ISO 23328-1:2003 麻酔および呼吸用の呼吸システムフィルター — Part 1: ろ過性能を評価するための塩分試験法 | 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 2.

The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 23328-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment.

ISO 23328 consists of the following parts, under the general title Breathing system filters for anaesthetic and respiratory use:

• Part 1: Salt test method to assess filtration performance
• Part 2: Non-filtration aspects

Introduction

This part of ISO 23328 gives a method of test for assessing the filtration performance of breathing system filters (BSF).

BSF are used to reduce the number of particulates, including microorganisms, in gases delivered to, and exhaled from, patients.

BSF are exposed to various levels of humidity during clinical use. Exposure of the BSF to humidified air to simulate clinical use forms part of this method (see Annex A), as it is possible that such exposure can influence the filtration performance of the BSF.

In the test, the BSF is challenged with sodium chloride particles of the most penetrating size range, i.e. 0,1 µm to 0,3 µm (see Annex C).

It is recognized that transmission of microorganisms across a filter can occur due to “channeling” and “grow-through”. There are at present no accepted methods to quantify these occurrences. This test method is for comparison purposes only, and has no proven clinical relevance. The results are specific to the test method and no risk factor should be derived from it.

1 Scope

This part of ISO 23328 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired gases.

This part of ISO 23328 is applicable to BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

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