IEC 60601-1-11

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Body

IEC

Number

IEC 60601-1-11

Editions

2020

FDA recognition no.

19-38

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: "Note 2 to entry" in Sub-clause 3.1 (Home Healthcare Environment).

Scope source: FDA 认可共识标准库

Laboratories covering this standard