ISO 81060-2:2013
Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type
ISO 81060-2:2013 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.
ISO 81060-2:2013 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.
ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use.
ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
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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
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 determination
5.2.4 Clinical investigation methods
5.2.4.1 Same arm simultaneous method
5.2.4.1.1 * Procedure
5.2.4.1.2 * Data analysis
5.2.4.2 * Same arm sequential method
5.2.4.2.1 * Procedure
5.2.4.2.2 Data analysis
5.2.4.3 * Opposite limb simultaneous method
5.2.4.3.1 Procedure
5.2.4.3.2 * Data analysis
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
6.1.3.1 Sphygmomanometers intended for use in adults, adolescents or children
6.1.3.2 Sphygmomanometer for neonatal or infant populations
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 (including pre-eclamptic) patient populations
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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
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 determination
5.2.4 Clinical investigation methods
5.2.4.1 Same arm simultaneous method
5.2.4.1.1 * Procedure
5.2.4.1.2 * Data analysis
5.2.4.2 * Same arm sequential method
5.2.4.2.1 * Procedure
5.2.4.2.2 Data analysis
5.2.4.3 * Opposite limb simultaneous method
5.2.4.3.1 Procedure
5.2.4.3.2 * Data analysis
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
6.1.3.1 Sphygmomanometers intended for use in adults, adolescents or children
6.1.3.2 Sphygmomanometer for neonatal or infant populations
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 (including pre-eclamptic) patient populations