ISO 22217:2020
(Main)Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.
Médecine traditionnelle chinoise — Exigences de conservation pour les matières premières et les décoctions
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 22217
First edition
2020-07
Traditional Chinese medicine —
Storage requirements for raw
materials and decoction pieces
Médecine traditionnelle chinoise — Exigences de conservation pour
les matières premières et les décoctions
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
4.1 Storage areas. 2
4.2 Package materials and containers . 2
5 Optimum storage conditions . 2
5.1 General . 2
5.2 Storage requirements of raw materials and decoction pieces . 3
5.2.1 Normal temperature and dry place . 3
5.2.2 Cool and dry place .20
5.2.3 Normal temperature and moist place .26
5.2.4 Cool and moist place .26
5.3 Specified storage requirements of raw materials and decoction pieces .27
5.3.1 In a well-closed container .27
5.3.2 In a tighted container .28
5.3.3 Protection from light .28
Annex A (informative) Reference values of national and regional limits of temperature and
relative humidity for storage .30
Annex B (informative) Storage attention for raw materials and decoction pieces .31
Annex C (informative) Collaborative storage .46
Annex D (informative) Close monitoring raw materials and decoction pieces .47
Bibliography .50
Foreword
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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
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv © ISO 2020 – All rights reserved
Introduction
Raw materials (Chinese materia medica) and decoction pieces have originated from various and
complex sources, such as plants, animals and minerals. Also, different raw materials and decoction
pieces contain different compositions. Without the proper storage conditions (regarding temperature,
humidity, air and sunlight), quality variation could easily occur. There are many possible variations
in the quality of raw materials and decoction pieces, including damage by worms or vermin, mould,
oil extravasation, dicolouring, loss of odour, efflorescence, deliquescence, adhesion, volatilization and
decay. In other words, inappropriate storage conditions and methods could lead to quality variation
and economic loss, as well as variation in the efficacy and safety of raw materials and decoction pieces
in clinical medication use.
Storage requirements for raw materials and decoction pieces give scientific, reasonable, economic
and effective storage conditions for different raw materials and decoction pieces. In these conditions,
raw materials and decoction pieces can be effectively protected from quality variation and the safety,
quality and clinical effectiveness of raw materials and decoction pieces can thus be guaranteed.
This document gives information that can remind the user to give priority to the unstable or expensive
raw materials and decoction pieces; to avoid predictable quality variation; and to reduce losses. For
example, raw materials and decoction pieces rich in grease, starch and protein could be damaged by
worms; raw materials and decoction pieces rich in grease, volatile oil and mucilage could have oil
extravasation at high temperatures and relative humidity; or raw materials and decoction pieces rich
in volatile oil could lose their odour.
As national implementation may differ, national standards bodies are invited to modify the values given
in 5.2.1, 5.2.2, 5.2.3 and 5.2.4 in their national standards. Examples of national and regional values are
given in Annex A.
Examples of storage attention for raw materials and decoction pieces to avoid quality variations are
given in Annex B. Information of a traditional Chinese medicine storage method named "Collaborative
storage" is given in Annex C. Examples of toxic and rare raw materials and decoction pieces needing
close monitoring are given in Annex D.
INTERNATIONAL STANDARD ISO 22217:2020(E)
Traditional Chinese medicine — Storage requirements for
raw materials and decoction pieces
1 Scope
This document specifies the general storage requirements for raw materials and decoction pieces.
It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.
2 Normative references
There are no normative references in this document.
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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
storage
preservation measures for keeping raw materials and decoction pieces under defined conditions,
retaining effective ingredients and biological activity of raw materials and decoction pieces, preventing
spoilage, quality variation and contamination, and ensuring quality and safety of raw materials and
decoction pieces
3.2
raw materials
Chinese materia medica
CMM
medicinal parts of medicinal plants, animals and minerals after preliminary processing, which are used
as crude materials to make decoction pieces in Chinese medicine
[SOURCE: ISO 18662-1:2017, 3.1, modified — Note 1 to entry removed.]
3.3
decoction piece
prescription medicinal processed from Chinese materia medica under the guidance of TCM theory and
processing methods for Chinese medicines
Note 1 to entry: Decoction pieces are directly used in clinical practice or the production of prepared medicines.
[SOURCE: ISO 18668-1:2016, 3.3]
3.4
protected from light
kept in a container that can prevent transmittance of light affecting the specified properties and quality
of the contents under ordinary conditions of handling, shipment and storage
3.5
well-closed container
container with a closure system that protects the contents from extraneous solids and from loss of the
contents under ordinary conditions of storage
3.6
tightened container
container with a closure system that protects the contents from extraneous solids or liquids, from loss of
the contents, and from efflorescence, deliquescence or evaporation under ordinary conditions of storage
3.7
cool place
storage location where a substance is kept at an ambient temperature not exceeding 20 °C
3.8
normal temperature place
storage location where a substance is kept at an ambient temperature of 20 °C to 30 °C
3.9
dry place
storage location where a substance is kept at a relative humidity not exceeding 60 %
3.10
moist place
storage location where a substance is kept at a relative humidity of 60 % to 100 %
3.11
collaborative storage
storage method that keeps two or more kinds of raw materials and decoction pieces together,
preventing quality variation like damage by worms or vermin, discolouring or mould of raw materials
and decoction pieces
4 General
4.1 Storage areas
Storage areas shall be clean and free from rats, pests, flies, birds or any other animals. Contamination
and cross-contamination of raw materials and decoction pieces shall be avoided.
4.2 Package materials and containers
Immediate package materials and containers shall be innocuous and clean, shall not interact with the
raw materials and decoction pieces packed, and shall not affect the quality of the raw materials and
decoction pieces in the containers.
The external package shall label the product name and plant scientific name, quality features, country
and province/state, date of production and expiry date, and storage method and requirements of the
raw materials and decoction pieces.
5 Optimum storage conditions
5.1 General
Storage requirements specify the temperature and relative humidity (RH) of storage location. Specified
storage requirements specify certain raw materials and decoction pieces that should be protected from
air or light, be non-powdered, be uncomminuted or be under nitrogen.
2 © ISO 2020 – All rights reserved
Unless otherwise specified, if the decoction piece has the same name as the corresponding raw
materials, it shares the same storage requirements of the corresponding
...
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