ISO 80601-2-61

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Body: ISO
Number: ISO 80601-2-61
Editions: 2017
FDA recognition no.: 1-139

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 201.12.1.101.1 SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT, Specification is not recognized.

Scope source: FDA 认可共识标准库

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