Need help?

EN 794-3:1998/A2:2009 Standard

wave
Save  

  Keywords:

#powered #use #resuscitators #ventilators #devices

  Directive

Medical devices Directive (93/42/EEC)

  Description:

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

  Purpose

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.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 794-3:1998"

  Reference

This standard supersedes the "EN 794-3:1998"

Anyway is still possible use the "EN 794-3:1998" until March 21st, 2010

  Related Standards

EN 80601-2-35:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating device...

EN 1618:1997

Medical devices Directive (93/42/EEC)

Catheters other than intravascular catheters - Test methods for common properties

EN ISO 80601-2-55:2018

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory ga...

EN 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-3:2006

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 794-3:1998/A2:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0