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BS EN ISO 81060-3:2022:2023 Edition

BS EN ISO 81060-3:2022:2023 Edition

$189.07

Non-invasive sphygmomanometers – Clinical investigation of continuous automated measurement type

Published By Publication Date Number of Pages
BSI 2023 48
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This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers 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. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2    Subject populations can, for example, be represented by age or weight ranges. NOTE 3    This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: ā€”    the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, ā€”    the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, ā€”     an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or ā€”    invasive blood pressure monitoring equipment as given in IEC 60601?2?34.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
12 4 General requirements for the clinical investigation
4.1 Good clinical practice
4.2 General
13 4.3 Reference method
4.3.1 Reference invasive blood pressure monitoring equipment
4.3.2 Subject requirements
15 4.3.3 Blood pressure distribution
16 4.3.4 Arterial reference site
17 4.4 Lateral difference
4.4.1 General
18 4.4.2 Sequential procedure
4.4.3 Simultaneous procedure
19 4.4.4 Application of lateral difference
4.5 Statistical considerations
4.5.1 General
20 4.5.2 Intra-class correlation coefficient and number of independent measurements
4.5.3 Procedure to derive the number of subjects and number of repeated paired measurements per subject
21 5 Methods for clinical investigation
5.1 Method for the accuracy of blood pressure determination
5.1.1 General
5.1.2 Procedure
5.1.3 Data analysis
22 5.1.4 Acceptance criteria
24 5.2 Method for stability
5.2.1 General
25 5.2.2 Procedure
5.2.3 Data analysis
27 5.2.4 Acceptance criteria
5.3 Method for blood pressure changes
5.3.1 Change evaluation interval
28 5.3.2 General
5.3.3 Procedure
5.3.4 Data analysis
30 5.3.5 Acceptance criteria
31 Annex A (informative) Rationale and guidance
43 Bibliography
44 Terminology ā€” alphabetized index of defined terms

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BS EN ISO 81060-3:2022
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