Full Description

Clause 1 of the general standard¹ applies, except as follows:

201.1.1 Scope

Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

Cross References:
EN 60601-1:2006
EN 60601-1:2006/A1:2013
EN 60601-1:2006/A11:2011
EN 60601-1:2006/A12:2014
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
EN 60601-1:2006/corrigendum Mar. 2010
IEC 60601-2-2:2017
EN IEC 60601-2-2:2018


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 06/04/2019 ISBN(s): 9780580933981 Number of Pages: 32 File Size: 1 file , 1.3 MB Product Code(s): 30337820, 30337820, 30337820 Note: This product is unavailable in United Kingdom