This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

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    • Technical specification
      36 pages
      English language
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    • Draft
      36 pages
      English language

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base...view more

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    • Technical specification
      31 pages
      English language
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    • Draft
      31 pages
      English language

The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.

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    • Technical report
      9 pages
      English language

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

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    • Standard
      61 pages
      English language
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    • Standard
      65 pages
      French language

This document 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 infor...view more

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    • Technical specification
      887 pages
      English language

ISO/TS 19293:2018 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. ISO/TS 19293:2018 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 n...view more

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    • Technical specification
      38 pages
      English language

ISO 11616:2017 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 ad...view more

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    • Standard
      33 pages
      English language
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    • Standard
      35 pages
      French language

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017. Reference to ISO 11238, ISO 112...view more

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    • Technical specification
      48 pages
      English language

ISO 11615:2017 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 appl...view more

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    • Standard
      79 pages
      English language
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    • Standard
      85 pages
      French language

ISO/TS 20443:2017 defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to suppo...view more

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    • Technical specification
      202 pages
      English language

The purpose of ISO/TR 20831:2017 is to define the various concepts and terminologies used in the pharmacy domain when applied to the topic of creating medication lists from existing data.

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    • Technical report
      19 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 considerat...view more

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    • Technical specification
      9 pages
      English language
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    • Technical specification
      9 pages
      English language

ISO/TS 20440:2016 describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. Based on the principles outlined in this Technical Specification, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to descri...view more

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    • Technical specification
      43 pages
      English language
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    • Technical specification
      43 pages
      English language

ISO 17523:2016 specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions. ISO 17523:2016 is constrained to the content of the electronic prescription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the...view more

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    • Standard
      18 pages
      English language
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    • Standard
      18 pages
      English language
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    • Standard
      19 pages
      French language
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    • Standard
      19 pages
      French language

ISO/TS 19256:2016 defines the required characteristics for any MPD-system to support use cases in healthcare. These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.

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    • Technical specification
      36 pages
      English language
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    • Technical specification
      36 pages
      English language

ISO 11239:2012 specifies: · the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products; · a mechanism for the association of translations of a single concept into different languages; · a mechanism for the versioning of the concepts in order to track their evolution; · rules to allow regio...view more

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    • Standard
      28 pages
      English language
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    • Standard
      29 pages
      French language

ISO 11240:2012: specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; establishes requirements for units in order to provide traceability to international metrological standards; provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medici...view more

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    • Standard
      48 pages
      English language
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    • Standard
      50 pages
      French language

ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.

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    • Standard
      585 pages
      English language
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    • Standard
      585 pages
      French language

ISO 27953-1:2011 seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that can occur upon the administration or use of one or more products. The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. IS...view more

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    • Standard
      597 pages
      English language
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    • Standard
      597 pages
      French 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 i...view more

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    • Technical specification
      623 pages
      English language

ISO/TS 19844:2015 is used in the implementation of ISO 11238. ISO/TS 19844:2015 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 ...view more

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    • Technical specification
      260 pages
      English language

ISO/TS 16791:2014 provides guidance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. ISO/TS 16791:2014 outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).

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    • Technical specification
      23 pages
      English language

ISO 11616:2012 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 ad...view more

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    • Standard
      40 pages
      English language
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    • Standard
      41 pages
      French language

ISO 11615:2012 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.

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    • Standard
      114 pages
      English language
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    • Standard
      117 pages
      French language

ISO/TS 22224:2009 encompasses the electronic reporting of adverse reactions caused by drugs for human uses. Thus, other businesses relating to adverse events caused by blood transfusion, medical devices and veterinary drugs are excluded from the scope of ISO/TS 22224:2009.

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    • Technical specification
      11 pages
      English language

ISO/TR 22790:2007 provides a common conceptual model of information management related to the process of prescribing or ordering medication. This Technical Report provides a set of optional business requirements that could be selected by the buyer in a procurement process to be responded to by a tendering supplier. This report shall not provide any mandatory requirements but, as an informative document, give a common expression of various possible functions meeting different objectives for the h...view more

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    • Technical report
      19 pages
      English language