DIN EN 794-3:2009
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators(includes Amendment A2:2009); English version of DIN EN 794-3:2009-12

Standard No.

DIN EN 794-3:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN 794-3:2009-12

Latest

DIN EN 794-3:2009-12

Replace

DIN EN 794-3/A1:2005 DIN EN 794-3:1998 DIN EN 794-3/A2:2009

Scope

The scope given in clause 1 of EN 60601-t:1990 applies with the following addition: 1.101 R) 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.

DIN EN 794-3:2009 Referenced Document

• EN 12342 Breathing tubes intended for use with anaesthetic apparatus and ventilators Incorporates Amendment A1: 2009
• EN 1281-1 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets (Incorporates Amendment A1: 1998)
• EN 1281-2 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw-Threaded Weight-Bearing Connectors (ISO 5356-2 : 1987 Modified)
• EN 1820 Anaesthetic reservoir bags (ISO 5362:2000, modified)
• EN 475 Medical Devices - Electrically-Generated Alarm Signals
• EN 550 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
• EN 552 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
• EN 554 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
• EN 556 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
• EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2015-09-01 Update
• EN 62304 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)
• EN 737-1 Medical Gas Pipeline Systems - Part 1: Terminal Units for Compressed Medical Gases and Vacuum
• EN 738-1 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices (Incorporates Amendment A1: 2002)
• EN 739 Low-pressure hose assemblies for use with medical gases Includes Amendment A1: 2002
• EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
• EN ISO 4135:1996 Anaesthesiology - Vocabulary (ISO 4135 : 1995)
• EN ISO 8185 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
• IEC 60068-2-6 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)

DIN EN 794-3:2009 history

• 2009 DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 / Note: DIN EN 794-3 (1998-10) remains valid alongside this standard until 2010-03-21.
• 2009 DIN EN 794-3:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators(includes Amendment A2:2009); English version of DIN EN 794-3:2009-12
• 0000 DIN EN 794-3/A1:2005
• 0000 DIN EN 794-3:1998