BS EN 13544-1-2007
呼吸治疗设备.雾化系统和其元部件
Respiratory therapy equipment - Nebulizing systems and their components
BS EN 13544-1-2007 发布历史
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).
BS EN 13544-1-2007由英国标准学会 GB-BSI 发布于 2007-05-31，并于 2007-05-31 实施。
BS EN 13544-1-2007 在中国标准分类中归属于: C46 手术室设备。
BS EN 13544-1-2007的历代版本如下：
- 2001年10月18日 BS EN 13544-1-2001 呼吸医疗设备.雾化系统及其元件
- 2007年05月31日 BS EN 13544-1-2007 呼吸治疗设备.雾化系统和其元部件
- 2007年05月31日 BS EN 13544-1-2007+A1-2009 呼吸治疗设备.雾化系统及其元部件
- 标准号
- BS EN 13544-1-2007
- 发布日期
- 2007年05月31日
- 实施日期
- 2007年05月31日
- 废止日期
- 无
- 中国标准分类号
- C46
- 发布单位
- GB-BSI
- 代替标准
- BS EN 13544-1-2007+A1-2009
- 适用范围
- 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).