Skyddsutrustning

This document specifies the requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers used for the measurement of the blood pressure of a subject.

Since this document covers both trending devices and absolute accuracy devices and focuses solely on requirements for the clinical investigation, representation of output is not covered by this document.

NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices which can be used to clarify for the intended user whether the shown data concerns absolute accurate values or trending values.

The requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous non-invasive automated sphygmomanometers.

NOTE 2 Subject populations can, for example, be represented by age or weight ranges.

NOTE 3 Conditions of use can, for example, refer to ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment or self-measurement as well as use in professional healthcare facility or the emergency medical service environment (EMS).

This document specifies additional disclosure requirements for the accompanying documents of continuous non-invasive automated sphygmomanometers that have undergone clinical investigation according to this document.

This document is not applicable to the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, the clinical investigation of an intermittent automated sphygmomanometer as given in ISO 81060-2, an intermittent automated non-invasive sphygmomanometer as given in IEC 80601-2-30 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

This document gives guidance on the appropriate selection of fit testing methods and measurement, and provides practical guidance on fit testing methods, their uses and limitations.

This document does not specify the technical requirements for manufacturing fit testing equipment.