managing biological risks associated with materials, design choices, and tissue contact during a device’s intended use.
Why is ISO 10993-1 important?
Medical devices come into contact with the human body in countless ways, from implants and wound dressings to surgical tools and protective masks. Ensuring these devices are biocompatible is essential to protect patients and users from unintended biological harm.
ISO 10993-1 provides a consistent and science-based approach for evaluating these risks, helping manufacturers demonstrate biological safety, meet regulatory expectations, and reduce the need for unnecessary animal testing.
It underpins global market access by serving as the reference standard for biological safety evaluations used by regulators, notified bodies, and manufacturers worldwide.
Benefits
- Ensures patient and user safety through systematic biological risk assessment
- Supports global regulatory compliance and market approval
- Promotes efficient testing strategies and reduced animal use
- Facilitates early detection and control of potential biological hazards during design and development
- Aligns biological evaluation with the ISO 14971 risk-management process
FAQ
Manufacturers, designers, and evaluators of any medical device that comes into direct or indirect contact with the body — including implantable, surface-contacting, and externally communicating devices, as well as protective equipment such as gloves and surgical masks.
It’s the process of assessing how materials and components of a medical device interact with biological tissues. ISO 10993-1 helps determine whether a device’s materials are safe for their intended use, considering both composition and exposure duration.
The sixth edition has been completely reorganized to align with ISO 14971. It adds new guidance on exposure duration, materials characterization, and identification of biological hazards. Terminology has been updated for clarity, and new annexes explain the rationale behind these changes.
General information
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Status: PublishedPublication date: 2025-11Stage: International Standard published [60.60]
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Edition: 6Number of pages: 42
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Technical Committee :ISO/TC 194
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Complete medical device compliance essentials package
Your focused path to MDR/IVDR biological evaluation and risk management
- ISO 10993-1:2025 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- ISO 14971:2019 - Application of risk management to medical devices.
- ISO/TR 24971:2020 - Guidance on the application of ISO 14971.
Life cycle
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Previously
WithdrawnISO 10993-1:2018
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Now
