ISO 22256:2020
(Main)Traditional Chinese medicine - Detection of irradiated natural products by photostimulated luminescence
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
Overview
ISO 22256:2020 is an international standard that defines a method for detecting irradiation in traditional Chinese medicinal natural products using photostimulated luminescence (PSL). This standard is essential for ensuring the authenticity and safety of raw and processed Chinese medicinal materials by identifying whether they have been exposed to ionizing radiation such as gamma rays, X-rays, or electron beams. The method is applicable mainly to solid forms of medicinal products containing crushed natural materials and excludes liquid or partially solid extracts without direct solid material content.
The adoption of this standard helps regulatory bodies, manufacturers, and traders to monitor and verify the radiation status of traditional Chinese medicine (TCM) products. Through reliable detection, ISO 22256:2020 supports compliance with international trade regulations and prevents the use of irradiated materials, thereby maintaining product quality.
Key Topics
- Photostimulated Luminescence (PSL) Method: Utilizes light stimulation to release trapped energy stored in minerals like silicates and calcite present in medicinal products, resulting in luminescence detectable by specialized instruments.
- Sample Preparation: Grinding natural product samples to a fine powder with specific sample mass (typically 2 grams) placed in standardized Petri dishes for uniform testing.
- Instrument Calibration: Includes operational parameters such as acquisition frequency, dark count limits, and use of positive and negative irradiated reference materials for accurate measurement.
- Screening and Confirmation: The method consists of a two-step approach-initial screening PSL measurement followed by calibrated PSL post-irradiation with a known radiation dose to calculate the F-factor.
- Result Interpretation: F-factor (ratio of calibrated PSL to screening PSL) is critical to categorize samples as irradiated or non-irradiated, minimizing false positives by requiring repeated analysis if results are borderline.
- Limitations: Not applicable to liquid dosage forms or solid extracts lacking crushed materials; sample handling guidelines are provided to avoid contamination and sample degradation.
Applications
ISO 22256:2020 is designed primarily for:
- Regulatory Authorities: To enforce radiation restrictions on traditional Chinese medicine products and ensure compliance with safety regulations.
- Manufacturing Quality Control: Enabling manufacturers to verify the radiation status of raw materials and finished solid dosage forms, ensuring product integrity.
- Customs and Import Inspection: Providing inspection agencies with a rapid, cost-effective screening method to identify irradiated TCM products and prevent unauthorized imports.
- Research and Development: Assisting in the development of non-irradiated processing techniques by confirming irradiation status.
- International Trade: Facilitating smoother trade negotiations and reducing disputes related to non-compliant radiation treatment of natural products.
Related Standards
When implementing ISO 22256:2020, the following complementary standards may be relevant:
- EN 13751:2009 – Foodstuffs - Detection of irradiated food using photostimulated luminescence, providing foundational PSL definitions and methodologies.
- EN 1788:2001 – Foodstuffs - Thermoluminescence detection of irradiated food, useful for detecting silicate minerals isolated from foods.
- USP <2250> – Detection of irradiated dietary supplements as per the United States Pharmacopeia standards.
- Research publications such as Zhang et al. (2013) provide refined PSL criteria tailored to traditional Chinese medicinal herbs.
Keywords: ISO 22256:2020, traditional Chinese medicine, photostimulated luminescence, PSL detection, irradiated natural products, ionizing radiation detection, gamma radiation, X-ray, beam radiation, TCM product safety, radiation status identification, quality control in Chinese medicine, medicinal material irradiation, international trade compliance.
Frequently Asked Questions
ISO 22256:2020 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine - Detection of irradiated natural products by photostimulated luminescence". This standard covers: 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.
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.
ISO 22256:2020 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
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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 2020
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved
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
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv © ISO 2020 – All rights reserved
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
...
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