EN 1282-2:2005+A1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-3:2001, spremenjen)Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 1282-2:2005+A1:2009SIST EN 1282-2:2005+A1:2009en,de01-oktober-2009SIST EN 1282-2:2005+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1282-2:2005+A1
August 2009 ICS 11.040.10 Supersedes EN 1282-2:2005English Version
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)
Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert) This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1 approved by CEN on 16 July 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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....................................................................................................................................................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
1See ISO/TR 11991. SIST EN 1282-2:2005+A1:2009

Dimensions in millimetres
Designated size Inside diameterTolerance
2,0 2,0 +0,2 0
2,5 2,5
3,0 3,0
3,5 3,5
4,0 4,0
4,5 4,5 + 0,3 0
5,0 5,0
5,5 5,5
6,0 6,0 4.2 Outside diameter 4.2.1 The outside diameter (OD) of sections A and C (see Figure 1) of the tube, other than at the cuff if provided, shall be expressed in millimetres to the nearest 0,1 mm. NOTE
The marked outside diameter relates to that portion of the tube intended to be within the wall and lumen of the trachea. 4.2.2 The actual outside diameter of section A, other than at the cuff if provided, shall be the marked outside diameter subject to a tolerance of ± 0,2 mm. 4.2.3 The actual outside diameter of section C shall be the marked outside diameter subject to a tolerance of
± 0,5 mm. SIST EN 1282-2:2005+A1:2009

a) Paediatric tracheostomy tube
b) Patient end Key 1
Neck-plate 2
Datum plane 3
Tip rounded 4
Bevel, if present a Obtuse angle formed between the long axes of the tube at the machine and patient ends. Figure 1 — Basic dimensions of paediatric tracheostomy tubes 4.3 Length 4.3.1 The nominal length (l1 + l2 + l3 in Figure 1) shall be measured from the patient side of the neck-plate to the patient end, including the bevel if present (see Figure 1), and expressed in millimetres. 4.3.2 The actual nominal length (l1 + l2 + l3 in Figure 1) shall be the marked nominal length subject to a tolerance of ± 1,5 mm for tubes with a marked inside diameter of less than 4,5 mm, or subject to a tolerance of ± 2 mm for tubes with a marked inside diameter of 4,5 mm or greater. SIST EN 1282-2:2005+A1:2009

Dimensions l1 and/or l2 can be, or approach, zero. 4.4 Angle
The angle
(see Figure 1) shall be expressed in degrees. 5 Materials Tracheostomy tubes, including cuffs and tracheostomy tube connectors provided with the tube, in their ready-for-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in EN ISO 10993-1. !NOTE 1" See Annex C for guidance on materials and design. !If phthalates are incorporated in parts
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