I.S. EN ISO 80601-2-61:2019&LC:2019
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017)
Hardcopy , PDF
English
04-25-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.
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