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)

SS-EN-ISO-80601-2-13-AM1 - 2012 EDITION AMENDMENT 1 - CURRENT


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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:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)


Medical devices

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Designation Name

SS-EN ISO 80601-2-13:2012/A1:2019

Revision Level

2012 EDITION AMENDMENT 1

Status

Current

Publication Date

Nov. 29, 2019

Language(s)

English

Page Count

20

International Equivalent

EN ISO 80601-2-13:2012/A1:2019(IDT); ISO 80601-2-13:2011/Amd 1:2015(IDT)