ISO 22256:2020

Traditional Chinese medicine — Detection of irradiated natural products by photostimulated luminescence

This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicinal materials.

Médecine traditionnelle chinoise — Détection des produits naturels irradiés par luminescence photostimulée

General Information

• Status: Published
• Publication Date: 13-Jul-2020
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 6060 - International Standard published
• Start Date: 14-Jul-2020
• Due Date: 21-Mar-2020
• Completion Date: 14-Jul-2020

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 22256
First edition
2020-07
Traditional Chinese medicine —
Detection of irradiated natural
products by photostimulated
luminescence
Médecine traditionnelle chinoise — Détection des produits naturels
irradiés par luminescence photostimulée
Reference number
ISO 22256:2020(E)
©
ISO 2020

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ISO 22256:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 22256:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative reference . 1
3 Terms and definitions . 1
4 Principle . 2
5 Apparatus . 2
6 Procedure. 2
6.1 General . 2
6.2 Sampling technique . 2
6.2.1 General operation . 2
6.2.2 Sample quantity . 2
6.3 Instrumental calibration. 3
6.3.1 Instrumental parameter . 3
6.3.2 Dark count . 3
6.3.3 Empty chamber test . 3
6.3.4 Negative reference count . 3
6.3.5 Positive reference count . 3
6.4 Detection of the sample . 3
6.4.1 Screening PSL . 3
6.4.2 Calibrated PSL . 3
6.4.3 F-factor calculating . 3
6.5 Result evaluation . 3
7 Other requirements . 4
7.1 Limitation of application . 4
7.2 Repeated determination . 4
7.3 Cleaning of sample chamber . 4
7.4 Cleaning of translucent glass . 4
7.5 Influencing factors of threshold and F-factor . 4
Bibliography . 5
© ISO 2020 – All rights reserved iii

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ISO 22256:2020(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
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 of 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 www .iso .org/
iso/ foreword .html.
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
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

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ISO 22256:2020(E)

Introduction
Ionizing radiation (gamma ray, X-ray or beam) is used extensively for the sterilization of medical devices
and for a variety of other materials and products. However, irradiation of traditional natural products
for sanitation purposes is not permitted by the regulations of most countries. It is necessary to set
up a method to identify whether a product has been subjected to irradiation, because overex
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22256
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Detection of irradiated natural
Voting begins on:
2020­04­14 products by photostimulated
luminescence
Voting terminates on:
2020­06­09
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 22256:2020(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 2020

---------------------- Page: 1 ----------------------
ISO/FDIS 22256:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
CH­1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 22256:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative reference . 1
3 Terms and definitions . 1
4 Principle . 2
5 Apparatus . 2
6 Procedure. 2
6.1 General . 2
6.2 Sampling technique . 2
6.2.1 General operation . 2
6.2.2 Sample quantity . 2
6.3 Instrumental calibration. 3
6.3.1 Instrumental parameter . 3
6.3.2 Dark count . 3
6.3.3 Empty chamber test . 3
6.3.4 Negative reference count . 3
6.3.5 Positive reference count . 3
6.4 Detection of the sample . 3
6.4.1 Screening PSL . 3
6.4.2 Calibrated PSL . 3
6.4.3 F­factor calculating . 3
6.5 Result evaluation . 3
7 Other requirements . 4
7.1 Limitation of application . 4
7.2 Repeated determination . 4
7.3 Cleaning of sample chamber . 4
7.4 Cleaning of translucent glass . 4
7.5 Influencing factors of threshold and F-factor . 4
Bibliography . 5
© ISO 2020 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/FDIS 22256:2020(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
committee has been established has the right to be represented on that committee. International
organizations, governmental and non­governmental, 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 of 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 www .iso .org/
iso/ foreword .html.
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
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/FDIS 22256:2020(E)

Introduction
Ionizing radiation (gamma ray, X-ray or beam) is used extensively for the sterilization of medical devices
and for a variety of other materials and products. However, irradia
...