SR EN 13544-1+A1:2010

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

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).

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General information

Status : Withdrawn
Approval date : 1/29/2010
Publish date : 1/31/2010
Withdrawal date : 1/31/2020
Number of pages : 44
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 13544-1:2007
Replaced by SR EN ISO 27427:2020