ISO 16628:2022 麻酔および呼吸装置—気管気管支 | ページ 2

Foreword

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The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, 2 (see www.iso.org/directives ).

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This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 16628:2008), which has been technically revised.

The main changes are as follows:

• alignment with the general standard for airway devices, ISO 18190;
• inclusion of requirements in addition to marking and sizing;
• updating of references.

Introduction

Tracheobronchial tubes are double lumen tracheal tubes that enable isolation of the airways of one lung from the other. This allows protection of one lung if there is bleeding or a leak in the airways of the other. They facilitate selective ventilation of each lung. One lumen ends in the trachea, with a tracheal cuff above the opening. The other lumen is designed to lie either in the right or the left main bronchus with a cuff sealing that bronchus. The cuff of a right-sided tube is usually shaped to permit ventilation of the right upper lobe.

The first edition of ISO 16628 only specified requirements for the marking and sizing of tracheobronchial tubes.

Throughout this document the following print types are used:

• requirements and definitions: roman 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: italics.

1 Scope

This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required.

Tracheal tubes that include bronchus blockers are excluded from the scope of this document

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. 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, ISO 18190 and the following apply:

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography