ISO 22256-2020 PDF

Full title and description

ISO 22256:2020 — Traditional Chinese medicine — Detection of irradiated natural products by photostimulated luminescence. This international standard specifies a photostimulated luminescence (PSL) screening and confirmation method to determine whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured products made from these materials have been irradiated by ionizing radiation (gamma, X‑ray or electron beam).

Abstract

This standard defines a PSL-based procedure for screening samples of natural materials used in traditional Chinese medicine (TCM) to detect prior exposure to ionizing radiation. It covers sample preparation (solid/crushed materials), initial PSL screening, and, where required, calibrated post-irradiation PSL to calculate an F‑factor for confirmation. The method is not applicable to liquid dosage forms or partially solid extracts that do not contain directly crushed medicinal materials.

General information

• Status: Published.
• Publication date: July 2020 (Edition 1, 2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.120.10 — Medicaments.
• Edition / version: Edition 1 (2020).
• Number of pages: 5.

Core bibliographic and lifecycle metadata as listed by ISO.

Scope

ISO 22256:2020 applies to the detection of irradiation in natural products used in TCM by means of photostimulated luminescence. It is intended for testing raw materials, decoction pieces and solid manufactured forms that contain directly crushed medicinal materials. The method provides a rapid screening step (PSL screening) and a calibrated confirmation procedure (post-irradiation PSL and F‑factor calculation) to reduce false positives. It explicitly excludes liquid dosage forms and partially solid extracts that lack crushed material.

Key topics and requirements

• Photostimulated luminescence (PSL) screening protocol for rapid detection of irradiation signals in solid natural-product samples.
• Sample preparation requirements (grinding to produce representative, testable solid material and standardized sample mass and geometry for measurement).
• Instrument calibration and use of reference (positive and negative) materials for method validation and quality control.
• Two-step approach: initial PSL screening followed, when indicated, by calibrated PSL post-irradiation to compute an F‑factor for confirmation.
• Decision criteria/interpretation rules for classifying samples as irradiated, not irradiated, or requiring repeat/alternative testing.
• Limitations and exclusions: not applicable to liquids or extracts lacking crushed material; attention to contamination and handling to avoid spurious luminescence.

Technical details and measurement/interpretation rules are described in the standard text.

Typical use and users

Primary users include analytical and quality‑control laboratories testing traditional Chinese medicinal materials, manufacturers of TCM products, regulatory and public‑health authorities, customs and border inspection services screening imports, and research groups studying treatment or processing effects. The standard is used to screen supply chains, verify labelling claims about irradiation, and support safety and compliance programmes for TCM materials.

Related standards

ISO 22256:2020 is part of the ISO/TC 249 body of standards on traditional Chinese medicine and is referenced alongside other test and quality standards such as ISO 22258:2020 (determination of pesticide residues in natural products by gas chromatography) and related quality/safety documents (for example, parts of ISO 19609 series on quality and safety testing). Users commonly apply ISO 22256 together with other analytical standards addressing contaminants, residues and identity testing.

Keywords

Traditional Chinese medicine; TCM; photostimulated luminescence; PSL; irradiated products; ionizing radiation detection; gamma irradiation; X‑ray; electron beam; screening method; F‑factor; sample preparation; quality control.

FAQ

Q: What is this standard?

A: ISO 22256:2020 is an international standard that specifies a photostimulated luminescence (PSL) method to detect whether natural products used in traditional Chinese medicine have been irradiated by ionizing radiation.

Q: What does it cover?

A: It covers sample preparation and measurement procedures for solid/crushed natural-product samples, an initial PSL screening step, and a calibrated confirmation step (post‑irradiation PSL and F‑factor calculation). It does not cover liquids or partially solid extracts without crushed material.

Q: Who typically uses it?

A: Analytical laboratories, TCM manufacturers, regulatory authorities, customs/border inspection agencies, and researchers concerned with product safety, labelling and supply‑chain verification.

Q: Is it current or superseded?

A: The document was published in July 2020 (Edition 1) and is listed as a published ISO standard. Users should check national adoption or any subsequent amendments or replacements in their national standards catalogue; as published by ISO the 2020 edition is the authoritative edition.

Q: Is it part of a series?

A: It is part of the ISO/TC 249 suite of standards addressing quality, safety and test methods for traditional Chinese medicine; it is commonly used alongside other analytical standards (for example ISO 22258:2020 and related quality/testing parts).

Q: What are the key keywords?

A: Photostimulated luminescence (PSL), irradiation detection, traditional Chinese medicine, irradiated natural products, screening method, F‑factor, ionizing radiation (gamma/X‑ray/electron beam), sample preparation, quality control.