EN ISO 5361:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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)
30-09-2019
28-09-2016
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Withdrawn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 |
| Standards | Relationship |
| ONORM EN ISO 5361 : 2017 | Identical |
| DS EN ISO 5361 : 2016 | Identical |
| UNI EN ISO 5361:2016 | Identical |
| NBN EN ISO 5361 : 2016 | Identical |
| SS-EN ISO 5361:2016 | Identical |
| I.S. EN ISO 5361:2016 | Identical |
| UNI EN ISO 5361 : 2013 | Identical |
| BS EN ISO 5361:2016 | Identical |
| DIN EN ISO 5361:2014-05 (Draft) | Identical |
| SN EN ISO 5361 : 2016 | Identical |
| PN EN ISO 5361 : 2017 | Identical |
| NEN EN ISO 5361 : 2016 | Identical |
| NF EN ISO 5361 : 2016 | Identical |
| NS EN ISO 5361 : 2016 | Identical |
| ISO 5361:2016 | Identical |
| UNE-EN ISO 5361:2017 | Identical |
| DIN EN ISO 5361:2017-01 | Identical |
| 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 |
| 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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