ISO 10993-1:2025—Biological Evaluation of Medical Devices

Medical devices range from simple bandages to complex implantable devices like pacemakers and prosthetics. Regardless of their complexity, all medical devices must undergo rigorous testing to assure they will not cause harm to patients when used as intended. One of the key steps in this process is the biological evaluation of medical devices, which assesses how materials used in devices interact with biological systems. ISO 10993-1:2025—Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process provides guidance and requirements for the biological evaluation of a medical device within a risk management process.

What Is ISO 10993-1:2025?

ISO 10993-1:2025 specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:

A patient’s body during intended use or reasonably foreseeable misuse; or
The body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks).

ISO 10993-1:2025 aims to protect humans from biological risks arising from the use of medical devices and the materials from which they are made.

You can learn more about ISO 14971 in our blog post: ISO 14971:2019–Risk Management To Medical Devices.

Biological Evaluation of Medical Devices

ISO 10993-1:2025 details that biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with:

Constituents of a medical device; and
Tissue-device interactions (including physical effects).

The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle.

The evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of ISO 10993-1:2025.

Why Is Biological Evaluation Important?

The primary goal of biological evaluation is to prevent harm to patients. Medical devices, especially those that are implanted or come into direct contact with the body, can present a risk if their materials are not properly assessed. For example, a pacemaker that causes an allergic reaction, or a wound dressing that induces skin irritation, can lead to serious complications, including infection, wound dehiscence, and organ failure. By conducting a thorough biological evaluation, manufacturers can assure that their products:

Are non-toxic: The materials used in a device should not release harmful substances that could negatively impact the body.
Are biocompatible: The device materials must interact with human tissues without causing an adverse immune response or inflammation.
Minimize patient discomfort: The device should not cause irritation or sensitization when it comes into contact with skin or mucosal surfaces.
Meet regulatory requirements: Regulatory bodies like the FDA (Food and Drug Administration) or EMA (European Medicines Agency) require evidence of biological safety before approving a device for market use.

Array of medical devices including bandages, surgical instruments, pacemakers, and prosthetics, illustrating the range of devices evaluated under ISO 10993-1:2025 for biological safety.

Where to Find ISO 10993-1:2025

Biological evaluation is a cornerstone of medical device development since it assures that products are safe, effective, and biocompatible for patient use. This intricate, multi-step process that requires careful planning, testing, and adherence to international standards like ISO 10993-1:2025.

ISO 10993-1:2025—Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process is available on the ANSI Webstore as well as in the following Standards Packages: