SNV - SN EN ISO 80601-2-13
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
|Publication Date:||1 March 2013|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
This International Standard 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 International Standard 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.
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 International Standard is indicated in Table AA.2.
This International Standard 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.