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BS EN ISO 81060-2:2019+A1:2020

BS EN ISO 81060-2:2019+A1:2020

$189.07

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

Published By Publication Date Number of Pages
BSI 2020 48
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This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.

This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.

This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).

EXAMPLE Automated sphygmomanometer as given in IEC 80601‑2‑30 undergoing clinical investigation according to this document.

This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.

This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060‑1 or invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
5 Anchor 21
Foreword to amendment A1
6 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
4 General requirements for clinical investigations
4.1 Clinical investigation methods
13 4.2 Good clinical practice
4.3 Status of previous clinical investigations
4.4 Disclosure of summary of clinical investigation
5 Clinical investigation with an auscultatory reference sphygmomanometer
5.1 Subject requirements
5.1.1 * Number
5.1.2 * Gender distribution
14 5.1.3 * Age distribution
5.1.4 * Limb size distribution
15 5.1.5 Blood pressure distribution
5.1.6 * Special patient populations
16 5.2 Clinical investigation method with a reference sphygmomanometer
5.2.1 * Subject preparation
5.2.2 * Observer preparation
5.2.3 * Reference readings
18 5.2.4 Clinical investigation methods
25 5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments
26 5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring
27 6 Clinical investigation with reference invasive blood pressure monitoring equipment
6.1 Patient requirements
6.1.1 Number
6.1.2 * Gender distribution
6.1.3 * Age distribution
28 6.1.4 * Limb size distribution
29 6.1.5 Blood pressure distribution
6.1.6 Special patient populations
6.2 Clinical investigation methods with reference invasive blood pressure monitoring equipment
6.2.1 * Reference measurement
30 6.2.2 * Arterial reference site
31 6.2.3 Procedure
6.2.4 * Determining the reference blood pressure
32 6.2.5 Determining the error of the blood pressure measurement
6.2.6 Data analysis
33 6.2.7 Mean arterial pressure (map)
7 * Pregnant patient populations
35 Annex A (informative) Rationale and guidance
43 Annex B (informative) Reference to the essential principles
44 Annex C (informative) Terminology — alphabetized index of defined terms
45 Bibliography

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BS EN ISO 81060-2:2019+A1:2020
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