ISO/TC 121/SC 3

Projekta Nr.ISO 80601-2-61:2026
Nosaukums<p><span lang="EN-GB">This</span><span lang="EN-GB"> 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.</span></p> <p><span lang="EN-GB">These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).</span></p> <p><span lang="EN-GB">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 institutions as well as patients in the home healthcare environment and the emergency medical services environment.</span></p> <p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.</span></p> <p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, </span><span lang="EN-GB">IEC 60601-1:2005+AMD1:2012+AMD2:2020,</span><span lang="EN-GB"> 7.2.13 and</span> <span lang="EN-GB">8.4.1.</span></p> <p><span lang="EN-GB">NOTE 2        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to pulse oximeter equipment intended solely for foetal use.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.</span></p> <p><span lang="EN-GB">NOTE 3        ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.</span></p>
Reģistrācijas numurs (WIID)84595
Darbības sfēra<p><span lang="EN-GB">This</span><span lang="EN-GB"> 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.</span></p> <p><span lang="EN-GB">These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).</span></p> <p><span lang="EN-GB">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 institutions as well as patients in the home healthcare environment and the emergency medical services environment.</span></p> <p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.</span></p> <p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, </span><span lang="EN-GB">IEC 60601-1:2005+AMD1:2012+AMD2:2020,</span><span lang="EN-GB"> 7.2.13 and</span> <span lang="EN-GB">8.4.1.</span></p> <p><span lang="EN-GB">NOTE 2        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to pulse oximeter equipment intended solely for foetal use.</span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.</span></p> <p><span lang="EN-GB">NOTE 3        ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. </span></p> <p><span lang="EN-GB">This</span><span lang="EN-GB"> document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.</span></p>
StatussStandarts spēkā
ICS grupa11.040.55
11.040.10