BS ISO 11712:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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. Supralaryngeal airways and connectors
Hardcopy , PDF
10-11-2023
English
31-05-2009
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/121/5
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| DocumentType |
Standard
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| Pages |
40
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| PublisherName |
British Standards Institution
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| Status |
Superseded
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| SupersededBy |
1.1 This International Standard provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation.
1.2 This International Standard specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this International Standard.
1.3 The following devices are outside the scope of this International Standard: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement.
1.4 This International Standard requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible.
1.5 Flammability of airways, for example if used with certain flammable anesthetics, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this International Standard. See E.1.7.
| Standards | Relationship |
| ISO 11712:2009 | Identical |
| 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 |
| ASTM F 2560 : 2006 | Standard Specification for Supralaryngeal Airways and Connectors |
| ISO 5364:2016 | Anaesthetic and respiratory equipment — Oropharyngeal airways |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| 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 |
| ISO/TS 16628:2003 | Tracheobronchial tubes Recommendations for size designation and labelling |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11990:2003 | Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| 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 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO/TS 15843:2000 | Sterilization of health care products Radiation sterilization Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| AAMI TIR20 : 2001 | PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |
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