Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type

Designation Number:
CSA ISO 81060-2:19
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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.

Project need:

To review the Standard within the required 5 year period.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.