ISO 81060-2:2018
Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
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.
This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for clinical investigations
4.1 Clinical investigation methods
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
5.1.3 * Age distribution
5.1.4 * Limb size distribution
5.1.5 Blood pressure distribution
5.1.6 * Special patient populations
5.2 Clinical investigation method with a reference sphygmomanometer
5.2.1 * Subject preparation
5.2.2 * Observer preparation
5.2.3 * Reference readings
5.2.4 Clinical investigation methods
5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments
5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring
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
6.1.4 Limb size distribution
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
6.2.2 * Arterial reference site
6.2.3 Procedure
6.2.4 * Determining the reference blood pressure
6.2.5 Determining the error of the blood pressure measurement
6.2.6 Data analysis
6.2.7 Mean arterial pressure (map)
7 * Pregnant patient populations
Annex A (informative) Rationale and guidance
Annex B (informative) Reference to the essential principles
Annex C (informative) Terminology — alphabetized index of defined terms
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for clinical investigations
4.1 Clinical investigation methods
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
5.1.3 * Age distribution
5.1.4 * Limb size distribution
5.1.5 Blood pressure distribution
5.1.6 * Special patient populations
5.2 Clinical investigation method with a reference sphygmomanometer
5.2.1 * Subject preparation
5.2.2 * Observer preparation
5.2.3 * Reference readings
5.2.4 Clinical investigation methods
5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments
5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring
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
6.1.4 Limb size distribution
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
6.2.2 * Arterial reference site
6.2.3 Procedure
6.2.4 * Determining the reference blood pressure
6.2.5 Determining the error of the blood pressure measurement
6.2.6 Data analysis
6.2.7 Mean arterial pressure (map)
7 * Pregnant patient populations
Annex A (informative) Rationale and guidance
Annex B (informative) Reference to the essential principles
Annex C (informative) Terminology — alphabetized index of defined terms
Bibliography