CSA CAN/CSA-Z9919-07

Abstract

IEC 60601-1:1988, Clause 1 applies, except as follows. <br><em>Amendment (add at the end of 1.1):</em> <br>This International Standard specifies particular requirements for the basic safety and essential performance of <strong>pulse oximeter equipment</strong> intended for use on humans. This includes any part necessary for <strong>normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender</strong>. <br>These requirements also apply to <strong>pulse oximeter equipment</strong>, including pulse oximeter monitors, <strong>pulse oximeter probes</strong> and <strong>probe cable extenders,</strong> that has been <strong>reprocessed</strong>. <br>The intended use of <strong>pulse oximeter equipment</strong> includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on <strong>patients</strong> in healthcare institutions as well as on <strong>patients</strong> in home care. <br>* This International Standard is not applicable to <strong>pulse oximeter equipment</strong> intended for use in laboratory research applications nor to oximeters that requires a blood sample from the <strong>patient</strong>. <br>This International Standard is not applicable to <strong>pulse oximeter equipment</strong> solely intended for foetal use. <br>This International Standard is not applicable to remote or slave (secondary) devices that display <strong>SpO2</strong> values that are located outside of the <strong>patient environment</strong>. <br>The requirements of this International Standard which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.