ISO 18665:2015

INTERNATIONAL ISO
STANDARD 18665
First edition
2015-11-01
Traditional Chinese medicine —
Herbal decoction apparatus
Médecine traditionnelle chinoise — Appareil décoction herbe-
médicinale
Reference number
ISO 18665:2015(E)
©
ISO 2015

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ISO 18665:2015(E)

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© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

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ISO 18665:2015(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. 6
6.2.4 Conformity 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
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ISO 18665:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.
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ISO 18665:2015(E)

Introduction
This International Standard 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 their manufacture. Increased use of
decoctions as a means of administering herbal medicine, as well as growing patients’ 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 International Standard is to ensure the safety and quality of both non-hermetic
decoction apparatus and hermetic decoction apparatus.
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INTERNATIONAL STANDARD ISO 18665:2015(E)
Traditional Chinese medicine — Herbal decoction apparatus
1 Scope
This International Standard 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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, Boilers and pressure vessels — Part 1: Performance requirements
ISO 16528-2:2007, Boilers and pressure vessels — Part 2: Procedures for fulfilling the requirements of
ISO 16528-1
ISO 21469:2006, Safety of machinery — Lubricants with incidental product contact — Hygiene requirements
IEC 60204-1:2009, Safety of machinery — Electrical equipment of machines — Part1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
herbal decoction apparatus
device that produces the herbal liquid by extracting medicinal herb pieces with water and heat
3.2
hermet
...