CSA ISO 81060-2:19 (R2024)

CSA Preface

This is the second edition of CSA ISO 81060-2, Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 81060-2 (third edition, 2018-11). It supersedes the previous edition, published in 2014 as CAN/CSA-ISO 81060-2 (adopted ISO 81060-2:2013), Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type.

For brevity, this Standard will be referred to as “CSA ISO 81060-2” throughout.

This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee.

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope

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.