IEC 60601-2-4

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Body

IEC

Number

IEC 60601-2-4

Editions

2018

FDA recognition no.

3-169

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: -Subclause 201.107 - Requirements for Rhythm Recognition Detector -Clause 202 - Electromagnetic compatibility - Requirements and tests

Scope source: FDA 认可共识标准库

Laboratories covering this standard