This supplementary standard applies to the safety of medical electrical equipment and medical electrical systems incorporating programmable electronic subsystems, hereinafter referred to as programmable electrical medical systems.
This supplemental standard specifies the requirements for the process by which a pems is designed. This assurance standard also serves as the basis for the requirements of certain standards, including serving as a guide to safety requirements for risk reduction and management.
This standard covers:
Matters not covered by this standard are:
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