In addition, the pulse rate set on the NIBP simulator is tested.

This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).

NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.

This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.

NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.

This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.

No requirements for monitoring the equipment are given in ISO/TS 18835:2004.

— gas-powered resuscitator as specified in ISO 10651-5[1] [1];

— operator-powered resuscitator as specified in ISO 10651-4[2];

— ventilator for critical care as specified in ISO 80601-2-12[3] [2];

— ventilator for emergency medical services environment as specified in ISO 80601-2-84[4] [3], the future replacement for ISO 10651-3[5];

NOTE 1 ISO 80601-2-84 updates the content of ISO 10651-3 and harmonizes it with IEC 60601-1:2005+AMD1:2012[6] and IEC 60601-1-12:2014[7].

— ventilator for ventilatory impairment in the home healthcare environment as specified in ISO 80601-2-79[8];

— ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISO 80601-2-80[9];

— ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISO 80601-2-72[10];

— sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11].

NOTE 2 Sleep apnoea breathing therapy equipment is not considered to be an artificial ventilator. It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing therapy equipment is not considered a ventilator.

This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator.

[1] Numbers in square brackets refer to the Bibliography.

[2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.

[3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

Amendment (add at the end of 1.1):

ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.

These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has 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 on patients in healthcare institutions as well as on patients in home care.

ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.

ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use.

ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO₂ values that are located outside of the patient environment.

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.