ISO/TC 249 - Traditional Chinese medicine

This document specifies general requirements for the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.

This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.

This document specifies general requirements for the basic safety and essential performance of transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate acupoints on the human body. It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context of professional traditional Chinese medicine (TCM) healthcare services. It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via acupuncture needles inserted into the body.

This document specifies the general requirements and test methods of Chuzhen instruments. It is only applicable to non-disposable Chuzhen instruments. It is not applicable for any disposable Chuzhen instruments or for those with electrical, heat-storing, or other special characteristics.

This document specifies the minimum requirements and test methods for Sophora tonkinensis root and rhizome. This document applies to Sophora tonkinensis root and rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the safety and quality requirements for herbal dispensing services. It is applicable to facilities related to large-scale herbal dispensaries, in-house hospital dispensaries and medium to large commercial dispensaries. It does not apply to dispensing services in medical clinics where herbal preparations are dispensed to patients by or under the supervision of the prescribing practitioners. The specifications regarding tools and equipment used in these services are excluded.

This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is derived from Schisandra chinensis (Turcz.) Baill. It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.

This document provides vocabularies and definitions for moxibustion devices. This document is not applicable to moxibustion-like devices whose heat source is not combustion, e.g. electric moxibustion devices.

This document specifies the requirements and test methods for Salvia miltiorrhiza root and rhizome, which are derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that are sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.

This document specifies the minimum requirements and test methods for Areca catechu seed. This document applies to Areca catechu seed 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. This document does not apply to processed decoction pieces of Areca catechu seed.

This document specifies the technical requirements for the quality and safety of industrial manufacturing procedures and quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. It is applicable to Salvia miltiorrhiza root and rhizome aqueous extract granules that are sold and used in international trade.

This document specifies the minimum requirements and test methods for Isatis indigotica root derived from the plant Isatis indigotica Fort. It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the general requirements, content and writing requirements for the prescription of decoction pieces. It notably regulates the qualification of prescription writing, the prescription of precious medicines, the prescription of toxic and anaesthetic medicines, and institution-based prescriptions. This document applies to prescription writing, dispensing and storage.

This document specifies the minimum requirements and test methods for Ziziphus jujuba fruit. This document is applicable to Ziziphus jujuba fruit that is sold and used as herbal raw materials in the international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.

This document specifies the general principles for the establishment of herbal reference substances, covering production, quality control, report, instruction and labelling, packaging, storage and transportation. This document applies to herbal reference substances that are sold and used as reference standards for the quality control of herbal medicines in international trade, including raw materials and finished products.

This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the general technical requirements for the process of cultivation and collection of medicinal plants, including selection of site, seeds and other propagation materials, cultivation, harvest and collection, post-harvest processing, packaging and labelling, storage and transportation. This document applies to the cultivation, harvest and collection of medicinal plants used as the source for herbal medicines, including certain post-harvest operations. This document also provides practical record formats for the entire process.

This document specifies the minimum quality and safety requirements for Crocus sativus stigma. It applies to Crocus sativus stigma that is sold and used as natural medicines in international trade, including in Chinese materia medica and decoction pieces.

This document specifies the quality, safety requirements and test methods for Euodia fruit. It is applicable to Euodia fruit that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

This document specifies requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to the Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.

This document specifies requirements and test methods for Curcuma rhizome (Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome). It is applicable to the Curcuma 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. This document does not apply to the processing methods and processed products of Curcuma rhizome.

This document specifies the quality and safety requirements of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome. This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole medicinal material, and in decoction pieces derived from these plants.

This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.

This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

This document defines terms for abdominal diagnosis. The equivalent terms in Chinese characters (Pinyin), Japanese characters and Korean characters are given in Annex A.

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.

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.

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.