ISO 22610:2018 患者、臨床スタッフ、および機器用の医療機器として使用される外科用ドレープ、ガウン、およびクリーンエアスーツ—湿った細菌の侵入に対する耐性を決定するための試験方法 | 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.

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 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 the following URL: www.iso.org/iso/foreword.html .

This document was prepared by ISO/TC 94, Personal safety — Protective clothing and equipment, SC 13, Protective clothing.

This second edition cancels and replaces the first edition (ISO 22610:2006), which has been technically and editorially revised.

Although the same principle applies as for ISO 22610:2006, this revised test method should be considered technically as a new test method.

The main differences between this document and ISO 22610:2006 are:

• Different strain of bacterial species;
• More detailed description of equipment, reagents and materials;
• Tighter tolerances on equipment requirements;
• Tighter tolerances on specimen (pre)treatment, preparation of the agar plates, bacterial inoculum and donor;
• Strict protocol for the test procedure.

Introduction

There are numerous examples of situations where bacteria carried by a liquid may migrate through a barrier material in the wet state. The wet penetration of skin flora through a covering material is one example (see Annex E).

European medical device regulations specifically place the responsibility for avoiding device-related infections on the manufacturer. In order to demonstrate compliance with this requirement and to describe a product to the user, there is a need to use harmonized and recognized international test methods.

The test method described in this international standard uses microbiological techniques and is therefore intended to be performed exclusively by laboratories experienced in and equipped for such work.

ISO 22610:2006 has been significantly revised in order to improve the precision of the test method.

The primary difference between this document and ISO 22610:2006 is that this document specifies a strain of a different bacterial species and tighter tolerances on material handling and procedure, resulting in more reproducible and accurate measurements.

In order to obtain accurate repeatable and reproducible results, not only does the equipment need to meet the requirements specified in this document, but also the material handling and test procedure need to be followed precisely and consistently. Minor deviations from the equipment requirements, procedure and/or specimen handling can result in considerable loss of repeatability, reproducibility and accuracy of the measurement.

1 Scope

This document specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

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