ISO 9319:2024

Traditional Chinese medicine — Poria cocos sclerotium

This document specifies the quality, safety requirements and test methods for Poria cocos sclerotium that is derived from the fungus Poria cocos (Schw.) Wolf. It is applicable to Poria cocos sclerotium sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

Médecine traditionnelle chinoise — Poria cocos sclerotium

General Information

• Status: Published
• Publication Date: 08-Feb-2024
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 09-Feb-2024
• Due Date: 24-Nov-2024
• Completion Date: 09-Feb-2024

Standards Content (Sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9319
ISO/TC 249
Traditional Chinese medicine — Poria
Secretariat: SAC
cocos sclerotium
Voting begins on:
2023-11-06
Médecine traditionnelle chinoise — Poria cocos sclerotium
Voting terminates on:
2024-01-01
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 9319:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 9319:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9319
ISO/TC 249
Traditional Chinese medicine — Poria
Secretariat: SAC
cocos sclerotium
Voting begins on:
Médecine traditionnelle chinoise — Poria cocos sclerotium
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 9319:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 9319:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics . 2
5.2 Morphological features . 3
5.2.1 Whole poria . 3
5.2.2 Cubic poria . 3
5.2.3 Sliced poria . 3
5.3 Microscopic identification .
...

ISO/FDIS 9319: 2023(E)
DATE: 2023-08-15
ISO/TC 249
Secretariat: SAC
Date: 2023-10-23
Traditional Chinese medicine — Poria cocos sclerotium
Médecine traditionnelle chinoise — Poria cocos sclerotium
FDIS stage

---------------------- Page: 1 ----------------------
ISO/FDIS 9319:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: [phone]
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ii © ISO 2023 – All rights reserved
 © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 9319:2023(E)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.2.1 Whole poria . 3
5.2.2 Cubic poria . 3
5.2.3 Sliced poria . 3
5.3 Microscopic identification . 4
5.4 Thin-layer chromatography (TLC) . 4
5.5 Chemical colour reaction . 4
5.6 Moisture . 4
5.7 Total ash . 5
5.8 Extractives . 5
5.8.1 Ethanol-soluble extractives . 5
5.8.2 Water-soluble extractives . 5
5.9 Content of marker compound(s) . 5
5.10 Heavy metals .
...