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SR EN 13544-1+A1:2010

Echipament de terapie respiratorie. Partea 1: Sisteme de nebulizatoare şi componentele lor

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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Status : Anulat
Data aprobării : 29.01.2010
Data publicării : 31.01.2010
Data anulării : 31.01.2020
Număr de pagini : 44
ICS : 11.040.10 Echipament pentru anestezie, respiratie si reanimare
Comitet tehnic : 377 - Medicale

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