BS ISO 81060-2:2009 Non-invasive sphygmomanometers. Clinical validation of automated measurement type
BS ISO 81060-2 specifies the requirements and methods for the clinical validation of me equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff.
BS ISO 81060-2 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.
BS ISO 81060-2 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 or self-measurement)
BS ISO 81060-2 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this part of ISO 81060.
BS ISO 81060-2 is not applicable to the validation of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
Contents of BS ISO 81060-2:
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for validation studies
4.1 Validation methods
4.2 Ethical requirements
5 Validation with auscultatory reference sphygmomanometer
5.1 Subject requirements
5.2 Validation method with reference sphygmomanometer
6 Validation with reference invasive blood pressure monitoring equipment
6.1 Patient requirements
6.2 Validation methods with reference invasive blood pressure monitoring equipment
7 * Pregnant, including pre-eclamptic, patient populations
Annex A (informative) Rationale
Annex B (normative) Target heart rates for exercise stress testing
Annex C (informative) Reference to the essential principles
Annex D (informative) Terminology — Alphabetized index of defined terms
Bibliography
ISO 81060-2:2009/Cor 1:2011