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.

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    • Standard
      17 pages
      English language
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    • Draft
      17 pages
      English language

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.

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    • Standard
      22 pages
      English language
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    • Draft
      23 pages
      English language

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

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

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.

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    • Standard
      13 pages
      English language
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    • Draft
      13 pages
      English language

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.

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    • Standard
      19 pages
      English language
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    • Draft
      19 pages
      English language

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.

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    • Standard
      13 pages
      English language
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    • Draft
      13 pages
      English language

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.

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    • Standard
      15 pages
      English language
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    • Draft
      16 pages
      English language

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.

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    • Standard
      14 pages
      English language
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    • Draft
      14 pages
      English language

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.

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    • Technical specification
      10 pages
      English language
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    • Draft
      10 pages
      English language

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

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    • Standard
      5 pages
      English language
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    • Draft
      5 pages
      English language

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.

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    • Standard
      19 pages
      English language

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.

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    • Standard
      13 pages
      English language

This document provides a reference of single herbal medicines in order of their priority in the development of international standards.

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    • Technical report
      63 pages
      English language

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.

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    • Standard
      18 pages
      English language

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.

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    • Standard
      16 pages
      English language

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.

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    • Standard
      14 pages
      English language

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.

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    • Standard
      15 pages
      English language

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.

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    • Standard
      15 pages
      English language

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

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    • Technical report
      57 pages
      English language

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...
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    • Technical specification
      49 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).

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    • Standard
      290 pages
      English language

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

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    • Technical report
      88 pages
      English language

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 n...view more

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    • Standard
      18 pages
      English language

This document establishes definitions and concepts and describes data elements and their structural
relationships, which are required for the unique identification and the detailed description of Medicinal
Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify
regulated Medicinal Products for human use during their entire life cycle, i.e. from development to
authorisation, post-marketing and renewal or withdrawal from the market, where ...
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    • Standard
      90 pages
      English language
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This document is intended to provide specific levels of information relevant to the identification
of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and
relationships between data elements that are required for the exchange of regulated information, in
order to uniquely identify pharmaceutical products. This identification is to be applied throughout
the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In...
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    • Standard
      43 pages
      English language
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ISO 21371:2018 specifies general requirements for the labelling of products intended for oral or topical use in and as traditional Chinese medicine (TCM). ISO 21371:2018 is applicable to all finished manufactured products including packaged herbs used in and as TCM. This document includes the essential and informative elements for labelling of products to assist in the choice and safe use of these products by consumers and practitioners. NOTE A list of TCM labelling requirements of the WHO and v...view more

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    • Standard
      6 pages
      English language

ISO 20759:2017 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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    • Standard
      15 pages
      English language

ISO/TS 19844:2016 is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.
ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of ...
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    • Technical specification
      635 pages
      English language
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ISO 15378:2017 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the ...
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    • Standard
      93 pages
      English language
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ISO 20333:2017 specifies coding rules for Chinese medicines to assist in supply chain management. The coding provides information such as the trade item, producing area, unit, grade, production date, batch number, quantity of medicines, and logistic unit. This includes Chinese Materia Medica and decoction pieces, but excludes granule forms of individual medicinals for prescriptions (GFIMP) and Chinese patent medicines (CPM).

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    • Standard
      9 pages
      English language

ISO 20409:2017are derived from the plant Panax notoginseng (Burk.) F.H. Chen. It is applicable to notoginseng root and rhizome that are sold and used as food supplements, functional food or natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

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    • Standard
      17 pages
      English language

This document specifies the general requirements for the industrial manufacturing process of red ginseng from Panax ginseng C.A. Meyer which is the only species from which red ginseng is processed[6-11]. It is intended that manufacturers perform the appropriate washing, steaming, drying and packaging processes to assure the quality of red ginseng products for consumers.

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    • Standard
      10 pages
      English language

ISO 18668-2:2017 encodes 828 kinds of decoction pieces, according to the rules in ISO 18668-1. This document is suitable for coding of decoction pieces, as well as decoction pieces in the fields of clinical medication, scientific research, teaching, statistics, and management.

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    • Standard
      76 pages
      English language

ISO 18668-4:2017 encodes 777 kinds of granule forms of individual medicinals for prescriptions, according to the rules in ISO 18668‑1. ISO 18668-4:2017 is suitable for coding of granule forms of individual medicinals for prescriptions, as well as granule forms of individual medicinals for prescriptions in the fields of clinical medication, scientific research, teaching, statistics and management.

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    • Standard
      81 pages
      English language

ISO 18668-3:2017 encodes 592 kinds of Chinese Materia Medica, according to the rules in ISO 18668‑1. ISO 18668-3:2017 is suitable for coding of Chinese Materia Medica, as well as Chinese Materia Medica in the fields of clinical medication, scientific research, teaching, statistics and management.

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    • Standard
      55 pages
      English language

ISO/TS 17251:2016 specifies the business requirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable to primary, secondary and tertiary care.
NOTE See 2.9, note to entry, regarding the use of "medication order" and "prescription".
Comprehension of dose instructions by the patient is an overarching consider...
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    • Technical specification
      17 pages
      English language
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ISO 18668-1:2016 specifies rules to encode Chinese medicines, including decoction pieces, Chinese Materia Medica (raw materials) and granule forms of individual medicinals for prescriptions (GFIMP), but not Chinese patent medicines (CPM). Relevant coding standards for Kampo medicine, Korean medicine and other traditional medicines will be separately formulated as needed by experts in these areas. ISO 18668-1:2016 is suitable for decoction pieces, Chinese Materia Medica (raw materials), and granu...view more

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    • Standard
      23 pages
      English language

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 ...view more

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    • Standard
      8 pages
      English language

This European Technical Report addresses the provision of information for medicinal products in alternative formats suitable for blind and partially sighted people.

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    • Technical report
      11 pages
      English language
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      1 day

ISO 15378:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

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    • Standard
      75 pages
      English language
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      1 day

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable f...
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    • Standard
      80 pages
      English language
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This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
NOTE   The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. Article 54(o) of the Directive stipulates, that on the outer packaging of certain medicina...
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    • Standard
      18 pages
      English language
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      1 day