BS EN 13544-1:2007+A1:2009 - Respiratory therapy equipment. Nebulizing systems and their components

BS EN 13544-1:2007+A1:2009

Respiratory therapy equipment. Nebulizing systems and their components

Status : Superseded, Withdrawn   Published : May 2007 Replaced By : BS EN ISO 27427:2019

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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).




Standard NumberBS EN 13544-1:2007+A1:2009
TitleRespiratory therapy equipment. Nebulizing systems and their components
StatusSuperseded, Withdrawn
Publication Date31 May 2007
Withdrawn Date19 September 2019
Normative References(Required to achieve compliance to this standard)EN ISO 11137-1, IEC 60601-1-2:2007, ISO 4135:2001, ISO 11137-2:2006, EN ISO 8185, EN 1041, EN ISO 3744, EN ISO 17665-1, IEC 62304:2006, EN 556, EN ISO 10524-3, EN ISO 7396-1, EN ISO 11137-3, ISO 10524-3:2005, ISO 11137-3:2006, EN ISO 11135-1, ENV 737-6, ISO 17665-1:2006, IEC 60601-1:1988, IEC 61000-4-2:1995, EN 60601-1:1990, ISO 594-1:1986, EN 62304, IEC 60079-4, ISO 5356-2:1987, EN ISO 4135:2001, EN 62366, EN 20594-1, ISO 15001:2003, EN 1707, IEC 62366:2007, ISO 7396-1:2007, ISO 8185:2007, EN ISO 14971, IEC 61672-1:2002, EN 739, ISO 11135-1:2007, EN 1281-2, IEC 60601-1-6:2006, EN ISO 10524-1, IEC 61672-2:2003, EN ISO 5356-1, EN 61672-2, EN 60601-1-6, ISO 11137-1:2006, EN 61672-1, EN ISO 11137-2, ISO 10524-1:2006, ISO 3744:1994, ISO 5356-1:2004, EN 980, ISO 14971:2007, EN ISO 15001, EN 61000-4-2:1995, EN 60601-1-2, EN 737-1
Informative References(Provided for Information)ISO 9276-1:1998, NFPA 53M, 93/42 EEC, EN 552, ISO 9276-2:2001
Replaced ByBS EN ISO 27427:2019
ReplacesBS EN 13544-1:2001
International RelationshipsEN 13544-1:2007+A1:2009
Amended ByAmendment, April 2010
Draft Superseded By09/30189968 DC
DescriptorsBreathing apparatus, Performance testing, Respirators, Inhalation therapy equipment, Medical breathing apparatus, Nebulizers, Drug administration, Instructions for use, Environment (working), Medical equipment, Gas-powered devices, Aerosols, Hazards, Assembling, Manually-operated devices, Marking, Electrical equipment, Equipment safety
ICS11.040.10
Title in FrenchMatériel respiratoire thérapeutique. Systèmes de nébulisation et leurs composants
Title in GermanAtemtherapiegeräte. Verneblersysteme und deren Bauteile
CommitteeCH/121
ISBN978 0 580 64554 9
PublisherBSI
FormatA4
DeliveryYes
Pages46
File Size732 KB
Price£240.00


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