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ISO 5361:2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Anaesthetic and respiratory equipment — Tracheal tubes and connectors
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

01-17-2023

Language(s)

English, French

Published date

08-26-2016

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.

DevelopmentNote
Supersedes ISO 5361-1, ISO 5361-2, ISO 5361-3 & ISO 5361-5 (04/2001) Supersedes ASTM F 1242 and ASTM F 1243 (01/2006) Supersedes ISO 5361-4. (12/2012) Supersedes ISO/DIS 5361. (08/2016)
DocumentType
Standard
Pages
41
PublisherName
International Organization for Standardization
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 11990-2:2016-02 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS (ISO 11990-2:2010)
05/30138123 DC : DRAFT AUG 2005 BS ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA Z168.5.6 : 1996 : R2006 EXPIRED-AIR PULMONARY RESUSCITATORS
DIN EN ISO 11990-1:2016-02 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 1: TRACHEAL TUBE SHAFT (ISO 11990-1:2011)
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DIN EN ISO 15883-2:2009-09 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
UNE-EN ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
EN ISO 5366:2016 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
BS EN ISO 8836:2014 Suction catheters for use in the respiratory tract
03/106945 DC : DRAFT APR 2003 BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
04/30109833 DC : 0 ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA ISO 11712 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
CSA Z168.5.6 : 1996 : INC : UPD 1 : 1996 : R2011 EXPIRED-AIR PULMONARY RESUSCITATORS
CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
ANSI/AAMI/ISO 16142-1:2016 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA ISO 11712:14 (R2019) Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
ISO 8836:2014 Suction catheters for use in the respiratory tract
DIN EN ISO 14408:2016-07 TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
ISO 11990-1:2011 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft
I.S. EN ISO 5366-1:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
I.S. EN ISO 15883-2:2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
DIN EN ISO 5366:2017-04 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016); German version EN ISO 5366:2016
I.S. EN ISO 14408:2016 TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
I.S. EN 1282-2:2005 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
DIN EN ISO 5366-1:2009-07 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
DIN EN ISO 5366:2015-10 (Draft) ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)
BS EN ISO 11990-2:2014 Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes Tracheal tube cuffs
17/30327513 DC : DRAFT APR 2017 BS EN ISO 11990 - LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBE SHAFT AND TRACHEAL CUFFS
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
I.S. CEN ISO TS 15883-5:2006 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
I.S. EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
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 ISO 15883-2:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
UNE-EN 1282-2:2006 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
ONORM EN 13718-2 : 2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
UNI EN ISO 5366-1 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN ISO 15883-2 : 2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
UNI EN 1282-2 : 2009 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
CSA Z15883-5:09 (R2019) Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (Adopted ISO/TS 15883-5:2005, first edition, 2005-11-15)
DIN EN ISO 5366 E : 2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)
UNE-EN ISO 11990-1:2012 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
BS EN ISO 5366:2016 Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
ISO 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
I.S. EN ISO 11990-2:2014 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS (ISO 11990-2:2010)
ISO 5366:2016 Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors
ANSI/AAMI ST15883-2:2013(R2015) (ISO 15883-2:2006 MOD) WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
BS EN ISO 14408:2016 Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
BS EN 1282-2 : 2005 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
BS EN ISO 5366-1:2004 Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes and connectors for use in adults
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 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
EN ISO 11990-1:2014 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
EN ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
EN ISO 11990-2:2014 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2011)
BS ISO 11712:2009 Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
CAN/CSA-Z168.5.6-96 (R2016) Expired-Air Pulmonary Resuscitators
ASTM F 2726 : 2008 Standard specification for fixation devices for tracheal tubes and other airway devices
CSA Z15883-2 : 2009 : R2014 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
AAMI ST15883-2 : 2013 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
BS EN ISO 11990-1:2014 Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes Tracheal tube shaft
I.S. EN ISO 11990-1:2014 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 1: TRACHEAL TUBE SHAFT (ISO 11990-1:2011)
CSA Z15883-2 : 2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
UNE-EN ISO 5366:2017 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
CSA Z15883-5 : 2009 : R2014 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
ISO 27427:2013 Anaesthetic and respiratory equipment — Nebulizing systems and components
DIN EN 1282-2:2009-12 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES

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
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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