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EN 13544-1:2007/A1:2009 Standard

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  Keywords:

#powered #nebulizers #european #standard #used

  Directive

Medical devices Directive (93/42/EEC)

  Description:

Respiratory therapy equipment - Part 1: Nebulizing systems and their components

  Purpose

This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic and membrane devices) or manually-powered nebulizers.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 13544-1:2007"

  Reference

This standard supersedes the "EN 13544-1:2007"

Anyway is still possible use the "EN 13544-1:2007" until March 21st, 2010

  Related Standards

EN 60601-2-25:1995

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Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN ISO 22675:2016

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Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

EN 27740:1992/A1:1997

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN ISO 26782:2009/AC:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

EN ISO 23747:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously brea...

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