iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 11240:2012

(Main)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)

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 medicinal products, specifically in the context of medicinal product identification;
defines the requirements for the representation of units of measurement in coded form;
provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of ISO 11240:2012, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units.
The scope of ISO 11240:2012 is limited to the representation of units of measurement for data interchange between computer applications.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und kontrolliertes Vokabular für Maßeinheiten (ISO 11240:2012)

Diese Internationale Norm:
- legt Regeln für die Verwendung und kodierte Repräsentation von Maßeinheiten fest für den Austausch
von Informationen zu quantitativen Arzneimittelmerkmalen (z. B. Stärke) im Bereich der Humanmedizin,
bei denen die Angabe von Maßeinheiten erforderlich ist;
- stellt Anforderungen an Einheiten auf, um eine Rückführung auf internationale metrologische Normale zu
ermöglichen;
- gibt Regeln an für die genormte und maschinenlesbare Dokumentation der quantitativen Zusammensetzung
und Stärke von Arzneimitteln, vor allem im Zusammenhang mit der Arzneimittel-Identifikation;
- definiert die Anforderungen an die Repräsentation von Maßeinheiten in kodierter Form;
- stellt Strukturen und Regeln bereit, um unterschiedliche Vokabularien und Übersetzungen im
Zusammenhang mit Einheiten aufeinander abbilden zu können und so die Implementierung dieser Norm
zu unterstützen, wobei berücksichtigt wird, dass bestehende Systeme, Wörterbücher und Verzeichnisse
eine Vielzahl von Benennungen und Codes für die Darstellung von Einheiten anwenden.
Der Anwendungsbereich dieser Norm ist auf die Repräsentation von Maßeinheiten zum Datenaustausch
zwischen Rechneranwendungen begrenzt.

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les unités de mesure (ISO 11240:2012)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo merilnih enot (ISO 11240:2012)

Ta mednarodni standard: – določa pravila za uporabo in kodirano predstavitev merskih enot za izmenjavo informacij o kvantitativnih lastnostih medicinskih izdelkov, za katere so potrebne merilne enote (npr. moč) na področju zdravil za ljudi; – vzpostavlja zahteve za enote, da se zagotovi sledljivost mednarodnih meroslovnih standardov; – zagotavlja pravila za standardizirano in strojno berljivo dokumentacijo količinske sestave in moči medicinskih izdelkov, zlasti v smislu identifikacije medicinskih izdelkov; – določa zahteve za predstavitev merilnih enot v kodirani obliki; – zagotavlja strukture in pravila za preslikavanje med slovarji in jezikovnimi prevodi različnih enot za podporo uporabe tega mednarodnega standarda, pri čemer se upošteva, da se v obstoječih sistemih, slovarjih in virih uporabljajo različni izrazi in kode za predstavitev enot. Področje uporabe tega mednarodnega standarda je omejeno na predstavitev merilnih enot za izmenjavo podatkov med računalniškimi aplikacijami.

General Information

Status
Published
Publication Date
31-Oct-2012
Withdrawal Date
30-May-2013
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 1 - Information models
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Nov-2012
Due Date
05-Oct-2010
Completion Date
01-Nov-2012
Ref Project
SIST EN ISO 11240:2013 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)

Buy Standard

EN ISO 11240:2013EN ISO 11240:2013
PreviousNext
Standard
EN ISO 11240:2013
English language
56 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11240:2013
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo merilnih enot (ISO 11240:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of units of measurement (ISO 11240:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und
kontrolliertes Vokabular für Maßeinheiten (ISO 11240:2012)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les unités de
mesure (ISO 11240:2012)
Ta slovenski standard je istoveten z: EN ISO 11240:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11240:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11240:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 11240:2013


EUROPEAN STANDARD
EN ISO 11240

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for the unique identification and
exchange of units of measurement (ISO 11240:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente, Struktur und kontrolliertes Vokabular für
unique et l'échange d'informations sur les unités de mesure Maßeinheiten (ISO 11240:2012)
(ISO 11240:2012)
This European Standard was approved by CEN on 24 May 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11240:2012: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 11240:2013
EN ISO 11240:2012 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11240:2013
EN ISO 11240:2012 (E)
Foreword
This document (EN ISO 11240:2012) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 21549-7:2024(Main)
Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024)
SIST EN ISO 21549-7:2024

This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
This document specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
—     medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
—     medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
—     medication dispensed: the records of medications dispensed for the patient;
—     medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
—     physical or logical solutions for the practical functioning of particular types of data cards;
—     how the message is processed further “downstream” of the interface between two systems;
—     the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE            Not only does the definition of “medicinal products” differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
This document describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This document does not describe nor define the common objects defined within ISO 21549-2.

  • Draft
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21860:2024(Main)
Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO 21860:2020)
SIST EN ISO 21860:2024

This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4).
An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain.
An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases.
The lists do not include standards that are specifically national in scope.
The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and HIT managers. This document will also be of interest to other stakeholders such as equipment and HIT vendors, clinical and health information management (HIM) professionals and standards developers.
The intended usage of this document is to inform decisions about selecting the standards that will form the basis of integration projects in geographic regions or healthcare organizations. For example:
—     What standards to use for capturing/encoding/exchanging certain types of information
—     What standards to use for interfaces between the devices and information systems that support information capture, management, exchange, processing and use
—     What standards to use for specific use cases/deployment scenarios
The selected standards, and/or corresponding RSP clauses, might be useful when drafting project specifications.

  • Draft
    56 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 18104:2023(Main)
Health informatics - Categorial structures for representation of nursing practice in terminological systems (ISO 18104:2023)
SIST EN ISO 18104:2024

This document specifies the characteristics of categorial structures, representing nursing practice. The overall aim of this document is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes. Categorial structures for nursing diagnoses, nursing actions, nurse sensitive outcomes and associated categories support interoperability by providing common frameworks with which to
a)       analyse the features of different terminologies, including pre- and post-coordinated expressions, those of other healthcare disciplines, and to establish the nature of the relationship between them,[3][4][5][6][7][8]
b)       develop terminologies for representing nursing diagnoses, nursing actions,[9][10][11][12] and nurse sensitive outcomes,
c)        develop terminologies that are able to be related to each other,[3][8][13] and
d)       establish relationships between terminology models, information models, including archetypes, and ontologies in the nursing domain.[14][15][16][45]
There is early evidence that the categorial structures can be used as a framework for analysing nursing practice,[17] for developing nursing content of electronic record systems,[18][19] document the value of nursing services provided and to make nursing’s contribution visible[16][36][47][50].

  • Draft
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21549-5:2023(Main)
Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023)
SIST EN ISO 21549-5:2024

This document describes and defines the basic structure of the identification data objects held on healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services (although its structures can accommodate suitable data objects elsewhere specified):
—    security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
—    access control services;
—    the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this document).
Therefore, this document does not cover:
—    physical or logical solutions for the practical functioning of particular types of data card;
—    the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

  • Standard
    17 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO/IEEE 11073-10419:2023(Main)
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
SIST EN ISO/IEEE 11073-10419:2023

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

  • Standard
    135 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 17117-1:2023(Main)
Health informatics - Terminological resources - Part 1: Characteristics (ISO 17117-1:2018)
SIST EN ISO 17117-1:2023

ISO 17117-1:2018 defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It refers only to terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation.
ISO 17117-1:2018 helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. The focus of this document is to define characteristics and functions of terminological resources in healthcare that can be used to identify different types of them for categorization purposes. Clauses 4 and 5 support categorization according to the characteristics and functions of the terminological resources rather than the name.
NOTE       Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The target groups for this document are:
a)    organizations wishing to select terminological systems for use in healthcare information systems;
b)    developers of terminological systems;
c)    developers of terminology standards;
d)    those undertaking independent evaluations/academic reviews of terminological resources;
e)    terminology Registration Authorities.
ISO 17117-1:2018 contains general characteristics and criteria with which systems can be evaluated.
The following considerations are outside the scope of this document.
-      Evaluations of terminological resources.
-      Health service requirements for terminological resources and evaluation criteria based on the characteristics and functions.
-      The nature and quality of mappings between different terminologies. It is unlikely that a single terminology will meet all the terminology requirements of a healthcare organization: some terminology providers produce mappings to administrative or statistical classifications such as the International Classification of Diseases (ICD). The presence of such maps would be a consideration in the evaluation of the terminology.
-      The nature and quality of mappings between different versions of the same terminology. To support data migration and historical retrieval, terminology providers can provide maps between versions of their terminology. The presence of such maps would be a consideration in the evaluation of the terminology.
-      Terminology server requirements and techniques and tools for terminology developers.
-      Characteristics for computational biology terminology. Progress in medical science and in terminology science will necessitate updating of this document in due course.

  • Standard
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11239:2023(Main)
Health informatics - Identification of medicinal products - 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 (ISO 11239:2023)
SIST EN ISO 11239:2023

This document specifies:
—     the data elements, 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 (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 20440:2023(Main)
Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 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 (ISO/TS 20440:2023)
SIST-TS CEN ISO/TS 20440:2023

This document 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 document, 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 describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

  • Technical specification
    53 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 17251:2023(Main)
Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)
SIST-TS CEN ISO/TS 17251:2023

This document 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.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document 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 this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— 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:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

  • Technical specification
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO/IEEE 11073-10408:2022(Main)
Health informatics - Device interoperability - Part 10408: Personal health device communication - Device specialization - Thermometer (ISO/IEEE 11073-10408:2022)
SIST EN ISO/IEEE 11073-10408:2023

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth thermometer devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth thermometer devices.

  • Standard
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day