Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
|Publication Date:||1 May 2003|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
This Particular Standard specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use in an ANAESTHETIC SYSTEM.
This Particular Standard does not apply to:
- ANAESTHETIC SYSTEM(S) intended for use with flammable anaesthetic agents, as determined by Annex DD,
- portable ANAESTHETIC SYSTEM(S) for use in remote sites, open fields for rescue operations or in disaster areas,
- dental analgesia apparatus.