ISO/TC 249 - Traditional Chinese medicine
Standardization in the field of medical systems derived from ancient Chinese medicine which shall be able to share one common set of standards. Both traditional and modern aspects of these systems are covered. The committee focuses on quality and safety of raw materials, manufactured products and medical devices and of informatics, including service standards limited to involving the safe use and delivery of devices & medicine, but not into the clinical practice or application of those products.
Médecine traditionnelle chinoise
Normalisation dans le domaine des pratiques médicales dérivées de la médecine chinoise ancestrale qui doivent pouvoir partager un ensemble commun de normes. Les aspects tant traditionnels que modernes de ces pratiques sont couverts. Le comité met l'accent sur la qualité et la sécurité des matières premières, des produits manufacturés et des dispositifs médicaux ainsi que de l'informatique, y compris les normes de service limitées à l'implication de l'utilisation et de la fourniture de dispositifs et médicaments en toute sécurité, mais pas dans la pratique ou l'application clinique de ces produits.
General Information
This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber. This document applies to Aconitum carmichaelii parent root tuber that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods and processed products of Aconitum carmichaelii parent root tuber are excluded.
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This document specifies the quality and safety requirements and test methods of Polygonum multiflorum root, which is derived from the dried root of Polygonum multiflorum Thunb. (Fam. Polygonaceae). This document is applicable to raw and processed Polygonum multiflorum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard17 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
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This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural medicine and raw material for health products in international trade.
- Technical specification17 pagesEnglish languagesale 15% off
This document specifies the methods for microscopic examination of medicinal herbs. It covers the equipment, sampling, preparation and observation methods. This document is applicable to medicinal herbs used in traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants. It is not applicable to medicinal materials derived from animals or minerals.
- Technical specification10 pagesEnglish languagesale 15% off
This document specifies the requirements and test methods of Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and seedlings. This document is applicable to Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and Glycyrrhiza uralensis seedlings that are sold for the production of Glycyrrhiza uralensis and Glycyrrhiza glabra root as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Dioscorea opposita rhizome (dried rhizome of Dioscorea opposita Thunb.). It is applicable to Dioscorea opposita rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
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This document specifies the minimum requirements and test methods for Polygala tenuifolia and Polygala sibirica root. It applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
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This document specifies the quality and safety requirements for Cinnamomum cassia branch derived from Cinnamomum cassia Presl. This document is applicable to Cinnamomum cassia branch that is sold as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces derived from Cinnamomum cassia Presl.
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This document provides a reference of single herbal medicines in order of their priority in the development of international standards. This document also provides a reference of the principles and the methodology for the priority evaluation of single herbal medicines. In addition to text written in the official ISO languages (English, French, Russian), this document gives text in Chinese. This text is published under the responsibility of the Member Body for China (SAC) and is given for information only. Only the text given in the official languages can be considered as ISO text.
- Technical report97 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Carthamus tinctorius flower that is derived from Carthamus tinctorius Linné. It is applicable to Carthamus tinctorius flower that is sold and used as Chinese materia medica.
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This document specifies test methods for the quality assessment of moxa floss. It covers sample preparation, measurement and calculation of the concentration of waste particle, and delivery of moxa floss quality information. This document is applicable to any moxa floss products and moxa floss used in the moxibustion devices. It is not applicable to the moxa floss which is hardened with chemical ingredients or high pressure, or both, and carbonized moxa floss which is used for smokeless moxibustion devices. Classification of quality grade of moxa floss is not specified in this document.
- Technical specification10 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. (Fam. Fabaceae). This document applies to Glycyrrhiza root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the application of simplified accelerated stress simulation methods for stress tests of finished products, used in and as Traditional Chinese medicine (TCM). Testing for stability or degradation under the influence of daylight or sunlight is outside the scope of this document.
- Standard23 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark. It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces. It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.
- Standard16 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is derived from Atractylodes macrocephala Koidz. It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
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This document specifies the configuration, dimensions, parameters, requirements and test methods of a sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and storage. This document excludes requirements for the handle of a three-edge needle, which is structurally different from the body of a three-edge needle.
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This document specifies the quality and safety requirements for Curcuma longa rhizome. This document applies to the production and sale of cultivated Curcuma longa rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
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This document defines terms for abdominal diagnosis. The equivalent terms in Chinese characters (Pinyin), Japanese characters and Korean characters are given in Annex A.
- Technical specification20 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Gardenia jasminoides fruit, which is derived from the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae). This document is applicable to Gardenia jasminoides fruit that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.]. This document applies to Angelica dahurica root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
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This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.
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This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
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This document reports on the global industry and standardization development of Panax ginseng. It includes its origin and application history, medicinal value, geographical distribution, cultivation and processing methods, industry development, international trade, current status and development demands for standardization.
- Technical report32 pagesEnglish languagesale 15% off
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.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the requirements and test methods for dried Rehmannia glutinosa root that is derived from Rehmannia glutinosa Libosch. Fresh Rehmannia glutinosa Libosch. and processed Rehmannia glutinosa Libosch. are excluded. This document is applicable to Rehmannia glutinosa root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard20 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods of Artemisia argyi leaf for medicinal use. It is suitable for identification and quality control of this herbal medicine.
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This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge. (Fam. Ephedraceae). This document applies to Ephedra herbaceous stem that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
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This document specifies requirements for the inner pack of decoction pieces of Chinese medicines, including packaging materials, physical properties, specifications and labels. This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision and management of inner pack of decoction pieces.
- Standard8 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Pinellia ternata tuber, including raw and processed Pinellia ternata tuber [dried tuber of Pinellia ternata (Thunb.) Breit.]. This document does not cover processing methods of Pinellia ternata tuber. This document is applicable to raw and processed Pinellia ternata tuber that are sold and used as natural medicines in international trade, including Chinese materiamedica (whole medicinal material) and decoction pieces derived from this plant.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.
- Standard21 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.
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This document specifies the requirements and test methods of single-use acupoint magnetotherapy plasters. For devices containing other medicine ingredients, this document only applies to the magnetotherapy functions of the device.
- Standard8 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies the determination of ochratoxin A (OTA) in natural products by the liquid chromatography coupled with fluorescence detector (LC-FLD) method. It is applicable to the analysis of OTA in raw materials and manufactured products, including decoction pieces derived from plants and animals. It is suitable for samples during the processes of harvesting, transportation and storage, as well as domestic and foreign trade for quality classification.
- Technical specification8 pagesEnglish languagesale 15% off
This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.
- Standard22 pagesEnglish languagesale 15% off
This document specifies safety controls for cupping devices used for air suction or discharge. It applies to cupping devices that contain cups made of manufactured materials, such as plastic, glass, rubber, ceramic or silicone. It does not apply to cupping devices that contain cups made from natural materials (e.g. bamboo) or those that include additional features, such as magnetism or infrared.
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This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).
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This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk. It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard18 pagesEnglish languagesale 15% off
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.
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This document specifies the requirements for process traceability systems in Chinese materia medica and decoction pieces, including checkpoints of traceability information about the planting or breeding and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of decoction pieces.
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This document specifies general requirements for the basic safety and essential performance of electro-acupuncture (EA) stimulators. It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical nerve and muscle stimulators.
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This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller-type dermal needles. It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.
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This document specifies the particular requirements for the basic safety and essential performance of tapping-type dermal needles for single use. It applies to tapping-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of tapping-type dermal needles. It does not apply to roller-type dermal needles, reusable tapping-type dermal needles or devices incorporating a detachable tapping head.
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This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.
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This document aims to specify a categorial structure in the field of disorder representation in traditional Chinese medicine (TCM) by defining a set of domain constraints for use within terminological resources. It contains a concept detailing the domains of four subcategories: body parts, causative agents, pathological process and manifestation. This document does not include: — a comprehensive categorial structure for TCM; — a treatment procedure for TCM; — relevant devices; — terms or descriptions for subcategories of body parts, causative agents, pathological process or manifestation.
- Technical specification7 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root. This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard20 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
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This document specifies the minimum requirements and test methods for white peony root derived from the plant of Paeonia lactiflora Pallas. It is applicable to white peony root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to red peony root.
- Standard13 pagesEnglish languagesale 15% off





