ISO 9360-1:2000 麻酔および呼吸装置 — 人間の呼吸ガスを加湿するための熱および水分交換器（HME） — Part 1: 最小呼気量250mlで使用するためのHME | 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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this part of ISO 9360 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 9360-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment.

This first edition of ISO 9360-1 cancels and replaces, in part, the first edition of ISO 9360 (ISO 9360:1992), which has been technically revised.

ISO 9360 consists of the following parts, under the general title Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans:

• Part 1: HMEs for use with minimum tidal volumes of 250 ml
• Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml

Annexes A and B of this part of ISO 9360 are for information only.

Introduction

The gases generally available for medical use lack sufficient moisture to be physiologically acceptable to the respiratory tract of patients. Heat and moisture exchangers are used to raise the water content and the temperature of the gas delivered to the respiratory tract. They are primarily intended for use independently or as part of a breathing system.

1 Scope

This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, and describes test methods for their evaluation.

2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 9360. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 9360 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.

3 Terms and definitions

For the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and the following apply.