BS EN 794-3:1998+A2:2009
Lung ventilators - Particular requirements for emergency and transport ventilators

Standard No.

BS EN 794-3:1998+A2:2009

Release Date

1999

Published By

British Standards Institution (BSI)

Latest

BS EN 794-3:1998+A2:2009

Replace

95/562893 DC-1995 BS EN 794-3:1999

Scope

The scope given in clause 1 of EN 60601-1:1990 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 ational/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.

BS EN 794-3:1998+A2:2009 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)*， 2009-08-01 Update
• 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*， 1999-05-01 Update
• 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 62304 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)*， 2006-07-01 Update
• 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*， 2003-04-01 Update
• 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)*， 2009-04-01 Update
• IEC 60068-2-6 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)*， 2007-12-01 Update

BS EN 794-3:1998+A2:2009 history

• 1999 BS EN 794-3:1998+A2:2009 Lung ventilators - Particular requirements for emergency and transport ventilators
• 1999 BS EN 794-3:1999 Lung ventilators - Particular requirements for emergency and transport ventilators