ISO 8836:2019 気道で使用するための吸引カテーテル | ページ 2

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

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 ).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.

This fifth edition cancels and replaces the fourth edition (ISO 8836:2014), which has been technically revised. The main changes compared to the previous edition are as follows:

—it is no longer a requirement to have only male-type suction catheter connector on the suction catheter;

—the female-type suction catheter connector has been reinstated following removal in the fourth edition of this document;

—the terms and definitions have been revised;

—the conditions for the measurement of residual vacuum in closed suction catheters have been revised.

Introduction

This document is concerned with the basic requirements and method of size designation of both open and closed suction catheters made of flexible materials.

The method of describing tube dimensions and configuration has been devised in order to assist clinicians in the selection of the most suitable suction catheter for a particular patient. The size designation is important when selecting a catheter because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube^[2][3].

Throughout this document the following print types are used:

• Requirements and definitions: roman type;
• Conformance checks and 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;
• defined terms: italics.

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.

1 Scope

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.

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 following terms and definitions apply.

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

Bibliography