標(biāo)準(zhǔn)號(hào)：DIN EN 13544-1-2009
中文標(biāo)準(zhǔn)名稱：呼吸治療設(shè)備.第1部分:霧化系統(tǒng)及其部件,德文版本EN 13544-1:2007+A1:2009
英文標(biāo)準(zhǔn)名稱：Respiratory therapy equipment - Part 1: Nebulizing systems and their components; German version EN 13544-1:2007+A1:2009
標(biāo)準(zhǔn)類型：C46
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：2009/12/1 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C46
引用標(biāo)準(zhǔn)：EN 556;EN 737-1;ENV 737-6;EN 739;EN 980;EN 1041;EN 1281-2;EN 1707;EN 20594-1;EN 60601-1-1990;EN 60601-1-2;EN 60601-1-6;EN 61000-4-2-1995;EN 61672-1;EN 61672-2;EN 62304;EN 62366;EN ISO 3744;EN ISO 4135-2001;EN ISO 5356-1;EN ISO 7396-1;EN ISO 8185;EN ISO 10
適用范圍：This 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. This European Standard does not apply to nebulizers precharged with a specific medicinal product (e. g. MDI, DPI).