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  • BSI
    19/30408758 DC BS EN ISO 81060-3. Non-invasive sphygmomanometers - Part 3. Clinical investigation of continuous automated measurement type
    Edition: 2019
    $42.22
    / user per year

Description of 19/30408758 DC 2019

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.



Standard Number19/30408758 DC
TitleBS EN ISO 81060-3. Non-invasive sphygmomanometers - Part 3. Clinical investigation of continuous automated measurement type
StatusDefinitive
Publication Date2019-12-23
Identical National Standard OfISO/DIS 81060-3
DescriptorsPressure measurement (fluids), Verification, Automatic, Blood pressure, Medical equipment, Clinical testing, Accuracy, Performance, Flow, Clinical investigation instruments, Measurement, Medical instruments, Electrical medical equipment, Clinical investigation, Cuffs, Sphygmomanometers
ICS11.040.10 Anaesthetic, respiratory and reanimation equipment, 11.040.55 Diagnostic equipment
CommitteeCH/205/10
PublisherBSI
Pages42

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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