ISO 11240:2012

Overview

ISO 11240:2012 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement - defines how units of measurement should be represented, coded and exchanged between computer applications in the human medicinal product domain. As part of the IDMP (Identification of Medicinal Products) family, ISO 11240:2012 focuses on ensuring machine‑readable, standardized descriptions of quantitative medicinal product attributes (for example, strength and composition) with traceability to international metrological standards such as the SI.

Key Topics and Requirements

• Coded representation of units: Rules for representing units in coded form to enable unambiguous electronic interchange.
• Traceability to metrology: Requirements to map unit concepts to internationally recognized metrological systems (SI), supporting consistency and comparability.
• Machine‑readable documentation: Structures and data elements to capture quantitative composition and strength for medicinal product identification.
• Vocabulary and mappings: Mechanisms for mapping between different unit vocabularies, terminologies and language translations to accommodate legacy systems and local terms.
• Domain and technical models: Domain analysis, data element definitions and operational attributes to support implementation between systems.
• Normative references and annexes: Uses related standards (ISO 639, ISO 3166, ISO 11238/11239/11615, ISO 21090 and metrology guidance) and includes informative annexes with examples and mapping scenarios.

Practical Applications and Who Uses It

ISO 11240:2012 is intended for stakeholders who need reliable, interoperable exchange of quantitative medicinal product data:

• Regulatory agencies - for submission intake, validation, pharmacovigilance and lifecycle management of medicines.
• Pharmaceutical companies and sponsors - to encode product strength and composition for regulatory submissions and global data exchange.
• Health IT vendors and EHR/EMR systems - to ensure consistent unit handling when sharing medication data across systems.
• Terminology and data managers - to map local unit vocabularies to international references and preserve metrological traceability.
• Clinical trial sponsors and safety monitoring - for standardized reporting of dosages and concentrations.

Practical benefits include improved interoperability, fewer unit‑conversion errors, consistent pharmacovigilance reporting, and easier integration of international data sources.

Related Standards

ISO 11240:2012 is part of the IDMP suite and closely aligned with:

• ISO 11615, ISO 11616 (medicinal product information)
• ISO 11238 (substances)
• ISO 11239 (dose forms, presentation, routes, packaging)
• ISO 21090 (data types) and ISO/IEC Guide 99 (metrology vocabulary)

ISO 11240:2012 is limited to data interchange between computer applications and complements these standards to enable robust medicinal product identification and international regulatory interoperability.