<p>For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.</p>
<p><i>Amendment (add at the end of 1.1):</i></p>
<p>ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of <b>pulse oximeter equipment </b>intended<b> </b>for use on humans. This includes any part necessary for <b>normal use</b>, e.g. the <b>pulse oximeter monitor</b>, <b>pulse oximeter probe</b>, <b>probe cable extender</b>.</p>
<p>These requirements also apply to <b>pulse oximeter equipment,</b> including <b>pulse oximeter monitors</b>, <b>pulse oximeter probes</b> and <b>probe cable extenders,</b> that has been <b>reprocessed</b>. </p>
<p>The intended use of <b>pulse oximeter equipment</b> includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on <b>patients</b> in healthcare institutions as well as on <b>patients</b> in home care. </p>
<p>ISO 9919:2005 is not applicable to <b>pulse oximeter equipment</b> intended for use in laboratory research applications nor to oximeters that requires a blood sample from the <b>patient</b>.</p>
<p>ISO 9919:2005 is not applicable to <b>pulse oximeter equipment</b> solely intended for fetal use.</p>
<p>ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display <b>SpO</b><sub>2</sub> values that are located outside of the <b>patient environment</b>.</p>
<p>The requirements of ISO 9919:2005 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.</p>
Registration number (WIID)
33780
Scope
<p>For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.</p>
<p><i>Amendment (add at the end of 1.1):</i></p>
<p>ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of <b>pulse oximeter equipment </b>intended<b> </b>for use on humans. This includes any part necessary for <b>normal use</b>, e.g. the <b>pulse oximeter monitor</b>, <b>pulse oximeter probe</b>, <b>probe cable extender</b>.</p>
<p>These requirements also apply to <b>pulse oximeter equipment,</b> including <b>pulse oximeter monitors</b>, <b>pulse oximeter probes</b> and <b>probe cable extenders,</b> that has been <b>reprocessed</b>. </p>
<p>The intended use of <b>pulse oximeter equipment</b> includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on <b>patients</b> in healthcare institutions as well as on <b>patients</b> in home care. </p>
<p>ISO 9919:2005 is not applicable to <b>pulse oximeter equipment</b> intended for use in laboratory research applications nor to oximeters that requires a blood sample from the <b>patient</b>.</p>
<p>ISO 9919:2005 is not applicable to <b>pulse oximeter equipment</b> solely intended for fetal use.</p>
<p>ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display <b>SpO</b><sub>2</sub> values that are located outside of the <b>patient environment</b>.</p>
<p>The requirements of ISO 9919:2005 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.</p>
