BS EN ISO 80601-2-61:2019

201.1   Scope, object and related standards IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:

201.1.1   * Scope Replacement: 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 . 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