BS EN 1282-2:2005+A1:2009 - Tracheostomy tubes. Paediatric tubes – BSI British Standards

BS EN 1282-2:2005+A1:2009

Tracheostomy tubes. Paediatric tubes

Status : Current   Published : January 2010



BS EN 1282-2:2005+A1:2009 Tracheostomy tubes. Paediatric tubes

BS EN 1282-2 is a European Standard which specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given.

BS EN 1282-2 is not applicable to specialized tracheostomy tubes.

Contents of BS EN 1282-2:

1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design and finish
7 Requirements for tracheostomy tubes supplied sterile
8 Marking
9 Adaptor
Annex A (normative) Test for security of attachment of permanently attached connector, if provided, and neck-plate to tracheostomy tube
Annex B (normative) Test method for determining the resting diameter of the cuff
Annex C (informative) Guidance on materials and design
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices


Standard NumberBS EN 1282-2:2005+A1:2009
TitleTracheostomy tubes. Paediatric tubes
Publication Date31 January 2010
Normative References(Required to achieve compliance to this standard)EN 556-1:2001, EN ISO 5356-1, ISO 5356-1:2004, EN ISO 5366-1:2004, ISO 5366-1:2000, EN ISO 10993-1, ISO 10933-1:2003, EN 20594-1, ISO 5361, ISO 11607
Informative References(Provided for Information)ISO 4135, ISO/TR 11991, EN 980, EN 1041, 93/42/EEC
ReplacesBS EN 1282-2:1997
International RelationshipsEN 1282-2:2005
DescriptorsEndotracheal tubes, Tubing (medical), Anaesthetic equipment, Medical breathing apparatus, Medical equipment, Paediatrics, Plastics, Natural rubber, Synthetic rubber, Diameter, Size coding, Preferred sizes, Dimensions, Angles (geometry), Design, Packaging, Sterile equipment, Marking, Pull-out tests, Testing conditions
Title in FrenchTubes de trachéostomie. Tubes pédiatriques
Title in GermanTracheotomietuben. Pädiatrische Tuben
ISBN978 0 580 53770 7
File Size854.5 KB

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