IEC 60601-1-4 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
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IEC 60601-1-4 Document Information:
Title
Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
Appareils Electromedicaux - Partie 1-4: Regles Generales De Securite - Norme Collaterale: Systemes Electromedicaux Programmables
International Electrotechnical Commission
Publication Date:
Apr 1, 2000
Scope:
This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).
NOTE Some systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 60601-1 or the definition of MEDICAL ELECTRICAL SYSTEM in 2.203 of IEC 60601-1-1.
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