ISO 5366:2016 麻酔および呼吸装置 — 気管切開チューブおよびコネクター | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.

This first edition of ISO 5366 cancels and replaces ISO 5366-1 and ISO 5366-3, which have been technically revised.

Introduction

This International Standard 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 of drugs or other gases and the many other types of tracheostomy tubes devised for specialized applications are included in this specification, as many specialized tracheostomy tubes are now commonly used, and all share similar essential requirements defined in this International Standard.

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 tracheostomy tubes can be characterized by a combination of the tube inside and outside dimensions and by the diameter of the cuff.

A variety of cuff designs are available to meet particular clinical requirements. This International Standard encompasses requirements for both paediatric 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 paediatric patients differs from that for adults, both in size and in basic design. This International 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 International Standard makes provision for them. This International Standard does not limit the range of tube designs needed to match the variations in paediatric anatomy, lesions and space limitations encountered.

Kink resistance requirements with associated test methods have also been added to this International Standard 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 this International Standard as these are now included in ISO 18190, which is cross referenced where appropriate.

Throughout this International Standard, the following print types are used:

• requirements and definitions: roman type;
• test specifications: italic 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 inclause 3:small caps.

An asterisk (*) 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.

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.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.

3.13

tracheostomy tube

tube designed for insertion into the trachea through a tracheostomy

Figure 1—Typical tracheostomy tube

a)	b)

Key

1	inflating tube	8	outer tube
2	neck-plate	9	inflation indicator
3	cuff	10	inflation valve or closure device
4	patient end	11	tip
5	inflation indicator/pilot balloon	12	bevel
6	breathing system connector	β	angle of bevel (see 6.3.7)
7	machine end	l1	clamping length (see 6.3.7.2)

Figure 2—Basic dimensional datum references of a tracheostomy tube

a)	b)

Key

Θ	angle formed between the long axes of the tracheostomy tube at the machine end and the patient end

NOTE Figure 2 a) nominal length = b + c + a; Figure 2 b) nominal length = c.

Bibliography