ANSI/AAMI/ISO 81060-2:2019 pdf download.Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type.
This part of ISO 81060 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.
This part of ISO 81060 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 part of ISO 81060 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).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 validated by this part of ISO 81060.
This part of ISO 81060 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this part of ISO 81060.
This part of ISO 81060 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14155:- _1), Clinical investigation of medical devices for human subjects - - Good clinical practice
ISO 81060-1:2007, Non-invasive sphygmomanometers 一Part 1: Requirements and test methods for non-automated measurement type
IEC 80601-2- 30:2009, Medical electrical equipment一Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care applications
IEC 60601-2-34:2000, Medical electrical equipment一Part 2 34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14155, IEC 80601-2-30, IEC 60601-1，IEC 60601-1-11，IEC 60601-2-34 and the following apply. For convenience， an alphabetized list of the sources of all defined terms used in this document is given in Annex D.
3.1 reference
established accuracy used for clinical evaluation of other instruments
3.2 sphygmomanometer
me equipment for non-invasive estimation of systemic arterial blood pressure
3.3 sphygmomanometer-under-test
sphygmomanometer being clinically evaluated
4 General requirements for validation studies
4.1 Validation methods
Sphygmomanometers other than non-automated sphygmomanometers shall be clinically validated either. by using a non-invasive (auscultatory) reference sphygmomanometer or by using reference invasive blood pressure monitoring equipment according to this part of ISO 81060 in each mode of operation.
EXAMPLE 1 Adult and neonatal mode.
EXAMPLE 2 Slow and fast cuff deflation rate mode.
A clinical validation study shall be considered a type test.
Consider compliance with the requirements of this subclause to exist when the criteria of the relevant inspections and tests in this part of ISo 81060 are met.ANSI/AAMI/ISO 81060-2 pdf download.