ISO 5366:2016 pdf free
ISO 5366:2016 pdf free.Anaesthetic and respiratory equipment一Tracheostomy tubes and connectors
ISO 5366 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 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment一Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment一Conical connectors一Part 1: Cones and sockets
ISO 18190:2016, Anaesthetic and respiratory equipment一General requirements for airways and related equipment
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications一Part 7: Connectors for intravascular or hypodermic applications
ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2503, Standard Practice for Marking Medical Devices and Other ltems for Safety in the Magnetic Resonance Environment
The manufacturer may use type tests different from those detailed within this International Standard if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test methods specified in ISO 5366.
Check compliance by inspection of the manufacturer’s technical file.ISO 5366 pdf download.
