<p>This document applies to <i>basic safety</i> and <i>essential performance </i>of <i>cerebral tissue oximeter equipment</i>, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the <i>probe</i> attached to the head. The <i>cerebral tissue oximeter equipment</i> can be based on continuous light, frequency domain or time domain technologies. This document applies to <i>ME equipment</i> used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to <i>ME equipment</i> for those environments of use.</p>
<p>NOTE 1 <i>Cerebral tissue oximeters</i> are sometimes referred to as near infrared spectroscopy equipment in medical literature.</p>
<p>Not included within the scope of this document are:</p>
<ul>
<li> invasive tissue or vascular oximeters; </li>
<li> oximeters that require a blood sample from the <i>patient</i>;</li>
<li> equipment measuring dissolved oxygen;</li>
<li> <i>ME equipment</i>, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71<sup>[4]</sup>;</li>
<li> <i>ME equipment</i>, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (<i>SpO<sub>2</sub></i>). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61<sup>[3]</sup>;</li>
<li> <i>ME equipment</i>, or any part thereof, that claims to monitor tissue in parts of the body other than the head.</li>
</ul>
<p>This document also applies to <i>cerebral tissue oximeter equipment</i>, including <i>cerebral tissue oximeter monitors</i>, <i>cerebral tissue oximeter probes</i> and <i>probe cable extenders</i>, that have been <i>remanufactured</i>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.</p>
<p>NOTE 2 See also 4.2 of the general standard. </p>
<p>This document can also be applied to <i>ME equipment</i> and their <i>accessories</i> used for compensation or alleviation of disease, injury or disability.</p>
<p>This document is not applicable to remote or slave (secondary) equipment that displays <i>StO</i><sub><i>2</i></sub> values that are located outside of the <i>patient environment</i>.</p>
<p>NOTE 3<i> ME equipment</i> that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. </p>
Registration number (WIID)
72442
Scope
<p>This document applies to <i>basic safety</i> and <i>essential performance </i>of <i>cerebral tissue oximeter equipment</i>, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the <i>probe</i> attached to the head. The <i>cerebral tissue oximeter equipment</i> can be based on continuous light, frequency domain or time domain technologies. This document applies to <i>ME equipment</i> used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to <i>ME equipment</i> for those environments of use.</p>
<p>NOTE 1 <i>Cerebral tissue oximeters</i> are sometimes referred to as near infrared spectroscopy equipment in medical literature.</p>
<p>Not included within the scope of this document are:</p>
<ul>
<li> invasive tissue or vascular oximeters; </li>
<li> oximeters that require a blood sample from the <i>patient</i>;</li>
<li> equipment measuring dissolved oxygen;</li>
<li> <i>ME equipment</i>, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71<sup>[4]</sup>;</li>
<li> <i>ME equipment</i>, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (<i>SpO<sub>2</sub></i>). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61<sup>[3]</sup>;</li>
<li> <i>ME equipment</i>, or any part thereof, that claims to monitor tissue in parts of the body other than the head.</li>
</ul>
<p>This document also applies to <i>cerebral tissue oximeter equipment</i>, including <i>cerebral tissue oximeter monitors</i>, <i>cerebral tissue oximeter probes</i> and <i>probe cable extenders</i>, that have been <i>remanufactured</i>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.</p>
<p>NOTE 2 See also 4.2 of the general standard. </p>
<p>This document can also be applied to <i>ME equipment</i> and their <i>accessories</i> used for compensation or alleviation of disease, injury or disability.</p>
<p>This document is not applicable to remote or slave (secondary) equipment that displays <i>StO</i><sub><i>2</i></sub> values that are located outside of the <i>patient environment</i>.</p>
<p>NOTE 3<i> ME equipment</i> that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. </p>
