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Medical electrical equipment. General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests
BS EN 60601-1-2 covers the general requirements and tests for safety of electromagnetic compatibility of medical electrical equipment and systems.
This European Standard specifies requirements and tests for electromagnetic compatibility of equipment and systems and serves as the basis of electromagnetic compatibility requirements and tests in particular standards.
This standard recognizes that for life-supporting equipment and systems, higher levels of immunity are necessary in order to establish a broader safety margin, even for use in the general medical use environment. Therefore, this standard specifies additional requirements for life-supporting equipment and systems.
This second edition allows a risk analysis to be used to determine the essential performance and safety of medical electrical equipment to be examined during immunity testing and whether testing according to this standard is required for non medical electrical equipment that is combined with medical electrical equipment to form a system.
History and related standards
This European Standard supersedes BS EN 60601-1-2:1993, which is withdrawn.
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