StandardSwedish standard
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SS-EN 13544-1:2007+A1:2009
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
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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).
StandardSwedish standard
·
SS-EN 13544-1:2007+A1:2009
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions