ISO 5366:2016 download free.Anaesthetic and respiratory equipment – Tracheostomy tubes and connectors.
ISO 5366 provides the essential requirements for the design of cuffed and uncuffed TRACHEOSTOMY TUBES and connectors. These devices are intended to be inserted through a stoma in the trachea to convey gases and vapours to and from the trachea. Cuffed devices are designed to seal and protect the trachea from aspiration and to provide an unobstructed airway In patients during spontaneous, assisted or controlled ventilation for short or prolonged durations. Specialized tubes with walls reinforced with metal or nylon, tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery old rugs or other gases and the many other types OITRACHEOSTOMY tUBES devised for specialized applications are included In this specification, as many specialized ‘FRACHEOS’roMyTuBEs are now commonly used, and all share similar essential requirements defined in ISO 5366.
The method of describing tube dimensions and configuration has been devised in order to assist clinicians In the selection of the most suitable tube for a particular patient’s anatomy. Size Is designated by the Internal dimension, which is important because of its relationship to resistance to gas flow. Because stoma and tracheal sizes are also Important factors when selecting a TRACHEOSTOMY TUBE, it Is considered essential that the outside dimension for each size of tube is also made known to the user.
Cuffed ‘rRAcuEoS’rouv TUBES can be characterized by a combination of the tube inside and outside dimensions and by the diameter of the CUFF.
A variety of curr designs are available to meet particular clinical requirements.ISO 5366 encompasses requirements for both paedlarric and adult TRACHEOSTOMY TUBES. They share many common requirements that can be standardized and which are important for patient safety. An infant or child differs from an adult, not only In size, but also with regard to airway anatomy and respiratory physiology; thus, airway equipment for paedlatrlc patients differs from that for adults. both In size and in basic design. This lnternatlona) Standard does not require the connector to be permanently attached to the tube, as this can be impractical with infants and small children. Other acceptable methods of connecting these components are available, and this ISO 5366 makes provision for them. ISO 5366 does not limit the range of tube designs needed to match the variations in paediatric anatomy, lesions and space limitatons encountered.
Kink resistance requirements with associated test methods have also been added to ISO 5366  to measure the ability of the shaft of the TRACHEOSTOMY TUBE to resist collapse and increased breathing resistance when bent or curved.
Requirements for TRACHEOSTOMY TUBES that are common to other airway and related devices have been removed from ISO 5366 as these are now included in ISO 18190, which is cross referenced where appropriate.
Throughout ISO 5366, the following print types are used:
— requirements and definitions: roman type;
— test specifications: itahc type-.
— informative material appearing outside of tables, such as notes, examples and references smaller
type. The Normative text of tables is also in smaller type;
— TERMS DEFINED IN CLAUSE 3: S4ALL. CAPS.
An asterisk 0 as the first character of a title or at the beginning of a paragraph or table title Indicates that there Is guidance or rationale related to that item In Annex A.
1 Scope
ISO 5366 specifies requirements for adult and paediatric RACHKOS1’OUV 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 TRAI4EOSTOMY 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/FR 11991 gives guidance on avoidance of sirway fires.
2 Normative references
The following documents, in whole or In part, are normatively referenced in this document and are Indispensable ror 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 — Vocabulary
ISO 5356-1, AnaesthetIc and respfratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 18190:2016. AnaesthetIc and respfratory equipment — General requirements for airways and related equipment
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ASTM F2052, Standard Test Method for Measurement q Magnetically Induced Displacement Force an Medical Devices in the Magnetic Resonance Environment
ASTM F2503, Standard Practice for Marking Medico? Devices and Other Items for Safety in the Magnetic Resonance Environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in 150 4135 and the following apply.
NOTE See Egurei for illustrations of typical TRACHF.OSTOMY TUBES and associated nomenclature.
ANGLE OF BEVEL
angle between the plane of the BEVEl. (3.2) and the longitudinal axis of a TRACHEOSTOMY TUBE (113)
3.2
BEVEL
slanted portion at the PATIENT END (112) of a TRACHEOSTOMY TuRF. (113)
8.3.2 Cuffed tubes shall be marked with the diameter of the cun expressed in millimetres to two sign ilicant figures In accordance with 6.3.4A, where practicable.
Check compliance by wsual inspection and the tests given in A,we.xL
8.4 Marking of TRACHOSTOMY TUBE connectors
The TRACHEOSTOMY TUBE connector, II not fitted to the TRACHEOSTOMY TUBE, shall be marked with Its minimum inside diameter, expressed In millimetres (see 6.LLZ).
Check compliance by visual Inspection.
8.5 Additional labelling of unit packs
In addition to the general labelling requirements of ISO 18190, individual packs or a package insert shall be clearly labelled to indicate the following:
a) the designated size in accordance with 62J,
b) the outside dimension, expressed In millimetres in accordance with 6L2
C) the NOMINAL LENGTH, (or the range of lengths for TRACHEOSTOMY TUBES with an adjustable NECK’ PLATE), expressed in millimetres in accordance with 62J
d) if a connector is not provided, a statement to this effect;
e) a figure with the dimensions, in millimetres, indicated in Figure Las a, b.c. d and e, if applicable. For tubes with an adjustable NECK-PLATE, the maximum dimension, b [see Figures 2 a) or b)j.
I) angle B (see Figure 2) measured in degrees;
g) for cuffed tubes, the diameter of the CUFF, determined in accordance with AnnexC. and expressed in millimetres to two significant figures;
Ii) If an INNER TUBE Is provided in the TRACHEOSTOMY TUBE unit pack, the nominal Inside dimension of the INNER TUBE, expressed in millimetres.
Check compliance by visual Inspection and the relevun: requirements In ISO 18190.
8.6 Labelling of INNER TUBE unit packs
In addition to the general labelling requirements of ISO 18190, INNER TUBE unit packs shall be clearly labelled to indkate the following:
a) the designated size of the OUTER TuBE into which it is designed to lit:
b) the nominal Inside dimension of the INNER TUBE, expressed in millImetres. Check compliance by visual inspection and the relevant requirements In ISO 18190.
8.7 Labelling of TRACHEOSTOMY TUBE Inserts
In addition to the general labelling requirements of ISO 18190, the following shall be marked on the
TRACHEOSTOMY TUBE insert:
a) instructions for preparation of the TRACHEOSTOMY TUBE prior to use- If the instructions for preparation recommend the use of an additive substance, the type and amount of any applied substance;