ISO 18665:2022

INTERNATIONAL ISO
STANDARD 18665
Second edition
2022-02
Traditional Chinese medicine —
Herbal decoction apparatus
Médecine traditionnelle chinoise — Appareil décoction herbe-
médicinale
Reference number
© ISO 2022
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ii
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
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
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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).
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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 2: IEC 60204-1 updated to the 2016 edition;
— 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.
iv
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.
v
INTERNATIONAL STANDARD ISO 18665:2022(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, 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 —
...