This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document 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 (AGSS);
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.
NOTE 1
Monitoring equipment, alarm systems and
protection devices are summarized in Table AA.1.
An
anaesthetic workstation supplied complete and its individual components are considered as
ME equipment or
ME systems with regard to the general standard.
NOTE 2 The applicability of this document is indicated in Table AA.2.
This document 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 or its
accessories 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 including
accessories, as relevant.
Hazards inherent in the intended physiological function of an
anaesthetic workstation and its individual components including
accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any
anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
| File Size : | 1
file
, 1.9 MB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 05/01/2022 |
| Same As : | ISO 80601-2-13:2022 |
