SR EN ISO 80601-2-13:2022
Aparate electromedicale. Partea 2-13: Cerinţe particulare pentru securitatea de bază şi performanțele esenţiale ale unei stații de lucru pentru anestezie
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
Status :
In vigoare
Data aprobării : 29.07.2022
Număr de pagini : 116
ICS : 11.040.10 Echipament pentru anestezie, respiratie si reanimare
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 80601-2-13:2013
- Inlocuieste SR EN ISO 80601-2-13:2013/A1:2020
- Inlocuieste SR EN ISO 80601-2-13:2013/A2:2020
EN