ISO 7376:2020 麻酔および呼吸装置 — 気管挿管用の喉頭鏡 | 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, 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 third edition cancels and replaces the second edition (ISO 7376:2009), which has been technically revised.

The main changes compared to the previous edition are as follows:

• the layout has changed to align with ISO 18190:2016;
• removal of the requirements for filament luminaires, which are now almost entirely replaced by LED luminaires;
• additional requirement to prevent current surges from batteries with a rated voltage exceeding 3,6 V;
• test methods have been rationalized;
• each requirement is now followed by a conformance requirement;
• the strength requirement has been extended to handles;
• environmental conditions during transport, storage and normal use are now referenced to IEC 60601-1-12.

Introduction

Laryngoscopes are manufactured in several forms. There are, for example, single‐piece laryngoscopes, non‐user-detachable hingedlaryngoscope blades, or detachable hinged laryngoscope blades and handles. In the latter case, the light source for illuminating the larynx during use is either a luminaire fixed in the laryngoscope blade or a luminaire in the handle with a light guide in the laryngoscope blade. The minimum light output from the laryngoscope is specified.

Laryngoscope blades are defined and marked by size designation (see Table 2), suitable for the patient demographic for which they are designed and ranges from small, premature infants to extra-large adults. Because there are so many variations, the length of laryngoscope blade is disclosed on the packaging to allow an informed decision by the operator to select the most appropriate instrument for intubation. Annex B describes test methods for illumination, rigidity and strength.

Throughout this document the following print types are used:

• Requirements and definitions: roman type;
• Conformance tests: 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: 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.

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 terminological databases for use in standardization at the following addresses:

Bibliography