The scope given in clause 1 of EN 60601-1:1990 applies with the following addition: This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use. This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e. g. gas powered ventilators) through to devices for pre-planned longer term use. This includes gas-powered resuscitators, which are generally used by first responders. This part does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations. Additional parts, e. g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.
EN 794-3:1998+A2:2009 Referenced Document
EN 1281-1:1997 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets (Incorporates Amendment A1: 1998)
EN 1281-2:1995 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw-Threaded Weight-Bearing Connectors (ISO 5356-2 : 1987 Modified)
EN 475:1995 Medical Devices - Electrically-Generated Alarm Signals
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 737-1:1998 Medical Gas Pipeline Systems - Part 1: Terminal Units for Compressed Medical Gases and Vacuum
EN 738-1:1997 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices (Incorporates Amendment A1: 2002)
EN 739:1998 Low-pressure hose assemblies for use with medical gases Includes Amendment A1: 2002
EN 794-3:1998+A2:2009 history
2009EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
1998EN 794-3:1998 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators (Incorporates Amendment A2: 2009)