EN 1782:1998+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Tracheal tubes and connectors
19-08-2009
01-10-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements for tracheal tubes
and tracheal tube connectors
5 Additional requirements for tracheal tubes
with a Murphy eye
6 Requirements for tracheal tubes and tracheal
tube connectors supplied sterile
7 Marking
Annex A (normative) - Test method for determining
the resting diameter of the cuff
Annex B (normative) - Test method for tube collapse
Annex C (normative) - Test method for cuff herniation
Annex D (informative) - Guidance on materials and design
Annex E (informative) - Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the
Essential Requirements of
EU Directive 93/42/EEC
This European Standard specifies requirements for oro-tracheal and naso-tracheal tubes (plain and cuffed) made of plastics materials and/or rubber and requirements for tracheal tube connectors. Specialized tubes are excluded from the scope of this standard.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
1998 Edition Re-issued in August 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 1782 : 1998 + A1 2009 | Identical |
| I.S. EN 1782:1998 | Identical |
| NF EN 1782 : 1998 + A1 2009 | Identical |
| PN EN 1782 : 2006 + A1 2010 | Identical |
| DIN EN 1782:2009-12 | Identical |
| NS EN 1782 : 1998 + A1 2009 | Identical |
| BS EN 1782 : 1998 | Identical |
| NBN EN 1782 : 1998 + A1 2009 | Identical |
| BS EN 1782:1998+A1:2009 | Equivalent |
| UNE-EN 1782:1998 | Identical |
| UNE-EN 1782:1998+A1:2010 | Identical |
| BS EN 1782:1998+A1:2009 | Identical |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| DIN EN 1733:2003-02 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| I.S. EN 1733:2002 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| PREN ISO 15883-2 : DRAFT 2002 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| EN 1733 : 2002 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| 03/700194 DC : DRAFT FEB 2003 | BS EN ISO 15883-2 - WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC. |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 1733:2002 | Suction catheters for use in the respiratory tract |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN 1281-1:1997/A1:1998 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS |
| ISO/TR 11991:1995 | Guidance on airway management during laser surgery of upper airway |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| EN 30993-1 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS |