ISO 18666:2021 伝統的な漢方薬—灸装置の一般的な要件 | 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 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 249, Traditional Chinese medicine.

This second edition cancels and replaces the first edition (ISO 18666:2015), of which it constitutes a minor revision. The changes to the previous edition are as follows:

• Introduction: the term 'International Standard' changed to 'document' in the first and third paragraphs; improvement of English expression to 'increasing expectations and concerns by patients' and the term 'ensure' changed to 'guide' in the second and third paragraphs;
• Scope: the term 'International Standard' changed to 'document' in the first and third paragraphs; minor editorial change of the term 'uses' to 'use' in the second paragraph;
• Clause 3: addition of the introductory text according to ISO/IEC Directives, Part 2;
• 3.4: deletion of the phrase 'during treatment';

—4.1.1: improvement of English expression for clarity;

—minor editorial changes.

Introduction

This document specifies the general requirements for safety and quality of moxibustion devices, including the moxibustion materials used in such devices. The safety and quality of both moxibustion devices and materials are closely related to moxibustion safety and quality.

There is a wide variety of moxibustion devices and materials currently available commercially, but there are no standards guiding their manufacture and finishing. Increased interest and use of moxibustion, as well as increasing expectations and concerns by patients regarding moxibustion safety and quality, have given rise to the need to improve safety and quality of moxibustion through implementation of an International Standard.

The primary aim of this document is to guide the safety and quality of moxibustion devices and materials.

Annex A gives guidance on the methods that can be used to determine the moxibustion temperature at the human body surface during treatment using the moxibustion device.

Annex B gives guidance on the method of artificial drying of mugwort leaves by heat.

1 Scope

This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices.

It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage.

This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

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