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EN ISO 5361:2016

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Withdrawn date

30-09-2019

Published date

28-09-2016

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for tracheal tubes and
  tracheal tube connectors
5 Specific requirements for tracheal tubes and
  tracheal tube connectors
6 Additional requirement for tracheal tubes
  with a Murphy eye
7 Requirements for tracheal tubes with tracheal
  tube connectors supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (normative) - Determination of cuff
        diameter
Annex C (normative) - Test method for cuffed
        tube collapse
Annex D (normative) - Test method for cuff
        herniation
Annex E (informative) - Guidance on design of
        tracheal tube connectors
Annex F (informative) - Hazard identification
        for risk assessment
Annex G (normative) - Test method for tracheal
        seal
Annex H (normative) - Test method to determine
        kink resistance
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
Requirements of EU Directive 93/42/EEC

ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.

Committee
CEN/TC 215
DevelopmentNote
Supersedes EN 1782. (05/2013)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
Supersedes

EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

ISO 11990-1:2011 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft
ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ANSI Z79.16 : 1983 CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ASTM F 1242 : 1996 : EDT 1 Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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