EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

General information
Valid from 31.12.2020
Base Documents
ISO 10993-1:2018; EN ISO 10993-1:2020
Directives or regulations

Standard history

EN 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 EN 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.

EN ISO 10993-1 applies to 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 biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. EN 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 modification and it supersedes EN ISO 10993-1:2009.
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