IEC 60601-2-27

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]

Body: IEC
Number: IEC 60601-2-27
Editions: 2011
FDA recognition no.: 3-126

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: - Subclause 202.6.2.6.1 Requirements, bb) exemption of patient cables

Scope source: FDA 认可共识标准库

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