CEI EN 60601-1-8/A1 PDF

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.