Tracheostomy tubes - Paediatric tubes

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