Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Standards Development Organisation:

Canadian Standards Association (operating as CSA Group)

Contact Information:

Canadian Standards Association (operating as CSA Group)

Working Program:

View the CSA work program

Designation Number:

CSA C22.2 NO. 80601-2-30

Standard Type:

National Standard of Canada - Adoption of International Standard

Standard Development Activity:

New Edition

Status:

Proceeding to development

SDO Comment Period Start Date:

2019-03-19

SDO Comment Period End Date:

2019-04-09

Posted On:

2019-03-12

Scope:

This second edition cancels and replaces the first edition published in 2009 and amendment 1:2013. This new edition constitutes a technical revisions

This edition includes the following significant technical changes with respect to the previous edition:

- Reference revision and Alignment with o IEC 60601-1:2005 + AMD1:2012 o IEC 60601-1-8:2006 + AMD1:2012 o IEC 60601-1-10:2007 o IEC 60601-1-12

- Changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series

- Added additional requirements for public self-use sphygmomanometers

- Added a list of primary operating functions.

Project need:

To maintain alignment with international requirements in the medical electrical equipment and update the current standard to meet new technology

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.