ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing

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 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 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 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 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 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 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 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 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 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 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 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 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.

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.

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.

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.

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.

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.

This document specifies the quality and safety requirements of Zingiber officinale rhizome derived from the plant Zingiber officinale Roscoe, including the minimum requirements and test methods. This document applies to Zingiber officinale 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. It is not applicable to Zingiber officinale rhizome sold and used as food or spices.

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived from the plant Glehnia littoralis Fr Schmidt ex Miq. This document applies to Glehnia littoralis 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 plant.

This document specifies the general requirements and test methods for herbal raw material and materia medica. This document provides minimum requirements for those herbal materials that are not covered by individual standards.

This document specifies minimum requirements and test methods for processed Aconitum carmichaelii lateral root (lateral root of Aconitum carmichaelii Debx.). This document applies to processed Aconitum carmichaelii lateral root 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 of Aconitum carmichaelii lateral root are excluded.

This document specifies the minimum requirements and test methods for Lycium barbarum and Lycium chinense fruit, which is derived from the plant of Lycium barbarum L. or Lycium chinense Mill. It is applicable to Lycium barbarum and Lycium chinense fruit that is sold and used as herbal raw materials in the international trade, including unprocessed and traditionally processed materials.

This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus 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 plant.

This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis 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.

This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.

This document specifies minimum requirements and test methods for Lonicera japonica flower, which is derived from the plant Lonicera japonica Thunb. It is applicable to Lonicera japonica flower that is sold and used as traditional Chinese medicine.

ISO 18664:2015 specifies determination methods of lead (Pb), arsenic (As), cadmium (Cd) and mercury (Hg) in herbal medicines used in Traditional Chinese Medicine (TCM). It is applicable to natural materials of TCM that are sold and used as food supplements, functional foods or natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to mineral drugs used in TCM. ISO 18664:2015 is not intended to set maximum limits (ML) for individual nations; rather, it is intended to give a reference for standardized testing method and risk assessment.

This document specifies the minimum requirements and test methods for Polygonati rhizome, which is derived from the plant of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red., and Polygonatum cyrtonema Hua (Fam. Liliaceace). This document is applicable to Polygonati rhizome 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 this plant.

This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.

This document specifies minimum requirements and test methods for Lonicera japonica flower, which is derived from the plant Lonicera japonica Thunb. It is applicable to Lonicera japonica flower that is sold and used as traditional Chinese medicine.

This proposal specifies minimum requirements and test methods for Leonurus japonicus herb [the dried aerial part of Leonurus japonicus Houtt.]. It is applicable to Leonurus japonicus herb 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 minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis 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.

This document specifies the minimum requirements and test methods of Coix lacrymajobi var. mayuen seed [the dried ripe seed of Coix lacryma-jobi L. var. maj/uew（Roman.）Stap. This document applies to Coix lacrymajobi var. mayuen seed that are sold and used as natural medicines in international trade, including Chinese materia medica.

This document specifies the minimum requirements and test methods for C. reticulata pericarp, which is the dried pericarp of the ripe fruit of C. reticulata Blanco or its cultivars(Fam. Rutaceae), C. unshiu Marcowicz, C. unshiu Markovich, C. reticulata 'Chachi', C. reticulata 'Dahongpao', C. reticulata 'Unshiu', C. reticulata 'Tangerina'. It is applicable to C. reticulata pericarp 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 this plant.

This document specifies the quality and safety requirements of Notopterygium incisum and Notopterygium franchetii rhizome and root(abbreviated as Notopterygium rhizome and root). This document applies to Notopterygium rhizome and 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 herb, excluding wild source herbs.

This document specifies the minimum requirements and test methods for Phellodendron bark, which is derived from the plant of Phellodendron chinense Schneid. or Phellodendron amurense Rupr. (Fam. Rutaceae). This document is applicable to Phellodendron bark 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 quality and safety requirements and test methods of Curculigo orchioides rhizome, which is derived from the root of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizome 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 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 provides a reference of single herbal medicines in order of their priority in the development of international standards.

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 the minimum requirements and test methods for Salvia miltiorrhiza root and rhizome, which is derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that is 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 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 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 minimum requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.