ISO 18668-1:2016
(Main)Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding rules for Chinese medicines
Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding rules for Chinese medicines
ISO 18668-1:2016 specifies rules to encode Chinese medicines, including decoction pieces, Chinese Materia Medica (raw materials) and granule forms of individual medicinals for prescriptions (GFIMP), but not Chinese patent medicines (CPM). Relevant coding standards for Kampo medicine, Korean medicine and other traditional medicines will be separately formulated as needed by experts in these areas. ISO 18668-1:2016 is suitable for decoction pieces, Chinese Materia Medica (raw materials), and granule forms of individual medicinals for prescriptions (GFIMP) in the fields of clinical medication, scientific research and teaching, and statistics and management.
Médecine traditionnelle chinoise — Système de codage des médecines chinoises — Partie 1: Règles de codage des médecines chinoises
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18668-1
First edition
2016-04-01
Traditional Chinese medicine —
Coding system for Chinese
medicines —
Part 1:
Coding rules for Chinese medicines
Médecine traditionnelle chinoise — Système de codage des médecines
chinoises —
Partie 1: Règles de codage des médecines chinoises
Reference number
ISO 18668-1:2016(E)
©
ISO 2016
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ISO 18668-1:2016(E)
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ISO 18668-1:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Coding principles . 2
4.1 Uniqueness . 2
4.2 Scientific integrity . 2
4.3 Scalability . 2
4.4 Compatibility . 2
4.5 Stability . 2
5 Coding technology . 2
5.1 Technical basis . 2
5.1.1 Layer 1 . 2
5.1.2 Layer 2 . 3
5.1.3 Layer 3 . 3
5.1.4 Layer 4 . 3
5.1.5 Layer 5 . 3
5.1.6 Layer 6 . 3
5.1.7 Layer 7 . 4
5.1.8 Layer 8 . 4
5.1.9 Layer 9 . 4
5.1.10 Layer 10 . 4
5.2 Structure . 4
5.3 Detailed description . 5
Annex A (normative) Code table of layer 4 to layer 9 . 7
Annex B (normative) Calculation of check digit .17
Annex C (informative) Examples .18
Bibliography .22
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ISO 18668-1:2016(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
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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
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Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.
ISO 18668 consists of the following parts, under the general title Traditional Chinese medicine — Coding
system for Chinese medicines:
— Part 1: Coding rules for Chinese medicines
— Part 2: Codes for decoction pieces
— Part 3: Codes for Chinese materia medica
— Part 4: Codes for granule forms of individual medicinals for prescriptions
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ISO 18668-1:2016(E)
Introduction
As the pharmaceutical materials extracted from natural and botanical products have become
increasingly attractive, significant progress has been achieved in identifying new sources of natural
products for traditional and alternative medicine. In particular, Chinese traditional medicine has been
the focus of tremendous research, development and applications worldwide. Accordingly, Chinese
medicinal materials are increasingly being used in countries around the world. Currently, there are
more than 70 countries that have established administrative systems to regulate Chinese Medicine. At
present, the annual sale of Chinese medicines has reached more than USD 16 billion and is increasing
at a rate of 10 % to 20 % per year with great future potential. At the same time, concerns of harm to
the body associated with the long-term use of synthetic drugs have been recognized. Therefore, many
countries are developing vigorous controls and regulations on using antibiotics and other synthetic
drugs, while recognizing the importance of traditional and alternative medicines. Thus, this brings
more opportunities for the development of the market of Chinese medicines.
Today, bar codes are widely used for managing almost all ordinary products that are put up for sale, for
example, an eraser or a pencil has its individually identifiable bar code. Yet so far, a bar coding system
for products used in Chinese medicine has not been given sufficient attention, making it difficult to
categorize the individual items for international trade and research development. This brings challenges
and concerns in government supervision and proper use by patients. As products for medicinal use,
Chinese medicines could have bar codes that can be integrated into the current bar code system that
is used for other commercial products. In this way, bar codes can be used to track sources and monitor
the quality of the products. Therefore, there is an urgent need to develop a bar code system for Chinese
medicine products that will enable to identify each specific Chinese medicine product.
The Coding System of Chinese Medicines is developed based on science and research rooted in plant
taxonomy, Chinese medicine, Chinese medicinal processing, and other established regulatory handbooks
and guidelines of GS1 General standard, central product classification (CPC) and ISO/IEC 15420, etc.
The codes help to translate complicated names of a wide variety of decoction pieces, Chinese Materia
Medica (raw materials), and granule forms of individual medicinals for prescriptions into transparent
digits. In this way, each Chinese medicine corresponds to a unique code as its identification.
The Coding System of Chinese Medicines aims to promote standardization and digitalization for
Chinese medicine, to ensure authenticity, equality, fairness and transparency in international markets
and trade and to facilitate government supervision and regulation of Chinese medicine. It is hoped that
it will help pharmaceutical enterprises to manage workflow and increase economic returns. It will
help healthcare delivery organizations, such as hospitals and dispensaries, to improve information
management systems that can ensure the accuracy of dispensing, ensuring the safe and effective use of
prescribed medicine.
As it has been previously acknowledged, Chinese decoction pieces are processed products of Chinese
Materia Medica, which are also known as raw materials. Thus when designing the coding system for
Chinese medicines, it is feasible that one set of rules could incorporate all the features of each category
of Chinese medicines, as they share the same medicinal source and medical part. To be specific, their
divergence and commodity attributes can be clearly described in one of the layers (layer 8) in this set
of coding rules. Granule forms of individual medicinals for prescriptions are innovative products made
from decoction pieces. Based on the same considerations of feasibility and cost-control, the granular
forms can be included within the same set of rules for decoction pieces.
However, although Chinese patent medicines (CPM) are made from decoction pieces, their coding rules
are more complicated and differ from decoction pieces. Therefore, this coding system is not fit for CPM,
and coding rules for CPM need to be formulated separately.
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INTERNATIONAL STANDARD ISO 18668-1:2016(E)
Traditional Chinese medicine — Coding system for Chinese
medicines —
Part 1:
Coding rules for Chinese medicines
1 Scope
This part of ISO 18668-1 specifies rules to encode Chinese medicines, including decoction pieces,
Chinese Materia Medica (raw materials) and granule forms of individual medicinals for prescriptions
(GFIMP), but not Chinese patent medicines (CPM).
Relevant coding standards for Kampo medicine, Korean medicine and other traditional medicines will
be separately formulated as needed by experts in these areas.
This part of ISO 18668-1 is suitable for decoction pieces, Chinese Materia Medica (raw materials), and
granule forms of individual medicinals for prescriptions (GFIMP) in the fields of clinical medication,
scientific research and teaching, and statistics and management.
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 15420, Information technology — Automatic identification and data capture techniques —
EAN/UPC bar code symbology specification
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
Chinese medicine
substance or combination of substances used under the guidance of traditional Chinese medicine (TCM)
theory for medical care and the prevention and treatment of disease
Note 1 to entry: This includes Chinese Materia Medica, decoction pieces, granule forms of individual medicinals
for prescriptions (GFIMP), and Chinese patent medicines (CPM).
3.2
Chinese Materia Medica
CMM
medicinal parts of medicinal plants, animals, and minerals after preliminary processing, which are
used as raw materials in Chinese medicines
Note 1 to entry: This refers to the raw materials used to make decoction pieces.
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ISO 18668-1:2016(E)
3.3
decoction piece
prescription medicinal processed from Chinese Materia Medica under the guidance of TCM and
processing methods for Chinese medicines
Note 1 to entry: Decoction pieces are directly used in clinical practice or the production of prepared medicines.
3.4
granule form of individual medicinal for prescriptions
GFIMP
granular preparation processed from single decoction piece after extraction, concentration, and drying
Note 1 to entry: This refers to a preparation of decoction pieces that can be directly dispensed without decocting.
3.5
layer
set of the characters within the code
EXAMPLE A sub-field within the code.
4 Coding principles
4.1 Uniqueness
Each variety and processed form corresponds to a unique code.
4.2 Scientific integrity
The most stable properties, attributes, or characteristics of each Chinese medicine are selected as basis
for classification and coding. The basic attributes, the main applications, as well as its quality, of each
Chinese medicine are reflected in the codes.
4.3 Scalability
The coding rules allow sufficient space for expansion.
4.4 Compatibility
The coding rules are consistent with relevant existing International Standards.
4.5 Stability
The code for each Chinese medicine remains unchanged once assigned, as long as the basic characteristic
of the medicinal does not change. Even if some Chinese medicines are discontinued for production and
use, their codes should still be kept.
5 Coding technology
5.1 Technical basis
5.1.1 Layer 1
Layer 1 with 1 digit, Chinese medicines, with the categories of agriculture, forestry, animal husbandry,
and fishery are symbolized by 0, which is developed according to central product classification (CPC)
developed by United Nations Statistical Commission.
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ISO 18668-1:2016(E)
5.1.2 Layer 2
Layer 2 with 1 digit, the product code of Chinese medicines, symbolized by 6, is developed according to
the request of CPC and GB/T 7635.1-2002. It is used to express the natural and commodity properties of
Chinese medicines, which is important for identification and trade.
5.1.3 Layer 3
Layer 3 with 1 digit, the main code of medicinal source, is encoded according to classification and
codes of plants, which is based on Linnaean taxonomy categories with the modern Five Kingdoms
classification. In layer 3, 1 refers to plant, 2 refers to animal, 3 refers to mineral, 4 refers to fungus, 5
refers to lichen, 6 refers to algae, and 7 refers to mixed kingdom.
5.1.4 Layer 4
Layer 4 with 3 digits (‘001’ to ‘999’), the subdivided code of medicinal source, indicates sources (family
or group) and serial numbers of Chinese medicines.
5.1.4.1 In the plant category, different families of plants are encoded according to a certain classification
rule from lower plants to higher plants. In layer 4, for the first digit, 1 refers to liverwort, 2 refers to moss,
3 refers to pteridophytes, 4 refers to gymnosperm, 5 and 6 refers to Archichlamydeae of dicotyledoneae,
7 refers to Sympetalae of dicotyledoneae, and 9 refers to monocotyledon. 0 and 8 are designed for future
extension as needed.
5.1.4.2 In the animal category, different families of animals are encoded according to a certain
classification rule from lower animals to higher animals, followed by Porifera, Coelenterata, Annulata,
Mollusca, Arthropoda, Ectoprocta and Phylum Chordata.
5.1.4.3 In the mineral category, groups of minerals are encoded according to a certain classification
rule from simple minerals to complex minerals, followed by Elemental mineral, Sulfides and Related
Analogues, Oxides and hydroxides, Oxysalt, Halide,Magmatic rocks, Metamorphic rocks, and Fossils.
5.1.5 Layer 5
Layer 5 with 1 digit, the main code of medicinal part, ranged from 1 to 9, in which different numbers
stand for different kinds of medicinal parts.
5.1.5.1 In the plant category, medicinal parts are divided into roots and bulbs, stems, woods, cortex
and leaves, flowers, fruits and seeds, whole plants, and other products, symbolized by 1, 2, 3, 4, 5, and 9
respectively.
5.1.5.2 In the animal category, medicinal parts are divided into 4 subdivisions. One indicates the whole
animal and eviscerated animal, 2 indicates animal skin, horn, scale, conch, 3 indicates animal skeleton
and visceral organ, 4 indicates animal product and processed goods.
5.1.5.3 In the fungus category, medicinal parts are divided into mycelium, sporocarp, and other
products, which are symbolized by 1, 2, and 9 respectively.
5.1.6 Layer 6
Layer 6 with 2 digits, the subdivided code of medicinal part, ranged from 01 to 99, is the second order
division. For instance, as a type of medicinal plant part, rhizomes and roots can be divided into 7
subdivisions such as root, fibrous root, and so on; while flowers can be divided into 6 subdivisions as
inflorescence, simple flower, flower bud, receptacle, stamen, and pistil.
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ISO 18668-1:2016(E)
5.1.7 Layer 7
Layer 7 with 3 digits, the varieties code of Chinese medicines ranged from 001 to 999 is the sequence
number of the medicinal located in the code table for Chinese medicines from the same medicinal part
of the same family.
EXAMPLE Both Decoction pieces of Arisaematis Rhizoma (code: 06191610600100005) and Pinellia Tuber
(code: 06191610600200002) are derived from Tuber of Araceae. Their codes are same from layer 1 to 6, i.e.
061916106, but codes of layer 7 are different, i.e. Arisaematis Rhizoma encoding as 001, referring as the No.001
decoction pieces derived from Tuber of Araceae, Pinellia Tuber encoding as 002, referring as the No. 002 decoction
pieces derived from Tuber of Araceae.
5.1.8 Layer 8
Layer 8 with 2 digits, ranged from 00 to 99, is used to indicate specifications of Chinese medicines.
00 indicates purifying, 01 indicates extremely thin pieces (thinner than 0,5 mm), 02 indicates thin
pieces (1 mm to 2 mm), 03 indicates thick pieces (2 mm to 4 mm) or pieces, 04 indicates segments, 05
indicates blocks, 06 indicates shreds, 07 indicates powder, 08 indicates fresh medicinal, 09 indicates
granule forms of individual medicinals for prescriptions, 99 indicates Chinese Materia Medica. If there
are more than one kind of cutting specifications of the same Chinese medicine, the commonly used one
is selected in order to reach unification. For example, Rhubarb can be specified both as piece and block,
among which block is selected to stand for the specification code.
5.1.9 Layer 9
Layer 9 with 2 digits, ranged from 00 to 99, is used to indicate the processing methods of Chinese
medicines. The first and second digits indicate processing methods and requirements respectively.
For example, 1 as the first digit indicates plain stir-frying, while 11 and 12 indicate stir-frying until
yellowish and stir-frying until brown. The number 2 as the first digit indicates stir-frying with a solid
adjuvant, while 21 indicates stir-frying with bran, 22 with sand, 23 with talcum powder, 24 with
clamshell powder, 25 with rice, 26 with soil, 27 with cattail pollen. The number 3 as the first digit
indicates stir-frying with a liquid adjuvant, while 31 indicates stir-frying with wine, 32 with vinegar.
The number 4 as the first digit indicates processing to scorch, while 41 indicates stir-frying to scorch,
42 indicates calcining to scorch. 99 indicates other processing methods.
5.1.10 Layer 10
Layer 10, is the check digit with one number, which refers to the last number calculated by a certain
kind of operation method to test the accuracy of the 16 numbers former. Check digit is calculated by the
method in ISO/IEC 15420.
5.2 Structure
Coding rules are represented by 10 layers with 17 digit Arabic numerals in order, as shown in Figure 1.
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ISO 18668-1:2016(E)
0 6 X XXX X XX XXX XX XX X
Layer 10: Check digit
Layer 9: Processing code of Chinese medicines
Layer 8: Category and speciication code of CMM, decoction pieces, and GFIMP
Layer 7: Varieties code of Chinese medicines
Layer 6: Subdivided code of medicinal part
Layer 5: Main code of medicinal part
Layer 4: Subdivided code of medicinal source
Layer 3: Main code of medicinal source
Layer 2: Product code of Chinese medicines
Figure 1 — Coding structure of Chinese medicines
5.3 Detailed description
Since Chinese Materia Medica is the raw material of decoction pieces, and decoction pieces are the basic
materials of granule forms of individual medicinals for prescriptions, when designing the coding system
for Chinese medicines, it is feasible that one set of rules could incorporate the features of both decoction
pieces and Chinese Materia Medica, since they share the same medicinal source and medicinal part. So
in the structure, layer 1 to layer 7 is the same for all three forms.
After being processed, decoction pieces and granule forms of individual medicinals for prescriptions are
different from Chinese Materia Medica (raw materials). Thus, there are some differences in structure of
the rules. Layer 8 (with 2 digits) encodes specification of medicinals. In this layer, 09 is used to express
granule forms of individual medicinals for prescriptions and 99 is used to express Chinese Materia
Medica. Layer 9 (with 2 digits) encodes processing codes of medicinals. Decoction pieces and granule
forms of individual medicinals for prescriptions have their corresponding processing methods in layer 9.
Detailed description of coding structure of Chinese medicines are shown as follows:
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ISO 18668-1:2016(E)
Table 1 — Detailed description of coding structure of Chinese medicines
Layer
Classification Digit No. Code value Note
No.
Main category of
agriculture, forestry,
Layer 1 pasture husbandry, 1 digit Chinese medicines are symbolized by 0. See 5.1.1
fishery, and Chinese
medicines
Product code of Chi- The product code of Chinese medicines is sym-
Layer 2 1 digit See 5.1.2
nese medicines bolized by 6.
For the main code of medicinal source, 1 refers
Main code of medici- to plant, 2 refers to animal, 3 refers to mineral,
Layer 3 1 digit See 5.1.3
nal source 4 refers to fungus, 5 refers to lichen, 6 refers to
algae, 7 refers to mixed kingdom.
Subdivided code of The subdivided code of medicinal source (fami- See 5.1.4 and
Layer 4 3 digits
medicinal source ly, group) ranged from 001 to 999. Annex A
Main code of medici- The main code of medicinal part ranges from 1 See 5.1.5 and
Layer 5 1 digit
nal part to 9. Annex A
Subdivided code of The subdivided code of medicinal part, ranged See 5.1.6 and
Layer 6 2 digits
medicinal part from 01 to 99, is the second order division. Annex A
The varieties code, symbolized by 3 digits, is
Varieties code of
Layer 7 3 digits the sequence number of the medicinal located See 5.1.7
Chinese medicines
in the code table, ranged from 001 to 999.
Category and
The specification code of Chinese medicines,
specification code See 5.1.8 and
Layer 8 2 digits ranged from 00 to 99, is categorized by the
of CMM, decoction Annex A
cutting type or appearance.
pieces, and GFIMP
The processing code of Chinese medicines,
Processing code of See 5.1.9 and
Layer 9 2 digits ranged from 00 to 99, is categorized according
Chinese medicines Annex A
to processing methods and varieties.
See 5.1.10 and
Layer 10 Check digit 1 digit Check digit ranges from 1 to 9.
Annex B
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ISO 18668-1:2016(E)
Annex A
(normative)
Code table of layer 4 to layer 9
Classification code of plant sources are presented in Table A.1.
Table A.1 — Classification code of plant sources (family)
Code Code Code
Source Source Source
(Layer 4) (Layer 4) (Layer 4)
Huperziaceae 301 Aizoaceae 528 Lecythidaceae 629
Lycopodiaceae 302 Portulacaceae 529 Rhizophoraceae 630
Selaginellaceae 303 Basellaceae 530 Nyssaceae 631
Lsoetaceae 304 Caryophyllaceae 531 Alangiaceae 632
Equisetaceae 305 Nymphaeaceae 532 Combretaceae 633
Psilotaceae 306 Ceratophyllaceae 533 Myrtaceae 634
Helminthostachyaceae 307 Eupteleaceae 534 Melastomataceae 635
Botrychiaceae 308 Trochodendraceae 535 Trapaceae 636
Ophioglossaceae 309 Cercidiphyllaceae 536 Onagraceae 637
Marattiaceae 310 Ranunculaceae 537 Haloragidaceae 638
Angiopteridaceae 311 Lardizabalaceae 538 Hippuridaceae 639
Christenseniaceae 312 Berberidaceae 539 Theligonaceae 640
Osmundaceae 313 Menispermaceae 540 Cynomoriaceae 641
Plagiogyriaceae 314 Magnoliaceae 541 Araliaceae 642
Gleicheniaceae 315 Calycanthaceae 542 Umbelliferae 643
Schizaeaceae 316 Annonaceae 543 Cornaceae 644
Lygodiaceae 317 Myristicaceae 544 Diapensiaceae 701
Hymenophyllaceae 318 Lauraceae 545 Clethraceae 702
Dicksoniaceae 319 Hernandiaceae 546 Pyrolaceae 703
Cyatheaceae 320 Papaveraceae 547 Ericaceae 704
Monachosoraceae 321 Cappafidaceae 548 Myrsinaceae 705
Dennstaedtiaceae 322 Cruciferae 549 Primulaceae 706
Lindsaeaceae 323 Resedaceae 550 Plumbaginaceae 707
Taenitidaceae 324 Moringaceae 551 Sapotaceae 708
Hypolepidaceae 325 Bretschneideraceae 552 Ebenaceae 709
Pteridiaceae 326 Nepenthaceae 553 Symplocaceae 710
Pteridaceae 327 Droseraceae 554 Styracaceae 711
Acrostichaceae 328 Crassulaceae 555 Oleaceae 712
Stenochlaenaceae 329 Saxifragaceae 556 Loganiaceae 713
Sinopteridaceae 330 Pittosporaceae 557 Gentianaceae 714
Adiantaceae 331 Hamamelidaceae 558
...
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