ISO 10993-1 specifies:
— the general principles governing the biological evaluation of medical devices,
— the general categorization of medical devices,
— the assessment of the biological safety of the medical device.
The primary aim of ISO 10993-1 is the protection of humans from potential biological risks arising from the use of medical devices. The primary role is to serve as a framework in which to plan a biological evaluation. ISO 10993-1 applies to the evaluation of materials and medical devices that are expected to have direct or indirect contact with the patient's body or the user’s body (e.g., surgical gloves, masks).
It is applicable to the biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. ISO 10993-1 also gives guidelines for the assessment of biological hazards arising from risks, such as changes to the medical device over time, or breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. The text of ISO 10993-1:2018 has been approved in Europe as EN ISO 10993-1:2020 without any changes.
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