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NS-EN 13544-1:2007+A1:2009

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Omfang

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).

Dokumentinformasjon

  • Konsolidert fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2009-08
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.10
  • National Committee SN/K 122

Referanser i lov

EU lov:
Lov referanse Restriksjoner
2007/47/EC
93/42/EEC

Produktrelasjon

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