ISO 23963-2:2022 PDF

Name: ISO 23963-2:2022 — Traditional Chinese medicine — Requirements for process traceability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling
SKU: ISO 23963-2:2022
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Traditional Chinese medicine — Requirements for process traceability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling

Название (английский):

ISO 23963-2:2022

Traditional Chinese medicine — Requirements for process traceability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 1 августа 2022 г.
Издание:: ISO IS 23963 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 23963-2:2022 defines the required content and management principles for electronic labelling presented as QR codes on outer packaging of Chinese materia medica and decoction pieces. The standard applies across the supply chain - cultivation, production, sales, clinical use units and consumers - and supports a standardized traceability system that improves product transparency, quality assurance and consumer confidence.

Key Topics

QR code content and format: Electronic labelling is delivered via QR codes and displays text, graphics and instructions after scanning (electronic labelling). The content must be fixed and only editable through a trusted third‑party platform independent of supply‑chain operators.

Unique batch linkage: Each batch of materia medica or decoction pieces shall correspond to a unique electronic label. The label language must be the official language of the destination country.

Mandatory data fields: The QR payload shall include standardized data for rapid verification and compliance. Essential items listed by the standard include:

Product name (per ISO 18668‑2 / ISO 18668‑3)
Barcode (per ISO 20333)
17‑bit code for materia medica and decoction pieces (ISO 18668 series)
Brand and registered trademark
Place of origin (county level, per ISO 20333)
Harvest time and other product timestamps (YYYY-MM-DD)
Processing method, specification (g/pack), efficacy, adverse reactions and contraindications
Manufacturer and distributor details: registered name, full address (door number), telephone (country code–area–number) and website (standard web format)
Packing / product times with date format YYYY-MM-DD
Additional info: storage method (per ISO 22217), applied standards, product images, decocting and administration methods

Governance rules: Organizations providing labelling must act as trusted third parties; users shall not modify label content directly. If multiple distributors exist, their information can be added.

Applications

Enables end‑to‑end supply‑chain traceability for traditional Chinese medicine products.

Supports regulatory compliance, internal quality control and supplier evaluation.

Provides consumers and clinicians with accessible product information (origin, processing, usage and safety data) by scanning a QR code.

Facilitates internationalization and standardization of Chinese materia medica and decoction pieces by harmonizing data presentation.

Related Standards

ISO 23963-2 references and is consistent with related documents used for coding and handling of TCM products:

ISO 23963-1 - Components of the traceability system

ISO 18668-2 / ISO 18668-3 - Coding systems for decoction pieces and materia medica

ISO 20333 - Coding rules for supply chain management

ISO 22217 - Storage requirements for raw materials and decoction pieces

Follow ISO 23963-2:2022 to implement robust QR-based electronic labelling that enhances traceability, consumer safety and product transparency for traditional Chinese medicine.

ISO 23963-2:2022 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

BS ISO 18668-2:2017

Coding system of Chinese medicines. Codes of decoction pieces.

BS ISO 18668-3:2017

Traditional Chinese medicine. Coding system for Chinese medicines. Codes for Chinese Materia Medica.

ISO 20333:2017

Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain management

ISO 22217:2020

Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces

ISO 23963-1:2022

Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and de…