Standard Svensk standard · SS-EN ISO 80601-2-13:2012/A2:2019

Elektrisk utrustning för medicinskt bruk - Del 2-13: Särskilda krav på grundläggande säkerhet och funktion för anestesiarbetsstationer - Tillägg 2 (ISO 80601-2-13:2011/Amd 2:2018)

Status: Gällande

Köp denna standard

Standard Svensk standard · SS-EN ISO 80601-2-13:2012/A2:2019

Elektrisk utrustning för medicinskt bruk - Del 2-13: Särskilda krav på grundläggande säkerhet och funktion för anestesiarbetsstationer - Tillägg 2 (ISO 80601-2-13:2011/Amd 2:2018)
Prenumerera på standarden - Läs mer Dölj
Pris: 435 SEK
standard ikon pdf

PDF

Pris: 435 SEK
standard ikon

Papper

Pris: 696 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ
Omfattning
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.

Ämnesområden

Utrustning för anestesi, respiration och återupplivning (11.040.10)


Köp denna standard

Standard Svensk standard · SS-EN ISO 80601-2-13:2012/A2:2019

Elektrisk utrustning för medicinskt bruk - Del 2-13: Särskilda krav på grundläggande säkerhet och funktion för anestesiarbetsstationer - Tillägg 2 (ISO 80601-2-13:2011/Amd 2:2018)
Prenumerera på standarden - Läs mer Dölj
Pris: 435 SEK
standard ikon pdf

PDF

Pris: 435 SEK
standard ikon

Papper

Pris: 696 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Anestesi- och respiratorutrustning, SIS/TK 329

Internationell titel: Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)

Artikelnummer: STD-80018323

Utgåva: 1

Fastställd: 2019-11-29

Antal sidor: 12

Tillägg till: SS-EN ISO 80601-2-13:2012