This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

  • Standard
    11 pages
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  • Draft
    11 pages
    English language
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This document specifies requirements and test methods for laser acupoint devices. This document is not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the laser features.

  • Standard
    7 pages
    English language
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  • Draft
    7 pages
    English language
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This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

  • Standard
    22 pages
    English language
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  • Draft
    23 pages
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This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

  • Standard
    17 pages
    English language
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  • Draft
    17 pages
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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 document does not specify the detailed content of the clinical document header or other sections and entries of the clinical document body.

  • Technical specification
    12 pages
    English language
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  • Draft
    12 pages
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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.

  • Standard
    13 pages
    English language
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  • Draft
    13 pages
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This document specifies the performance criteria of peripheral visual instruments in the computerized tongue image analysis system (CTIS), including colour reproduction, distortion and resolution.

  • Technical specification
    6 pages
    English language
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  • Draft
    6 pages
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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.

  • Standard
    19 pages
    English language
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    19 pages
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This document specifies the requirements for the glass cupping device applying negative pressure created by a heat source placed in its inner cavity. This document includes the requirements for configuration, material, performance, packaging and labelling, as well as appropriate test methods. This document applies to single-use and multiple-use glass cupping devices. This document does not apply to the air extraction cupping device covered by ISO 19611.

  • Standard
    8 pages
    English language
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    8 pages
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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.

  • Standard
    13 pages
    English language
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    13 pages
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This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.

  • Standard
    51 pages
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    51 pages
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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.

  • Standard
    15 pages
    English language
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    16 pages
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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.

  • Standard
    14 pages
    English language
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  • Draft
    14 pages
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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 specification
    10 pages
    English language
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  • Draft
    10 pages
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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 medicinal materials.

  • Standard
    5 pages
    English language
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    5 pages
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This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.

  • Standard
    5 pages
    English language
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  • Draft
    5 pages
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This document specifies the safety requirements for the thread-embedding acupuncture needle. It is applicable to only the needle part of thread-embedding acupuncture needles and excludes medical thread.

  • Standard
    10 pages
    English language
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  • Standard
    10 pages
    English language
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This document specifies the colour character and appearance of the colour chart used in a computerized tongue image analysis system (CTIS). This document excludes diagnostic or clinical comparison to the colour chart.

  • Technical specification
    9 pages
    English language
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This document defines terms for the theory, technology and methods of Chinese Materia Medica processing. It is not applicable to Kampo medicine.

  • Standard
    24 pages
    English language
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This document specifies the application, in the context of traditional Chinese medicine practice, of medical waveform format encoding rules (MFER) to pulse condition waveform as measured in physiological laboratories, hospitals, bed-wards, pharmacies, clinics, community health centres and home care check-ups using pulse condition devices.

  • Standard
    14 pages
    English language
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This document specifies an information model within the field of Chinese materia medica processing. It defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable information model. This model aims at representing the concepts applicable to Chinese materia medica processing in the making of decoction pieces. This document is not applicable to Japanese traditional Kampo medicine.

  • Technical specification
    11 pages
    English 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.

  • Standard
    19 pages
    English language
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This document specifies the whole manufacturing process of Chinese materia medica products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable categorial structure. It includes three process categories: processing, extracting and preparation. This document is not applicable to Japanese traditional KAMPO medicinal products.

  • Technical specification
    8 pages
    English language
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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.

  • Standard
    13 pages
    English 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.

  • Standard
    13 pages
    English language
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This document aims to specify categorial structures in the field of decoction. This document describes a concept system detailing domain constraints of sanctioned characteristics, each composed of a semantic link and applicable characterizing categories. The following topics are out of scope of this document: — models of decoction pieces; — the specification of categorial structures for the representation of post or manufacturing processes of decoction such as packaging; — individual pharmaceutical, medicinal products or herbal substances. This document is applicable to terminological systems/resources.

  • Technical specification
    6 pages
    English 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 report
    63 pages
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This document defines the classification rules and coding scheme for traditional Chinese medicine (TCM) data sets. It is applicable for investigation and management of TCM data resources as well as the description, integration, publication, index and retrieval of the TCM data sets. This document excludes the Kampo medicine .

  • Technical specification
    14 pages
    English language
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This document specifies the requirements and test methods for therapeutic fumigation devices, hereafter referred to as the device. This document does not apply to decoction pieces.

  • Standard
    8 pages
    English language
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This document establishes the core classification framework for the integration of clinical terms from traditional Chinese medicine (TCM) and Western medicine. This structure supports terminology integration in standardized electronic medical records, including professional clinical terms in TCM and Western medicine. Non-technical terms for electronic medical records are also included.

  • Technical specification
    8 pages
    English language
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This document specifies a test method for characterizing the corrosion resistance of single-use acupuncture needles intended for use in electro-acupuncture treatment. This document is applicable only to testing of acupuncture needles that conform with ISO 17218. This document does not specify pass/fail criteria. Also, it is not intended to provide safety information for real clinical practice.

  • Standard
    10 pages
    English language
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This document specifies general requirements to ensure 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.

  • Standard
    14 pages
    English 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.

  • Standard
    18 pages
    English language
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This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.

  • Standard
    11 pages
    English language
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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.

  • Standard
    9 pages
    English language
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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.

  • Standard
    18 pages
    English 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.

  • Standard
    16 pages
    English language
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This document specifies the general requirements for basic performance and safety of abdominal physiological parameter detectors. It covers the material, basic parameters and testing method of abdominal parameter detectors but does not prescribe the clinical abdominal diagnosis associated with the findings obtained from the devices.

  • Technical specification
    6 pages
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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.

  • Standard
    14 pages
    English 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.

  • Standard
    15 pages
    English language
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This document describes a method of acquisition of tongue image and expression of tongue colour and coating colour by computerized tongue image analysis system (CTIS). This document does not cover the clinical tongue diagnosis result.

  • Technical report
    16 pages
    English 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.

  • Standard
    15 pages
    English language
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This document specifies the information model within the subject field of combination of Chinese medicines. A set of domain constraints of sanctioned characteristics have been defined in the model. Domain constraints are achieved through a set of relationships. This document does not apply to Kampo medicine.

  • Technical specification
    6 pages
    English language
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This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

  • Standard
    8 pages
    English 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)" used in Kampo medicine. This document excludes the following: — individual manufactured drug names for medicinal products "as things" derived from crude drugs; — medicinal materials (Materia Medica) "as things", or traditional medicines that are not regulated by the Japanese Pharmacopoeia or the related official documents published by the Medicinal Regulatory Agency, the Ministry of Health Labour and Welfare of Japan.

  • Technical report
    57 pages
    English 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).

  • Standard
    290 pages
    English 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 herbal medicines in Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo medicine to enable their conformance; - informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine; - officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of national health policies; - officers of WHO, and WHO statistics. This edition of ISO/TR 23022:2018 describes only medicinal products in accordance with the Kampo formula in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products are omitted, although they are permitted under Japanese jurisdiction. Topics considered out of scope of this document are: - any medicinal products manufactured in accordance with the formula of traditional medicines that are not permitted under the Japanese jurisdiction; - whole information models of medicinal products, pharmaceutical products and substances (see ISO 11238) because those are already specified in IMDPs; - any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115[13] and EN 12264[18]). The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.

  • Technical report
    88 pages
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ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices. ISO 20495:2018 is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. ISO 20495:2018 is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

  • Standard
    9 pages
    English language
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ISO 19617:2018 specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM. ISO 19617:2018 does not conflict with general pharmaceutical good manufacturing practices (GMPs). ISO 19617:2018 applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.

  • Standard
    18 pages
    English language
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ISO/TR 20520:2018 specifies aspects to be considered for infection control for acupuncture treatment. Clinical practice in acupuncture treatment is outside the scope of this document.

  • Technical report
    5 pages
    English language
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