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CEN/TC 251 - Published standards

Standard referenceTitleDirective
(Citation in OJEU*)		Sales Points
CEN/TR 15212:2006Health informatics - Vocabulary - Maintenance procedure for a web-based terms and concepts database-
CEN/TR 15253:2005Health informatics - Quality of service requirements for health information interchange-
CEN/TR 15299:2006Health informatics - Safety procedures for identification of patients and related objects-
CEN/TR 15300:2006Health informatics - Framework for formal modelling of healthcare security policies-
CEN/TR 15640:2007Health informatics - Measures for ensuring the patient safety of health software-
CEN/TS 14822-4:2005Health informatics - General purpose information components - Part 4: Message headers-
CEN/TS 15260:2006Health informatics - Classification of safety risks from health informatics products-
CR 12161:1995A method for defining profiles for healthcare-
CR 12587:1996Medical Informatics - Methodology for the development of healthcare messages-
CR 1350:1993Investigation of syntaxes for existing interchange formats to be used in health care-
CR 13694:1999Health Informatics - Safety and Security Related Software Quality Standards for Healthcare (SSQS)-
CR 14301:2002Health informatics - Framework for security protection of healthcare communication-
CR 14302:2002Health informatics - Framework for security requirements for intermittently connected devices-
EN 1064:2005+A1:2007Health informatics - Standard communication protocol - Computer-assisted electrocardiography-
EN 1068:2005Health informatics - Registration of coding systems-
EN 12251:2004Health informatics - Secure User Identification for Health Care - Management and Security of Authentication by Passwords-
EN 12264:2005Health informatics - Categorial structures for systems of concepts-
EN 12381:2005Health informatics - Time standards for healthcare specific problems-
EN 12435:2006Health informatics - Expression of results of measurements in health sciences-
EN 13606-2:2007Health informatics - Electronic health record communication - Part 2: Archetypes interchange specification-
EN 13606-3:2008Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists-
EN 13606-4:2007Health informatics - Electronic health record communication - Part 4: Security-
EN 13609-1:2005Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 1: Updating of coding schemes-
EN 13940-1:2007Health informatics - System of concepts to support continuity of care - Part 1: Basic concepts-
EN 14484:2003Health informatics - International transfer of personal health data covered by the EU data protection directive - High level security policy-
EN 14485:2003Health informatics - Guidance for handling personal health data in international applications in the context of the EU data protection directive-
EN 14822-1:2005Health informatics - General purpose information components - Part 1: Overview-
EN 14822-2:2005Health informatics - General purpose information components - Part 2: Non-clinical-
EN 14822-3:2005Health informatics - General purpose information components - Part 3: Clinical-
EN 15521:2007Health informatics - Categorial structure for terminologies of human anatomy-
EN 1614:2006Health informatics - Representation of dedicated kinds of property in laboratory medicine-
EN ISO 10781:2009Electronic Health Record-System Functional Model, Release 1.1 (ISO 10781:2009)-
EN ISO 11073-10101:2005Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature (ISO/IEEE 11073-10101:2004)-
EN ISO 11073-10201:2005Health informatics - Point-of-care medical device communication - Part 10201: Domain information model (ISO/IEEE 11073-10201:2004)-
EN ISO 11073-10404:2011Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2010)-
EN ISO 11073-10406:2012Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)-
EN ISO 11073-10407:2011Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)-
EN ISO 11073-10408:2011Health informatics - Personal health device communication - Part 10408: Device specialization - Thermometer (ISO/IEEE 11073-10408:2010)-
EN ISO 11073-10415:2011Health informatics - Personal health device communication - Part 10415: Device specialization - Weighing scale (ISO/IEEE 11073-10415:2010)-
EN ISO 11073-10417:2011Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2010)-
EN ISO 11073-10420:2012Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012)-
EN ISO 11073-10421:2012Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012)-
EN ISO 11073-10471:2011Health Informatics - Personal health device communication - Part 10471: Device specialization - Independant living activity hub (ISO/IEEE 11073-10471:2010)-
EN ISO 11073-10472:2012Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)-
EN ISO 11073-20101:2005Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004)-
EN ISO 11073-20601:2011Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2010)-
EN ISO 11073-30200:2005Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected (ISO/IEEE 11073-30200:2004)-
EN ISO 11073-30300:2005Health informatics - Point-of-care medical device communication - Part 30300: Transport profile - Infrared wireless (ISO/IEEE 11073-30300:2004)-
EN ISO 11073-30400:2012Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)-
EN ISO 11238:2012Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)-
EN ISO 11239:2012Health 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 11239:2012)-
EN ISO 11240:2012Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)-
EN ISO 11615:2012Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)-
EN ISO 11616:2012Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)-
EN ISO 12052:2011Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2006)-
EN ISO 12967-1:2011Health informatics - Service architecture - Part 1: Enterprise viewpoint (ISO 12967-1:2009)-
EN ISO 12967-2:2011Health informatics - Service architecture - Part 2: Information viewpoint (ISO 12967-2:2009)-
EN ISO 12967-3:2011Health informatics - Service architecture - Part 3: Computational viewpoint (ISO 12967-3:2009)-
EN ISO 13119:2012Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)-
EN ISO 13120:2013Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2013)-
EN ISO 13606-1:2012Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008)-
EN ISO 13606-5:2010Health informatics - Electronic health record communication - Part 5: Interface specification (ISO 13606-5:2010)-
EN ISO 18104:2003Health Informatics - Integration of a reference terminology model for nursing (ISO 18104:2003)-
EN ISO 1828:2012Health informatics - Categorial structure for terminological systems of surgical procedures (ISO 1828:2012)-
EN ISO 18812:2003Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)-
EN ISO 21090:2011Health Informatics - Harmonized data types for information interchange (ISO 21090:2011)-
EN ISO 21091:2013Health informatics - Directory services for healthcare providers, subjects of care and other entities (ISO 21091:2013)-
EN ISO 21549-1:2004Health informatics - Patient healthcard data - Part 1: General structure (ISO 21549-1:2004)-
EN ISO 21549-2:2004Health informatics - Patient healthcard data - Part 2: Common objects (ISO 21549-2:2004)-
EN ISO 21549-3:2004Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO 21549-3:2004)-
EN ISO 21549-4:2006Health informatics - Patient healthcard data - Part 4: Extended clinical data (ISO 21549-4:2006)-
EN ISO 21549-5:2008Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2008)-
EN ISO 21549-6:2008Health informatics - Patient healthcard data - Part 6: Administrative data (ISO 21549-6:2008)-
EN ISO 21549-7:2007Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2007)-
EN ISO 21549-8:2010Health informatics - Patient healthcard data - Part 8: Links (ISO 21549-8:2010)-
EN ISO 27789:2013Health informatics - Audit trails for electronic health records (ISO 27789:2013)-
EN ISO 27799:2008Health informatics - Information security management in health using ISO/IEC 27002 (ISO 27799:2008)-
EN ISO 27953-1:2011Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011)-
EN ISO 27953-2:2011Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)-
ENV 12443:1999Medical Informatics - Healthcare Information Framework (HIF)-
ENV 12537-1:1997Medical informatics - Registration of information objects used for EDI in healthcare - Part 1: The Register-
ENV 12610:1997Medical informatics - Medicinal product identification-
ENV 12611:1997Medical informatics - Categorial structure of systems of concepts - Medical devices-
ENV 12612:1997Medical informatics - Messages for the exchange of healthcare administrative information-
ENV 13607:2000Health informatics - Messages for the exchange of information on medicine prescriptions-
ENV 13609-2:2000Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information-
ENV 13730-1:2001Health informatics - Blood transfusion related messages - Part 1: Subject of care related messages-
ENV 13730-2:2002Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD)-

(*) OJEU - Official Journal of the European Union

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