SS-EN-ISO-80601-2-13-AM1 › Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
The following bibliographic material is provided to assist you with your purchasing decision:
EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards: addition of a definition on interchangeable anaesthetic vapour delivery system; marking the mass of mobile me equipment; movement over a threshold; rough handling test; multiple socket-outlets; specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use; vapour concentration during and after oxygen flush; inspiratory pause. Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:UL-94
Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
Medical devices. Quality management systems. Requirements for regulatory purposes
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SS-EN ISO 80601-2-13:2012/A1:2019
2012 EDITION AMENDMENT 1
Nov. 29, 2019
EN ISO 80601-2-13:2012/A1:2019(IDT); ISO 80601-2-13:2011/Amd 1:2015(IDT)