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:
Foreword
Introduction
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
