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

  • Standard
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    11 pages
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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
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    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
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    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.

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    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.

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    13 pages
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    13 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.

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    19 pages
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    19 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.

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    13 pages
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    13 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.

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    15 pages
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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.

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    14 pages
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    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.

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    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.

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    5 pages
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    5 pages
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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.

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    19 pages
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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.

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    13 pages
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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 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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    18 pages
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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.

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    16 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.

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    14 pages
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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.

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    15 pages
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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.

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    15 pages
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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
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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 necessarily apply to non-pharmacy shops or other nonclinical
systems (e.g. supermarket cashiers).
The scope of this document includes the activities relating to the dispensing of a medicinal product and
the information content for the capture of structured information produced in those events.
These activities include any actual dispense, cancellation or other outcome that may have occurred at
the time of planned or actual dispense. In other words, the dispense record also contains information
that medication was expected to be dispensed but was not dispensed.

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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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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.

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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.

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    18 pages
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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 applicable.
Furthermore, to support successful information exchange in relation to the unique identification
and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is
included, which are to be applied in the context of this document.

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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
addition, this document is essential to ensure that pharmaceutical product information is assembled
in a structured format with transmission between a diverse set of stakeholders for both regulatory
and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and
compatibility for both the sender and the recipient.
This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is
a formal association of particular data elements categorised in prescribed combinations and uniquely
identified when levelling degrees of information are incomplete. This allows for Medicinal Products to
be unequivocally identified on a global level.
References to other normative IDMP and messaging standards for pharmaceutical product information
are included in Clause 2, to be applied in the context of this document.
Medicinal products for veterinary use are out of scope of this document.

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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 various regions and countries is given in Annex A.

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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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    15 pages
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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 information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances.
This second edition of the document addresses substances, Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G and H. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may be essential to distinguishing substances. This document addresses the following:
· Data elements necessary for defining Substances and Specified Substances Groups 1 to 3;
· The logical use of data elements as defined in ISO 11238;
· Substances and Specified Substances Groups 1 to 3 business rules for
- determining necessary data elements,
- distinguishing and defining materials according to ISO 11238,
- triggering the assignment of identifiers.
ISO/TS 19844:2016 does not address the following:
· Business processes for data management;
· Implementation of a specific data information system (e.g. a relational database schema);
· Normative messaging standards for substances;
· The maintenance of controlled vocabularies;
· The specific global identifier system that should be used;
· Nomenclature standards for substances.

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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 requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

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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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    9 pages
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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.

  • Standard
    17 pages
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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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    10 pages
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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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    76 pages
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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.

  • Standard
    81 pages
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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.

  • Standard
    55 pages
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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 consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope.
It does not define an information model, except to the extent that those information model concepts are necessary to define business requirements.
Outside the scope of ISO/TS 17251:2016 are:
- the functionality of health, clinical and/or pharmacy systems;
- other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of health care providers, such as:
- wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems;
- the complete medical record (EHR);
- a medicinal product dictionary.

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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 granule forms of individual medicinals for prescriptions (GFIMP) in the fields of clinical medication, scientific research and teaching, and statistics and management.

  • Standard
    23 pages
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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.

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

  • Technical report
    11 pages
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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.

  • Standard
    75 pages
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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 for certification purposes.

  • Standard
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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 medicinal products or, where there is no outer packaging, on the immediate packaging shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with".
The principles in this European Standard can be applied in other countries and sectors, as appropriate.

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