CSA - CAN/CSA-C22.2 NO. 60601-1-8:08 AMD 1
Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-8:08 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
|Publication Date:||1 January 2014|
|ICS Code (Medical equipment in general):||11.040.01|
INTRODUCTION TO THE AMENDMENT
The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue has been identified with respect to pulse and burst testing. In addition, issues have been raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during implementation of alarm system requirements in particular standards within their scope of work.
At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3 Resolution Orebro 6, to develop the 1st amendment to IEC 60601-1-8:2006 to address the issues identified above. IEC/SC 62A - ISO/TC 121/SC 3 Joint Working Group 2, Alarms, was reactivated as a maintenance team to develop this amendment.