ISO 14408:2016 レーザー手術用に設計された気管チューブ — マーキングおよび付随情報の要件 | 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, Part 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, Part 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 on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

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

This third edition cancels and replaces the second edition (ISO 14408:2005), which has been technically revised.

Major changes include an update on the normative references to ISO 11990-1, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 1 Tracheal tube shaft and ISO 11990-2, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 2: Tracheal tube cuffs.

The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended, or revised ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.

Introduction

This International Standard is intended to provide requirements for marking, labelling, and information supplied for tracheal tubes which are designed for resistance to ignition by a laser and which have been tested for laser resistance in accordance with ISO 11990-1 and ISO 11990-2 including a standard format for reporting results obtained when tested in accordance with ISO 11990-1 and ISO 11990-2. It is intended that, by limiting the requirements to disclosure of information determined in accordance with standard test methods, the manufacturer will be allowed maximum use of alternatives in design and materials.

1 Scope

This International Standard specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser

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 following terms and definitions apply.

Bibliography