About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
CEN/TC 251 |
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Health informatics |
CEN/TC 251 Published Standards
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CEN ISO/TS 14265:2024
(WI=00251371) Health informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2024) |
2024-01-17 |
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CEN ISO/TS 14441:2013
(WI=00251267) Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013) |
2013-12-18 |
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CEN ISO/TS 16791:2020
(WI=00251344) Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020) |
2020-10-14 |
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CEN ISO/TS 17251:2023
(WI=00251358) Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023) |
2023-03-15 |
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CEN ISO/TS 19256:2017
(WI=00251296) Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) |
2017-03-22 |
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CEN ISO/TS 19293:2018
(WI=00251297) Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018) |
2018-05-09 |
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CEN ISO/TS 19844:2017
(WI=00251326) 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) |
2017-08-30 |
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CEN ISO/TS 20440:2023
(WI=00251364) 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) |
2023-04-12 |
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CEN ISO/TS 20443:2018
(WI=00251318) Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) |
2018-05-16 |
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CEN ISO/TS 20451:2018
(WI=00251319) Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017) |
2018-05-16 |
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CEN ISO/TS 22703:2021
(WI=00251342) Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021) |
2021-10-20 |
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CEN ISO/TS 22756:2020
(WI=00251341) Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020) |
2020-09-30 |
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CEN ISO/TS 5499:2024
(WI=00251367) Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024) |
2024-02-07 |
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CEN ISO/TS 82304-2:2021
(WI=00251339) Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021) |
2021-08-11 |
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CEN/TR 15212:2006
(WI=00251079) Health informatics - Vocabulary - Maintenance procedure for a web-based terms and concepts database |
2006-10-11 |
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CEN/TR 15253:2005
(WI=00251122) Health informatics - Quality of service requirements for health information interchange |
2005-12-07 |
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CEN/TR 15299:2006
(WI=00251096) Health informatics - Safety procedures for identification of patients and related objects |
2006-09-06 |
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CEN/TR 15300:2006
(WI=00251124) Health informatics - Framework for formal modelling of healthcare security policies |
2006-10-11 |
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CEN/TR 15872:2014
(WI=00251223) Health informatics - Guidance on patient identification and cross-referencing of identities |
2014-03-12 |
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CEN/TS 14822-4:2005
(WI=00251169) Health informatics - General purpose information components - Part 4: Message headers |
2005-06-29 |
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CEN/TS 17288:2020
(WI=00251338) Health informatics - The International Patient Summary - Guideline for European Implementation |
2020-05-27 |
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EN 1064:2020
(WI=00251335) Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
2020-08-12 |
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EN 1068:2005
(WI=00251149) Health informatics - Registration of coding systems |
2005-06-15 |
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EN 12251:2004
(WI=00251182) Health informatics - Secure User Identification for Health Care - Management and Security of Authentication by Passwords |
2004-08-18 |
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EN 12264:2005
(WI=00251146) Health informatics - Categorial structures for systems of concepts |
2005-06-15 |
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EN 12435:2006
(WI=00251108) Health informatics - Expression of results of measurements in health sciences |
2006-01-25 |
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EN 13609-1:2005
(WI=00251127) Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 1: Updating of coding schemes |
2005-05-11 |
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EN 14484:2003
(WI=00251150) Health informatics - International transfer of personal health data covered by the EU data protection directive - High level security policy |
2003-12-17 |
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EN 14485:2003
(WI=00251157) Health informatics - Guidance for handling personal health data in international applications in the context of the EU data protection directive |
2003-12-17 |
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EN 14822-1:2005
(WI=00251165) Health informatics - General purpose information components - Part 1: Overview |
2005-10-19 |
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EN 14822-2:2005
(WI=00251166) Health informatics - General purpose information components - Part 2: Non-clinical |
2005-10-19 |
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EN 14822-3:2005
(WI=00251167) Health informatics - General purpose information components - Part 3: Clinical |
2005-10-19 |
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EN 1614:2006
(WI=00251099) Health informatics - Representation of dedicated kinds of property in laboratory medicine |
2006-09-27 |
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EN ISO 10781:2015
(WI=00251271) Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015) |
2015-08-12 |
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EN ISO 11073-00103:2017
(WI=00251314) Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
2017-02-15 |
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EN ISO 11073-10101:2020
(WI=00251349) Health informatics - Device interoperability - Part 10101: Point-of-care medical device communication - Nomenclature (ISO/IEEE 11073-10101:2020) |
2020-09-23 |
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EN ISO 11073-10102:2014
(WI=00251292) Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014) |
2014-03-05 |
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EN ISO 11073-10103:2013
(WI=00251293) Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014, Corrected version 2014-05-01) |
2013-12-18 |
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EN ISO 11073-10406:2012
(WI=00251273) Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
2012-12-01 |
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EN ISO 11073-10417:2017
(WI=00251328) Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2017) |
2017-05-17 |
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EN ISO 11073-10418:2014
(WI=00251274) Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor (ISO/IEEE 11073-10418:2014, Corrected version 2014-05-01) |
2014-03-05 |
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EN ISO 11073-10418:2014/AC:2016
(WI=00251C01) Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016) |
2016-10-19 |
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EN ISO 11073-10421:2012
(WI=00251270) Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012) |
2012-11-01 |
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EN ISO 11073-10424:2016
(WI=00251312) Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) (ISO/IEEE 11073-10424:2016) |
2016-06-29 |
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EN ISO 11073-10424:2016/AC:2018
(WI=00251C02) Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) - Technical Corrigendum 1 (ISO/IEEE 11073-10424:2016/Cor 1:2018) |
2018-01-24 |
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EN ISO 11073-10425:2019
(WI=00251346) Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019) |
2019-04-17 |
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EN ISO 11073-10427:2018
(WI=00251336) Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018) |
2018-03-14 |
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EN ISO 11073-10441:2017
(WI=00251311) Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015) |
2017-02-15 |
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EN ISO 11073-10442:2017
(WI=00251315) Health informatics - Personal health device communication - Part 10442: Device specialization - Strength fitness equipment (ISO/IEEE 11073-10442:2015, Corrected version 2017-11-01) |
2017-02-15 |
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EN ISO 11073-10471:2011
(WI=00251245) Health Informatics - Personal health device communication - Part 10471: Device specialization - Independant living activity hub (ISO/IEEE 11073-10471:2010) |
2011-03-16 |
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EN ISO 11073-10472:2012
(WI=00251246) Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012) |
2012-11-01 |
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EN ISO 11073-20101:2005
(WI=00251161) Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004) |
2005-08-31 |
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EN ISO 11073-20701:2020
(WI=00251354) Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service oriented medical device exchange architecture and protocol binding (ISO/IEEE 11073-20701:2020) |
2020-04-01 |
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EN ISO 11073-30200:2005
(WI=00251180) Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected (ISO/IEEE 11073-30200:2004) |
2005-08-31 |
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EN ISO 11073-30200:2005/A1:2015
(WI=00251298) Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected - Amendment 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015) |
2015-09-23 |
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EN ISO 11073-30300:2005
(WI=00251164) Health informatics - Point-of-care medical device communication - Part 30300: Transport profile - Infrared wireless (ISO/IEEE 11073-30300:2004) |
2005-08-31 |
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EN ISO 11073-30400:2012
(WI=00251268) Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012) |
2012-11-01 |
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EN ISO 11238:2018
(WI=00251323) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018) |
2018-08-01 |
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EN ISO 11239:2023
(WI=00251363) 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) |
2023-06-14 |
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EN ISO 11240:2012
(WI=00251229) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) |
2012-11-01 |
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EN ISO 11615:2017
(WI=00251322) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017) |
2017-12-06 |
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EN ISO 11615:2017/A1:2022
(WI=00251365) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022) |
2022-09-21 |
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EN ISO 11616:2017
(WI=00251327) Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017) |
2017-12-06 |
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EN ISO 12052:2017
(WI=00251334) Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017) |
2017-09-13 |
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EN ISO 12381:2019
(WI=00251340) Health informatics - Explicit time-related expressions for healthcare-specific problems (ISO 12381:2019) |
2019-09-11 |
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EN ISO 12967-1:2020
(WI=00251329) Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO 12967-1:2020) |
2020-11-18 |
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EN ISO 12967-2:2020
(WI=00251330) Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO 12967-2:2020) |
2020-11-18 |
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EN ISO 12967-3:2020
(WI=00251331) Health informatics - Service Architecture (HISA) - Part 3: Computational viewpoint (ISO 12967-3:2020) |
2020-11-18 |
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EN ISO 13119:2022
(WI=00251351) Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2022) |
2022-11-02 |
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EN ISO 13120:2019
(WI=00251321) Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019) |
2019-05-29 |
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EN ISO 13131:2022
(WI=00251387) Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021) |
2022-11-16 |
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EN ISO 13606-1:2019
(WI=00251307) Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019) |
2019-07-03 |
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EN ISO 13606-2:2019
(WI=00251280) Health informatics - Electronic health record communication - Part 2: Archetype interchange specification (ISO 13606-2:2019) |
2019-07-03 |
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EN ISO 13606-3:2019
(WI=00251282) Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists (ISO 13606-3:2019) |
2019-07-03 |
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EN ISO 13606-4:2019
(WI=00251281) Health informatics - Electronic health record communication - Part 4: Security (ISO 13606-4:2019) |
2019-07-03 |
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EN ISO 13606-5:2019
(WI=00251289) Health informatics - Electronic health record communication - Part 5: Interface specification (ISO 13606-5:2019) |
2019-07-03 |
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EN ISO 13940:2016
(WI=00251261) Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
2016-01-27 |
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EN ISO 13972:2022
(WI=00251356) Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022) |
2022-03-09 |
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EN ISO 16278:2016
(WI=00251295) Health informatics - Categorial structure for terminological systems of human anatomy (ISO 16278:2016) |
2016-03-23 |
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EN ISO 17117-1:2023
(WI=00251357) Health informatics - Terminological resources - Part 1: Characteristics (ISO 17117-1:2018) |
2023-07-19 |
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EN ISO 17523:2016
(WI=00251303) Health informatics - Requirements for electronic prescriptions (ISO 17523:2016) |
2016-06-29 |
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EN ISO 18104:2023
(WI=00251362) Health informatics - Categorial structures for representation of nursing practice in terminological systems (ISO 18104:2023) |
2023-12-13 |
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EN ISO 1828:2012
(WI=00251232) Health informatics - Categorial structure for terminological systems of surgical procedures (ISO 1828:2012) |
2012-09-15 |
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EN ISO 18530:2021
(WI=00251348) Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021) |
2021-02-10 |
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EN ISO 18812:2003
(WI=00251138) Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003) |
2003-03-15 |
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EN ISO 21090:2011
(WI=00251221) Health Informatics - Harmonized data types for information interchange (ISO 21090:2011) |
2011-02-15 |
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EN ISO 21091:2013
(WI=00251234) Health informatics - Directory services for healthcare providers, subjects of care and other entities (ISO 21091:2013) |
2013-02-27 |
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EN ISO 21298:2017
(WI=00251306) Health informatics - Functional and structural roles (ISO 21298:2017, Corrected version 2017-04) |
2017-02-22 |
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EN ISO 21393:2021
(WI=00251353) Genomics informatics - Omics Markup Language (OML) (ISO 21393:2021) |
2021-08-11 |
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EN ISO 21549-1:2013
(WI=00251263) Health informatics - Patient healthcard data - Part 1: General structure (ISO 21549-1:2013) |
2013-06-19 |
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EN ISO 21549-2:2014
(WI=00251275) Health informatics - Patient healthcard data - Part 2: Common objects (ISO 21549-2:2014) |
2014-02-19 |
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EN ISO 21549-3:2014
(WI=00251276) Health informatics - Patient healthcard data -- Part 3: Limited clinical data (ISO 21549-3:2014) |
2014-02-19 |
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EN ISO 21549-4:2014
(WI=00251277) Health informatics - Patient healthcard data - Part 4: Extended clinical data (ISO 21549-4:2014) |
2014-02-19 |
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EN ISO 21549-5:2023
(WI=00251372) Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023) |
2023-11-08 |
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EN ISO 21549-6:2008
(WI=00251203) Health informatics - Patient healthcard data - Part 6: Administrative data (ISO 21549-6:2008) |
2008-04-15 |
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EN ISO 21549-7:2024
(WI=00251392) Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024) |
2024-02-21 |
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EN ISO 21549-8:2010
(WI=00251177) Health informatics - Patient healthcard data - Part 8: Links (ISO 21549-8:2010) |
2010-06-15 |
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EN ISO 21860:2024
(WI=00251398) Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO 21860:2020) |
2024-02-21 |
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EN ISO 22600-1:2014
(WI=00251287) Health informatics - Privilege management and access control - Part 1: Overview and policy management (ISO 22600-1:2014) |
2014-10-15 |
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EN ISO 22600-2:2014
(WI=00251288) Health informatics - Privilege management and access control - Part 2: Formal models (ISO 22600-2:2014) |
2014-10-15 |
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EN ISO 22600-3:2014
(WI=00251286) Health informatics - Privilege management and access control - Part 3: Implementations (ISO 22600-3:2014) |
2014-10-15 |
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EN ISO 23903:2021
(WI=00251360) Health Informatics - Interoperability and integration reference architecture - Model and framework (ISO 23903:2021, Corrected version 2021-07) |
2021-04-21 |
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EN ISO 25237:2017
(WI=00251316) Health informatics - Pseudonymization (ISO 25237:2017) |
2017-01-25 |
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EN ISO 27269:2022
(WI=00251375) Health informatics - International patient summary (ISO 27269:2021) |
2022-03-30 |
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EN ISO 27789:2021
(WI=00251343) Health informatics - Audit trails for electronic health records (ISO 27789:2021) |
2021-10-20 |
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EN ISO 27799:2016
(WI=00251302) Health informatics - Information security management in health using ISO/IEC 27002 (ISO 27799:2016) |
2016-08-10 |
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EN ISO 27953-1:2011
(WI=00251238) Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011) |
2011-12-01 |
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EN ISO 27953-2:2011
(WI=00251239) Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) |
2011-12-01 |
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EN ISO/IEEE 11073-10201:2020
(WI=00251350) Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE 11073-10201:2020) |
2020-06-03 |
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EN ISO/IEEE 11073-10404:2022
(WI=00251381) Health informatics - Device interoperability - Part 10404: Personal health device communication - Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-10407:2022
(WI=00251382) Health informatics - Device interoperability - Part 10407: Personal health device communication - Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-10408:2022
(WI=00251383) Health informatics - Device interoperability - Part 10408: Personal health device communication - Device specialization - Thermometer (ISO/IEEE 11073-10408:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-10415:2022
(WI=00251384) Health informatics - Device interoperability - Part 10415: Personal health device communication - Device specialization - Weighing scale (ISO/IEEE 11073-10415:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-10419:2023
(WI=00251389) Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019) |
2023-08-30 |
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EN ISO/IEEE 11073-10420:2022
(WI=00251386) Health informatics - Device interoperability - Part 10420: Personal health device communication - Device specialization - Body composition analyzer (ISO/IEEE 11073-10420:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-20601:2022
(WI=00251385) Health informatics - Device interoperability - Part 20601: Personal health device communication - Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2022) |
2022-12-21 |
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EN ISO/IEEE 11073-40101:2022
(WI=00251374) Health informatics - Device interoperability - Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment (ISO/IEEE 11073-40101:2022) |
2022-03-30 |
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EN ISO/IEEE 11073-40102:2022
(WI=00251373) Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022) |
2022-03-30 |
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