DS/EN ISO 80601-2-61:2011
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Standard No.

DS/EN ISO 80601-2-61:2011

Release Date

2011

Published By

Danish Standards Foundation

Latest

DS/EN ISO 80601-2-61:2011

Replace

DS/EN ISO 9919:2009

Scope

ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare in

DS/EN ISO 80601-2-61:2011 history

• 2011 DS/EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
• 0000 DS/EN ISO 9919:2009