Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Designation Number:
CAN/CSA-C22.2 NO. 60601-1-8-08 (R2018)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.

It also provides guidance for the application of ALARM SYSTEMS.

201.1.1 *Scope

[Add the following paragraph]

 This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

Project need:

To align Canadian requirements with those of international standards in the medical electrical equipment subject area and update the current standard to user experience/feedback/new technology

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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.