UNE-EN ISO 5361:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO 5361:2016)
Hardcopy , PDF
Spanish, Castilian, English
26-04-2017
20-09-2023
This International Standard 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 or 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.Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard.Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.NOTEISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this[1][2][3][4].
| Committee |
CTN 110
|
| DevelopmentNote |
Supersedes UNE EN 1782. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
62
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 5361:2016 | Identical |
| ISO 5361:2016 | Identical |
| 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 |
| 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 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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