EN 1282-2:2005+A1:2009: Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
DIN EN 1282-2:2009-12 (E)
Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified) (includes
Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Size designation and dimensions ……………………………………………………………………………………6
4.1 Designation of size of tube ……………………………………………………………………………………………..6
4.2 Outside diameter …………………………………………………………………………………………………………….6
4.3 Length ……………………………………………………………………………………………………………………………7
4.4 Angle ……………………………………………………………………………………………………………………………..8
5 Materials …………………………………………………………………………………………………………………………8
6 Design and finish ……………………………………………………………………………………………………………8
6.1 Machine end ……………………………………………………………………………………………………………………8
6.2 Paediatric tracheostomy tube connector …………………………………………………………………………8
6.3 Inner tube ……………………………………………………………………………………………………………………….9
6.4 Neck-plate …………………………………………………………………………………………………………………….10
6.5 Cuff ………………………………………………………………………………………………………………………………10
6.6 Inflating tubes for cuffs …………………………………………………………………………………………………10
6.7 Patient end ……………………………………………………………………………………………………………………10
6.8 Introducer ……………………………………………………………………………………………………………………..10
7 Requirements for tracheostomy tubes supplied sterile …………………………………………………..11
7.1 Sterility assurance ………………………………………………………………………………………………………..11
7.2 Packaging for tracheostomy tubes supplied sterile ………………………………………………………..11
8 Marking …………………………………………………………………………………………………………………………11
8.1 Marking of tracheostomy tube ……………………………………………………………………………………….11
8.2 Marking of tracheostomy tube connectors …………………………………………………………………….11
8.3 Marking of unit packs ……………………………………………………………………………………………………11
9 Adaptor …………………………………………………………………………………………………………………………13
Annex A (normative) Test for security of attachment of permanently attached connector, if
provided, and neck-plate to tracheostomy tube ……………………………………………………………..14
A.1 Principle ……………………………………………………………………………………………………………………….14
A.2 Apparatus ……………………………………………………………………………………………………………………..14
A.3 Procedure ……………………………………………………………………………………………………………………..14
A.4 Expression of results …………………………………………………………………………………………………….15
Annex B (normative) Test method for determining the resting diameter of the cuff ………………………..16
B.1 Principle ……………………………………………………………………………………………………………………….16
B.2 Apparatus ……………………………………………………………………………………………………………………..16
B.3 Procedure ……………………………………………………………………………………………………………………. 16
B.4 Expression of results …………………………………………………………………………………………………… 16
Annex C (informative) Guidance on materials and design ……………………………………………………………. 17
C.1 Materials ……………………………………………………………………………………………………………………… 17
C.2 Design …………………………………………………………………………………………………………………………. 17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices …………………………………………….. 18
Bibliography ……………………………………………………………………………………………………………………………….. 20