ISO/TC 121/SC 2 - Airways and related equipment

This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).

This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings. It is not applicable to the following: — flexible laryngoscopes; — laryngoscopes designed for surgery; — laryngoscopes powered from mains electricity supply; — laryngoscopes connected by light‐transmitting cables to external light sources; — video laryngoscopes designed to work with an external, integral or attached video system.

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

ISO 18190:2016 specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it. The requirements of a device-specific standard take priority over ISO 18190:2016. NOTE General requirements contained in ISO 18190:2016 have historically been referenced in more than two other airways and related equipment standards.

ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support. ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases. Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard. NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

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.

ISO 14408:2016 specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser

ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions. ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled. Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

ISO 27427:2013 specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. ISO 27427:2013 includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

ISO 11712:2009 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. ISO 11712:2009 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. ISO 11712:2009 requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible.

ISO 16628:2008 provides requirements for size designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of ISO 16628:2008.

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life. ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

ISO 23328-1:2003 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired gases. ISO 23328-1:2003 is applicable to BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. Non-filtration aspects of BSF are addressed in ISO 23328-2.

ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. A method for assessing filtration performance of BSF is given in ISO 23328-1.

ISO 8836:2014 specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract. Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of ISO 8836:2014.

ISO 27427:2010 specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an aerosol form, to humans through the respiratory system. ISO 27427:2010 includes gas-powered nebulizers which can be powered by, for example, compressors, pipeline systems, cylinders, etc., and electrically-powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive) and capillary devices] or manually-powered nebulizers. ISO 27427:2010 does not apply to devices intended for nasal deposition. ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form. ISO 27427:2010 does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).

ISO 7376:2009 gives general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the interchangeability of blades and handles. It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx, since electrical safety requirements can be more stringent for instruments connected to mains or external power packs. It is not applicable to surgical instruments known by the same generic name, nor is it applicable to flexible laryngoscopes or laryngoscopes designed for surgery, laryngoscopes powered from mains electricity supply, laryngoscopes connected by light-transmitting cables to external light sources, or video laryngoscopes designed to work with an external video system.

ISO 27427:2009 specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an aerosol form, to humans through the respiratory system. ISO 27427:2009 includes gas-powered nebulizers which can be derived from, e.g., compressors, pipeline systems, cylinders etc., and electrically-powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive) and capillary devices] or manually-powered nebulizers.

ISO 5364:2008 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.

ISO 8836:2007 specifies requirements for suction catheters made of plastic materials and intended for use in suction of the respiratory tract. Specialized suction catheters, e.g. those with more than one lumen and suction catheters without a terminal orifice, are excluded from the scope of this International Standard. Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of ISO 8836:2007.

ISO 14408:2005 specifies marking, labelling and information supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.

ISO 7376:2003 specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes. It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical safety requirements may be more stringent for instruments connected to mains or external power packs. ISO 7376:2003 is not applicable to surgical instruments known by the same generic name. ISO 7376:2003 does not apply to: -- the blade form or handle design, except for general requirements and the interchangeability aspects of the connection between the blade and the handle; -- the measurement and specification of the lamp illumination intensity; -- flexible laryngoscopes, or laryngoscopes designed for surgery; -- laryngoscopes powered from mains electricity supply; -- laryngoscopes connected by light-transmitting cables to external light sources. Instruments connected by light guides to an external light source may be subject to other International Standards for endoscopes.

ISO/TS 16628:2003 provides recommendations for the size designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of this Technical Specification.

Gives basic dimensions and performance requirements for two designs of re-usable rigid laryngoscopes, in which light from a source in the handle is transmitted to the blade by means of illuminating fibres.

Intended to help minimize the risk of an airway fire when using a laser. Represents current knowledge at the time of publication and is subject to review. Does not address management of the patient with a tracheotomy. Also intended to assist related groups, such as laser safety committees.

Cancels and replaces the first edition (1984). Lays down critical dimensions and considerations for the junction of any blade and any handle of a hook-on type laryngoscope to allow engagement, lamp illumination and disengagement through multiple cycles. Does not cover: the blade form or handle design other than the interchangeability aspects of the connection between the blade and the handle; the measurement and specification of the lamp illumination intensity; disposable or flexible laryngoscopes, or laryngoscopes designed for surgery; laryngoscopes without a lamp in the blade.

Specifies requirements (size, materials, connectors, adaptor, inner tube, neck-plate, cuff, introducer (obturator), unit container, marking) for cuffed and plain paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2 mm to 6 mm.

Corrects an ambiguity in ISO 5364-1986.