ISO/FDIS 18665

Traditional Chinese medicine -- Herbal decoction apparatus

ISO 18665.2015 specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. It is applicable to the herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.

Médecine traditionnelle chinoise -- Appareil décoction herbe-médicinale

General Information

• Status: Published
• ICS: 11.040.99 - Other medical equipment
• ICS: 23.020.30 - Pressure vessels, gas cylinders
• ICS: 27.060.30 - Boilers and heat exchangers
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 5060 - Close of voting Proof returned by Secretariat
• Completion Date: 07-Dec-2021

RELATIONS

• Revised: ISO 18665:2015 - Traditional Chinese medicine -- Herbal decoction apparatus
• Effective Date: 26-Nov-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18665
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Herbal decoction apparatus
Voting begins on:
2021-10-12
Médecine traditionnelle chinoise — Appareil décoction herbe-
médicinale
Voting terminates on:
2021-12-07
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 18665:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 18665:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
© ISO 2021 – All rights reserved
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ISO/FDIS 18665:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Material ......................................................................................................................................................................................................... 2

4.2 Surface quality ........................................................................................................................................................................................ 2

4.3 Performance ............................................................................................................................................................................................. 2

4.4 Electrical safety ..................................................................................................................................................................................... 2

4.5 Machinery safety .................................................................................................................................................................................. 3

5 Test methods ............................................................................................................................................................................................................ 4

5.1 Material test .............................................................................................................................................................................................. 4

5.2 Surface quality test ............................................................................................................................................................................. 4

5.3 Performance test .................................................................................................................................................................................. 4

5.3.1 Hermetic container test ............................................................................................................................................... 4

5.3.2 Pipeline system and valve test ............................................................................................................................... 4

5.3.3 Pipeline diameter test.................................................................................................................................................... 4

5.3.4 Loading test ............................................................................................................................................................................ 4

5.3.5 Leakage test of lubricating system .................................................................................................................... 5

5.3.6 Decocting timing error test ...................................................................................................................................... 5

5.3.7 Working temperature test ......................................................................................................................................... 5

5.4 Electrical safety test .......................................................................................................................................................................... 5

5.5 Machinery safety test ....................................................................................................................................................................... 6

6 Inspection rules .................................................................................................................................................................................................... 6

6.1 Delivery inspection ............................................................................................................................................................................ 6

6.2 Pattern inspection ............................................................................................................................................................................... 6

6.2.1 Pattern inspection conditions ................................................................................................................................ 6

6.2.2 Pattern inspection items ............................................................................................................................................. 6

6.2.3 Sampling .................................................................................................................................................................................... 7

6.2.4 C onformity test .................................................................................................................................................................... 7

7 Labels, instructions for use and storage .................................................................................................................................... 7

7.1 Labels .............................................................................................................................................................................................................. 7

7.2 Instructions for use ............................................................................................................................................................................ 7

7.3 Storage ........................................................................................................................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

iii
© ISO 2021 – All rights reserved
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ISO/FDIS 18665:2021(E)
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 18665:2015), of which it constitutes a

minor revision. The changes are as follows:
— General: 'this International Standard' changed to 'this document';

— Clause 3: addition of the introductory text according to ISO/IEC Directives, Part 2;

— 3.2: “hemetic” changed to “airtight” in definition;
— 3.3: “non-hemetic” changed to “non-airtight” in definition;
— 4.3.4: “dependable without leakage” changed to “watertight”;
— 4.5.1: “give” changed to “generate”;
— 4.5.5: “put on” changed to “attached to”;
— minor editorial changes.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2021 – All rights reserved
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ISO/FDIS 18665:2021(E)
Introduction

This document has been developed in response to worldwide demand for herbal decoction apparatus

traded internationally. There is a wide variety of herbal decoction apparatus currently available

commercially, but there are no standards guiding its manufacture. Increased use of decoctions as a

means of administering herbal medicine, as well as growing patient expectations and concerns

regarding safety and quality, have given rise to the need to improve the safety and quality of herbal

decoction apparatus through implementation of an International Standard.

There are two main types of herbal decoction apparatus in common use. According to the structure

of herbal decoction apparatus, it can be divided into hermetic decoction apparatus and non-hermetic

decoction apparatus

The primary aim of this document is to ensure the safety and quality of both non-hermetic decoction

apparatus and hermetic decoction apparatus.
© ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 18665:2021(E)
Traditional Chinese medicine — Herbal decoction
apparatus
1 Scope

This document specifies the general requirements of herbal decoction apparatus with design pressures

less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus.

This document is applicable to herbal decoction apparatus for individual herbal formula prescriptions

and for commercial use as well as private use. It also applies to the decocting part of the integrated

apparatus of decoction and package.
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.

ISO/IEC Guide 37:2012, Instructions for use of products by consumers

ISO 780, Packaging — Distribution packaging — Graphical symbols for handling and storage of packages

ISO 16528-1:2007, Boile
...