IEC 80601-2-49

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

Body
IEC
Number
IEC 80601-2-49
Editions
2024
FDA recognition no.
3-203

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Subclause 202.8.101 "IMMUNITY test setup" - Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101.

Scope source: FDA 认可共识标准库

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