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.