Consolidated

NS-EN 13544-1:2007+A1:2009

Nov 2009 Withdrawn

Corrigendums and amendments are bought separately.

Language English

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Abstract

The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:1.1 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.NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 "Humidifiers" (see 56.102).This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI).

Document information

Consolidated from SN
Published: 1 November 2009
Withdrawn: 1 December 2019
Edition: 2009-08
Version: 1
Document type: NAT
Pages
ISBN:

ICS 11.040.10
National Committee SN/K 122

Legal references

EU law:

Law reference	Restrictions
2007/47/EC
93/42/EEC

Product Relations

Replaced by: NS-EN ISO 27427:2019
Merges: NS-EN 13544-1:2007
Adopted from: EN 13544-1:2007+A1:2009, 0

Product life cycle

Current product

Withdrawn

NS-EN 13544-1:2007+A1:2009
Replaced by

Withdrawn

NS-EN ISO 27427:2019

NS-EN 13544-1:2007+A1:2009

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