BS EN 13544-3:2001+A1:2009 - Respiratory therapy equipment. Air entrainment devices – BSI British Standards

BS EN 13544-3:2001+A1:2009

Respiratory therapy equipment. Air entrainment devices

Status : Current, Project Underway   Published : July 2001



BS EN 13544-3:2001+A1:2009 Respiratory therapy equipment. Air entrainment devices

BS EN 13544-3 specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device.

BS EN 13544-3 also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration.

BS EN 13544-3 does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

Contents of BS EN 13544-3:

1 Scope
2 Normative references
3 Terms and definition
3.1 Air entrainment device
4 Oxygen supply
5 Connections
5.1 Oxygen supply inlet
5.2 Air inlet attachments
6 Delivered oxygen concentration
7 Marking and identification
7.1 Marking
7.2 Colour coding
8 Information supplied by the manufacturer
9 Usability
10 Clinical evaluation
Annex A (normative) Method of test for delivered oxygen concentration
Annex B (informative) Rationale
Annex C (informative) Colour coding
Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"


Standard NumberBS EN 13544-3:2001+A1:2009
TitleRespiratory therapy equipment. Air entrainment devices
StatusCurrent, Project Underway
Publication Date15 July 2001
Normative References(Required to achieve compliance to this standard)EN 1041, EN 738-1, prEN 13159, EN ISO 4135, EN 980
Informative References(Provided for Information)93/42/EEC, EN 60601-1-6, EN 62366, prEN 13544-2, BS 381C:1988
ReplacesBS 7711-2:1994
International RelationshipsEN 13544-3:2001+A1:2009
Amended ByAmendment, March 2010
Draft Superseded By09/30192045 DC
DescriptorsSafety measures, Medical equipment, Air control devices, Oxygen, Colour codes, Breathing apparatus, Identification methods, Performance, Inhalation therapy equipment, Concentration (chemical), Medical breathing apparatus, Marking, Respirators
Title in FrenchAppareils de thérapie respiratoire. Dispositifs d'entraînement d'air
Title in GermanAtemtherapiegeräte. Luftbeimischgeräte
ISBN978 0 580 65094 9
File Size586 KB

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