IEC 60601-2-2

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Body

IEC

Number

IEC 60601-2-2

Editions

2017、2023

FDA recognition no.

6-389

FDA recognition no.

6-521

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Subclause 202.7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS Subclause 202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS

Scope source: FDA 认可共识标准库

Laboratories covering this standard