ISO 10993-1 Biological Evaluation of Medical Devices - Evaluation and Testing in a Risk Management Process

Evaluations to determine the biological risks of medical devices are defined in ISO 10993 and product-specific standards, and the selection of applicable tests depends on the device.

According to the introduction of this standard, “this document is not intended to provide a strict set of test methods, including pass/fail criteria, as this may unduly restrict the development and use of new medical devices.

The ISO 10993-1 series is designed for use by suitably qualified professionals with training and experience, who can interpret the requirements and judge the outcome of the evaluation for each medical device, taking into account all medical device-related factors.

This standard states:

• General principles governing the biological evaluation of medical devices within a risk management process;
• General classification of medical devices according to the nature and duration of their contact with the body;
• Evaluation of relevant data available from all sources;
• Identifying gaps in the existing dataset based on a risk analysis;
• Identifying additional datasets necessary to analyze the biological safety of the medical device;
• Evaluation of the biological safety of the medical device.

This standard applies to the evaluation of materials and medical devices that are expected to come into direct or indirect contact with:

• the patient's body during its intended use;
• The user's body if the medical device is for protection (for example, surgical gloves, masks and others).

This standard is applicable to the biological evaluation of all types of medical devices, including active, inactive, implantable and non-implantable medical devices.

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