NBN EN ISO 80601-2-13:2013

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

WITHDRAWN

About this standard

Languages
German, English and French
Type
NBN
Standards committee
CEN/TC 215
Status
WITHDRAWN
Publication date
22 February 2013
Replaces
NBN EN ISO 8835-4:2009, NBN EN ISO 8835-5:2009, NBN EN ISO 8835-2:2009, NBN EN ISO 8835-3:2009, NBN EN ISO 8835-3/A1:2010, NBN EN 60601-2-13:2007, NBN EN 60601-2-13/A1:2007
Replaced by
NBN EN ISO 80601-2-13:2022
Amended By
NBN EN ISO 80601-2-13:2012/A2:2019, NBN EN ISO 80601-2-13:2012/A1:2019
ICS Code
11.040.10 (Anaesthetic, respiratory and reanimation equipment)
Withdrawn Date
18 July 2022

About this training

Summary

ISO/ IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
ISO/ IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:

anaesthetic gas delivery system
anaesthetic breathing system
anaesthetic gas scavenging system
anaesthetic vapour delivery system
anaesthetic ventilator
monitoring equipment
alarm system
protection device.

ISO/ IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/ IEC 80601-2-13:2011 are not covered by specific requirements in ISO/ IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.
ISO/ IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.