ISO 19610:2017

Traditional Chinese medicine — General requirements for industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer)

This document specifies the general requirements for the industrial manufacturing process of red ginseng from Panax ginseng C.A. Meyer which is the only species from which red ginseng is processed[6-11]. It is intended that manufacturers perform the appropriate washing, steaming, drying and packaging processes to assure the quality of red ginseng products for consumers.

Médecine traditionnelle chinoise — Exigences générales pour le procédé de fabrication industrielle du ginseng rouge (Panax ginseng C.A. Meyer)

General Information

• Status: Published
• Publication Date: 11-Apr-2017
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9093 - International Standard confirmed
• Start Date: 30-Mar-2023
• Completion Date: 12-Feb-2026

Overview

ISO 19610:2017 specifies general requirements for the industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer). It covers the full processing chain - from fresh ginseng harvested after 4–6 years of cultivation through washing, steaming, drying and packaging - to ensure product quality and consumer safety. The standard is produced by ISO/TC 249 (Traditional Chinese medicine) and is intended for manufacturers and stakeholders in the red ginseng supply chain.

Key Topics and Requirements

• Starting material
  • Fresh ginseng cultivated for four to six years is defined as the starting material.
  • Control of pesticide residues and heavy metals in accordance with applicable domestic and international regulations (see ISO 18664:2015 for heavy metal guidance).
• Factory environment
  • Facilities shall be designed to reduce contamination risk during processing.
• Machines and equipment
  • Equipment in contact with ginseng must be appropriately designed and maintained.
  • Critical equipment functions include:
    • Washing machines: adequate spray pressure and full-surface cleaning without damaging roots.
    • Steaming machines: generation of saturated steam, temperature control and even steam distribution.
    • Drying machines: controlled temperature and humidity with uniform air flow.
    • Packaging machines: hygienic packaging compatible with ISO 14159 (hygiene requirements for machinery).
• Process controls
  • Washing: use drinking-quality water meeting WHO Guidelines for Drinking-water Quality; tumblers or low-damage conveyor washers recommended; visual rewash if necessary.
  • Steaming: key to starch gelatinization (note: gelatinization observed between ~61 °C and 88 °C for purified starch - higher temperatures may be needed for whole ginseng); steaming conditions should be adjusted based on root diameter (size classification).
  • Drying: hot-air or sunlight drying until appropriate moisture content is achieved to improve storage stability.
• Packaging and labelling
  • Appropriate packaging to protect product quality, with clear labelling including expiration date, lot number and other traceability data.

Applications and Who Uses It

ISO 19610:2017 is practical for:

• Red ginseng manufacturers implementing standardized industrial processes and good manufacturing practices (GMP).
• Quality managers and production engineers designing washing, steaming and drying lines.
• Equipment designers and suppliers specifying machinery performance (cleanability, temperature/humidity control, hygiene).
• Regulators, auditors and importers assessing compliance with hygienic processing and labelling/traceability requirements.
• Traditional Chinese medicine (TCM) product developers ensuring consistent product quality from Panax ginseng.

Related Standards

• ISO 14159 - Safety of machinery: hygiene requirements for machine design (referenced for equipment).
• WHO Guidelines for Drinking-water Quality - used for washing water quality.
• ISO 18664:2015 - referenced for heavy metal information (see notes in ISO 19610).

Keywords: ISO 19610:2017, red ginseng, Panax ginseng, industrial manufacturing, Traditional Chinese Medicine, washing, steaming, drying, packaging, quality control, ISO 14159, WHO drinking water.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 19610
First edition
2017-04
Traditional Chinese medicine —
General requirements for industrial
manufacturing process of red ginseng
(Panax ginseng C.A. Meyer)
Médecine traditionnelle chinoise — Exigences générales pour le
procédé de fabrication industrielle du ginseng rouge (Panax ginseng
C.A. Meyer)
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
4.1 Starting material . 2
4.1.1 Pesticides . 2
4.1.2 Heavy metals . 2
4.2 Factory environment . 2
4.3 Machines . . 2
4.3.1 General. 2
4.3.2 Washing machine . 2
4.3.3 Steaming machine . . 3
4.3.4 Drying machine . 3
4.3.5 Packaging machine. 3
5 Industrial manufacturing process of red ginseng . 4
5.1 General . 4
5.2 Washing . 5
5.2.1 General. 5
5.2.2 Quality of water . 5
5.2.3 Washing procedure . 5
5.3 Steaming . 5
5.3.1 General. 5
5.3.2 Classification for steaming . 5
5.3.3 Steaming condition . 6
5.4 Drying . 7
5.4.1 General. 7
5.4.2 Drying guidelines . 7
5.4.3 Hot air drying . . . 7
5.4.4 Sun drying . 7
6 Packaging and labelling . 7
6.1 General . 7
6.2 Packaging . 8
6.3 Labelling . 8
6.3.1 General. 8
6.3.2 Expiration date . 9
Bibliography .10
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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 19610:2017(E)
Traditional Chinese medicine — General requirements for
industrial manufacturing process of red ginseng (Panax
ginseng C.A. Meyer)
1 Scope
This document specifies the general requirements for the industrial manufacturing process of
red ginseng from Panax ginseng C.A. Meyer which is the only species from which red ginseng is
[6-11]
processed . It is intended that manufacturers perform the appropriate washing, steaming, drying
and packaging processes to assure the quality of red ginseng products for consumers.
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 14159, Safety of machinery — Hygiene requirements for the design of machinery
WHO Guidelines for drinking-water quality, fourth edition
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 http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
fresh ginseng
ginseng root harvested from the field, before being washed
3.2
washed ginseng
raw ginseng root washed with drinking water to remove any foreign matter and which is then used as
the starting material for manufacturing red ginseng
3.3
steamed ginseng
ginseng produced through a process of steaming the washed ginseng to gelatinize the starch content
3.4
red ginseng
ginseng root from Panax ginseng C.A. Meyer, treated with steam and then dried and packaged as whole
or cut roots
3.5
cultivated years
number of years of cultivation after budding seeds
3.6
for
...