IEC 60601-2-25

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

Body

IEC

Number

IEC 60601-2-25

Editions

2011

FDA recognition no.

3-105

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: - Subclause 201.12.1.101.2 Requirements for amplitude measurements - Subclause 201.12.1.101.3.1 Requirements for absolute interval and wave duration measurements - Subclause 201.12.1.101.3.2 Requirements for interval measurements on biological ECGs - 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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