Name: UNI EN 1782 : 2009
Brand: UNI

UNI EN 1782 : 2009

Superseded

View Superseded by

TRACHEAL TUBES AND CONNECTORS

Superseded date

02-21-2013

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

Describes requirements for oro-tracheal and naso-tracheal tubes (plain and cuffed) made of plastics materials and/or rubber and requirements for tracheal tube connectors.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5361 : 2013
Supersedes	UNI EN 1782 : 2000

Standards	Relationship
NEN EN 1782 : 1998 + A1 2009	Identical
I.S. EN 1782:1998	Identical
NF EN 1782 : 1998 + A1 2009	Identical
UNE-EN 1782:1998	Identical
EN 1782:1998+A1:2009	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
SN EN 1782 : 1998 + A1 2010	Identical

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
EN 20594-1:1993/A1:1997	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
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