iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

CEN ISO/TS 19844:2015

(Main)

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

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 of information for substances. ISO/TS 19844:2015 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 first edition of ISO/TS 19844:2015 will only address substances, and Groups 1 to 3 of the specified substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of ISO/TS 19844:2015. Some information that would typically fall under specified substances Group 4 may be covered in the Annexes of ISO/TS 19844:2015. This information, although not defining of either a substance or a specified substance Group 1, may be essential to distinguishing substances.
ISO/TS 19844:2015 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.

Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden für EN ISO 11238, Struktur und kontrollierten Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen (ISO/TS 19844:2015)

Informatique de santé - Identification des médicaments - Lignes directrices pour la mise en oeuvre des éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances (ISO/TS 19844:2015)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO/TS 19844:2015)

Ta tehnična specifikacija se uporablja v okviru uvajanja standarda ISO 11238. Ta tehnična specifikacija določa substance na podlagi njihove znanstvene identitete (tj. to, kar so) namesto njihove uporabe ali načina izdelave. ISO 11238 ponuja konceptualni okvir za določanje substanc in specificiranih substanc ter za dodeljevanje enoličnih identifikatorjev v kontekstu standardov ISO IDMP. ISO 11238 opisuje splošne koncepte za določanje in razlikovanje substanc ter model za strukturiranje informacij za substance na visoki ravni. Ta tehnična specifikacija podaja podrobne razlage informacij o posameznih vrstah ali skupinah substanc, opise na ravni posameznih elementov za uvajanje standarda ISO 11238 ter primere za številne substance in specificirane substance.
Prva izdaja te tehnične specifikacije obravnava samo substance in skupine 1–3 specificiranih substanc, kot je določeno v standardu ISO 11238 ter dodatkih A, B, C in D. Specificirane substance skupine 4 bodo po pričakovanjih obravnavane v naslednji izdaji te tehnične specifikacije, kot je določeno v standardu ISO 11238. Nekatere informacije, ki bi običajno sodile v okvir specificiranih substanc skupine 4, so morda obravnavane v dodatkih te tehnične specifikacije. Te informacije so lahko bistvene za razlikovanje substanc, čeprav ne določajo substance ali specificirane substance skupine 1.
Ta tehnična specifikacija obravnava:
• podatkovne elemente, potrebne za določitev substanc in specificiranih substanc skupin 1–3;
• logično uporabo podatkovnih elementov, kot je določeno v standardu ISO 11238;
• poslovna pravila za substance in specificirane substance skupin 1–3 glede:
– določanja potrebnih podatkovnih elementov,
– razlikovanja in določanja materialov v skladu s standardom ISO 11238,
– sprožanja dodelitve identifikatorjev.
Ta tehnična specifikacija ne obravnava:
• poslovnih procesov za upravljanje podatkov;
• uvedbe posebnega informacijskega sistema za obdelavo podatkov, kot je na primer relacijska zbirka podatkov;
• normativnih standardov o sporočanju za substance;
• vzdrževanja nadzorovanih slovarjev;
• posebnega globalnega sistema identifikatorjev;
• nomenklaturni standardi za substance.

General Information

Status
Withdrawn
Publication Date
22-Dec-2015
Withdrawal Date
29-Aug-2017
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
9960 - Withdrawal effective - Withdrawal
Completion Date
30-Aug-2017
Ref Project
SIST-TS CEN ISO/TS 19844:2016 - Health informatics - Identification of medicinal products - Implementation guide for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

Relations

Replaced By
CEN ISO/TS 19844:2017 - Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016)
Effective Date
06-Sep-2017

Buy Standard

TS CEN ISO/TS 19844:2016TS CEN ISO/TS 19844:2016
PreviousNext
Technical specification
TS CEN ISO/TS 19844:2016
English language
272 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 19844:2016
01-april-2016
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo
podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo
predpisanih informacij o substancah (ISO/TS 19844:2015)
Health informatics - Identification of medicinal products - Implementation guide for data
elements and structures for the unique identification and exchange of regulated
information on substances (ISO/TS 19844:2015)
Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden für die
Struktur und kontrollierten Vokabularien zur Identifikation und Beschreibung von
Substanzen und Inhaltsstoffen (ISO/TS 19844:2015)
Informatique de santé - Identification des médicaments - Guide pour la mise en oeuvre
des éléments de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les substances (ISO/TS 19844:2015)
Ta slovenski standard je istoveten z: CEN ISO/TS 19844:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 19844:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST-TS CEN ISO/TS 19844:2016

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

SIST-TS CEN ISO/TS 19844:2016


CEN ISO/TS 19844
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

December 2015
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version

Health informatics - Identification of medicinal products -
Implementation guidelines for data elements and
structures for the unique identification and exchange of
regulated information on substances (ISO/TS 19844:2015)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour la mise en oeuvre des Arzneimitteln - Anwendungsleitfaden für die Struktur
éléments de données et structures pour l'identification und kontrollierten Vokabularien zur Identifikation und
unique et l'échange d'informations réglementées sur Beschreibung von Substanzen und Inhaltsstoffen
les substances (ISO/TS 19844:2015) (ISO/TS 19844:2015)
This Technical Specification (CEN/TS) was approved by CEN on 4 April 2016 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19844:2015 E
worldwide for CEN national Members.

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

SIST-TS CEN ISO/TS 19844:2016
CEN ISO/TS 19844:2015 (E)
Contents Page
European foreword . 3

2

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

SIST-TS CEN ISO/TS 19844:2016
CEN ISO/TS 19844:2015 (E)
European foreword
This document (CEN ISO/TS 19844:2015) 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.
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 organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Ital
...

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 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 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 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