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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Anaesthetic and respiratory equipment — Tracheal tubes and connectors
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
17-01-2023
Superseded by
Language(s)
English, French
Published date
26-08-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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)
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| DocumentType |
Standard
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| Pages |
41
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| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 5361 : 2017 | Identical |
| DS EN ISO 5361 : 2016 | Identical |
| NF EN ISO 5361 : 2016 | Identical |
| NBN EN ISO 5361 : 2016 | Identical |
| NEN EN ISO 5361 : 2016 | Identical |
| NS EN ISO 5361 : 2016 | Identical |
| I.S. EN ISO 5361:2016 | Identical |
| PN EN ISO 5361 : 2017 | Identical |
| SN EN ISO 5361 : 2016 | Identical |
| UNI EN ISO 5361 : 2013 | Identical |
| SS-EN ISO 5361:2016 | Identical |
| UNE-EN ISO 5361:2017 | Identical |
| BS EN ISO 5361:2016 | Identical |
| EN ISO 5361:2016 | Identical |
| DIN EN ISO 5361:2014-05 (Draft) | Identical |
| NBR ISO 5361 : 2017 | Identical |
| CSA ISO 5361 : 2014 | Identical |
| AAMI ISO 5361 : 2012 | Identical |
| NEN ISO 5361 : 1999 | Identical |
| DIN EN ISO 5361:2017-01 | Identical |
| BIS IS/ISO 5361 : 1999(R2017) | Identical |
| CSA Z5361 : 2003 | Identical |
| 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 |
| 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) |
| 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 |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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