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

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Publication Date
22-Mar-2016
Current Stage
9093 - International Standard confirmed
Start Date
02-Dec-2021
Completion Date
02-Dec-2021
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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
---------------------- Page: 1 ----------------------
ISO 18668-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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ii © ISO 2016 – All rights reserved
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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

© ISO 2016 – All rights reserved iii
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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

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).

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.

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
iv © ISO 2016 – All rights reserved
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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.
© ISO 2016 – All rights reserved v
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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.

4 © ISO 2016 – All rights reserved
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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:

© ISO 2016 – All rights reserved 5
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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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