BS EN 13544-1:2007 pdf free download.Respiratory therapy equipment – Part1:Nebulizing systems and their components.
This European Standard is based on EN 60601-1: 1990.
In EN 60601-1: 1990, this type of European Standard is referred to as a”Particular Standard” As stated in 1.3 of EN 60601-1: 1990 the requirements of this European Standard take precedence over those of EN 60601-1:1990.
Clauses, subclauses, tables and figures additional to those in EN 60601-1: 1990 are numbered beginning at “101”. Additional annexes are lettered beginning at ‘AA’ except for Annex ‘ZA’.
Additional items in lettered lists are lettered beginning ‘aa)’.
Rationales for some of the requirements of this European Standard are given in Annex AA. Such requirements are indicated by the letterR’after the clause number.
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 et, or electrically-powered nebulizers(e.g. ultrasonic and membrane device) or manually-powered nebulizers
Requirements for nebulizers having also a umidification 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 pdf download
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