11.120.10 - Medicaments
Medicaments
Medikamente
Médicaments
Zdravila
General Information
This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This do...view more
- Technical specification12 pagesEnglish language
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This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.
- Draft13 pagesEnglish language
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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.
- Standard19 pagesEnglish language
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This document specifies the methods for the determination of aflatoxins (AFB1, AFB2, AFG1, AFG2) in natural products using LC-FLD. It is applicable to the analysis of aflatoxins in raw materials and manufactured products, including decoction pieces derived from plants and animals.
- Standard13 pagesEnglish language
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This document specifies methods for the determination of the selected Aconitum alkaloids, including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl-yunaconitine and crassicauline A.
- Standard15 pagesEnglish language
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This document specifies the method of determination of pesticide residues in natural products used in traditional Chinese medicine (TCM) by gas chromatography (GC), including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants.
- Standard14 pagesEnglish language
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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 language
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This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicin...view more
- Standard5 pagesEnglish language
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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.
- Standard19 pagesEnglish language
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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.
- Standard13 pagesEnglish language
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This document provides a reference of single herbal medicines in order of their priority in the development of international standards.
- Technical report63 pagesEnglish language
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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.
- Standard18 pagesEnglish language
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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.
- Standard16 pagesEnglish language
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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.
- Standard14 pagesEnglish language
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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.
- Standard15 pagesEnglish language
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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.
- Standard15 pagesEnglish language
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This document gives names for crude drugs used in Kampo formulae with concepts (or definitions) that are designated by the names to ensure safety and to facilitate international trade, including source materials and intermediate products/materials. Those names are aligned with the names for both the intermediate products and the medicinal products that are manufactured in accordance with the definitions and/or designs. This document is applicable to crude drugs "as concepts (or definitions)" use...view more
- Technical report57 pagesEnglish language
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This document specifies requirements for a record of a dispense of a medicinal product.
It is intended to be adopted by detailed, implementable specifications, such as interoperability
standards, system specifications, and regulatory programs.
This document applies to information systems in which a dispense of a medicinal product is registered,
and the systems that consume such information. These systems are usually in pharmacies or other
healthcare institutions. This document does not nece...view more
- Technical specification49 pagesEnglish language
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This document specifies rules to encode formulae, and gives specific codes for 1 233 frequently-used formulae. Chinese patent medicines (CPM) are outside the scope of this document. Kampo formulae are outside of the scope of this document. This document is applicable to formula-relating databases in fields of clinical medication, scientific research and teaching, electronic medical records and prescription of traditional Chinese medicine (TCM).
- Standard290 pagesEnglish language
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ISO/TR 23022:2018 specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO 11616[10], ISO 19844[15], ISO/TS 20443[16], ISO/TS 20451[17]). ISO/TR 23022:2018 is intended to be used by: - traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo medicine; - terminologists and developers of new terminological resources concerning he...view more
- Technical report88 pagesEnglish language
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