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Information Technology, Information Technology Applications, Information Technology Applications Standards in Health Technology

Our company performs the testing, auditing and certification of all the standards mentioned below. We carry out your test, audit and certification processes as experienced and professional in the control of Information Technology Applications in Health Technology. 

 

TS EN 1828 Health Informatics-Categorical structure for classifications and coding of surgical procedures  

TS ENV 13735 Health Informatics - Interoperability of patient-connected medical devices   

TS ENV 13608-1 Health Informatics-Health Service Communication Security-Part 1: Concepts and Terminology  

TS ENV 13608-2 Health informatics-Health care communication security-Part 2: Safety data objects  

TS ENV 13608-3 Health informatics-Health care communication security-Part 3: Secure data channels

TS ENV 13607 / T1 Health Informatics-Messages for exchange of information on drug prescriptions 

TS EN 12281 Printing and office paper - Copy paper specifications for dry toner copying  

TS EN 12381 Health Informatics - Time standards for problems specific to health care  

TS EN 1614 Health Informatics-Coding, classification and terminological structure of features in clinical laboratory sciences

TS EN 13606-2 Health informatics - Electronic health record communication - Part 2: Specification for the exchange of prototypes

TS EN ISO 21549-6 Health informatics - Patient healthcard data - Part 6: Administrative data

TS EN ISO 13606-5 Health informatics - Electronic health records communication - Part 5: Interface properties  

TS EN 62304 / AC: 2008 Medical device software - Software life cycle processes  

TS EN ISO 11073-10404 Health Informatics-Personal Health Device Communication- Part 10404: Device Identification- Pulse Oximeter 

TS EN ISO 11073-10407 Health informatics-Personal health device communication- Part 10407: Device identification- Blood pressure monitoring  

TS EN ISO 11073-10408 Health informatics-Personal health device communication- Part 10408: Device identification- Thermometer 

TS EN ISO 11073-10415: 2011 Health informatics-Personal health device communication- Part 10415: Device identification- Weighing instrument

TS EN ISO 12967-1 Health Informatics- Service Architecture - Part 1: Investment Perspective  

TS EN ISO 12967-2 Health Informatics - Service Architecture - Part 2: Information Perspective  

TS EN 80001-1: 2011 Application of risk management for IT networks for medical devices - Part 1: Roles, responsibilities and activities  

TS EN ISO 11073-10471 Health informatics-Medical device communication point of care- Section 10471: Device identification- Independent live activity center  

TS EN ISO 27953-1 Health informatics-Single safety reports in pharmacovigilance (ICSRS) -Chapter 1: Framework for adverse event reporting 

ISO EN 27953-2: 2011 (IT) Health Informatics-Single Safety Reports in Pharmacovigilance (ICSRS)

TS EN ISO 13606-1 Health Informatics-Electronic health records communication-Section1: Reference model 

TS EN ISO 11073-10406 Health informatics - Personal health device communication - Part 10406: Device expertise - Basic electrocardiography (ECG) (for 1 - 3-derivated ECG)

TS EN ISO 11073-10421 Health Informatics - personal health device communication - Part 10421: Specialized device - Stream Monitor between peak (peak current)  

TS EN ISO 11073-10472 Health Informatics - Personal Health Device Communication - Part 10472: Device Specialized - Pharmaceutical Monitor  

TS EN ISO 11073-10420 Health Informatics - Personal Health Device Communication - Part 10420: Specialized Device - Analyze Body Composition 

TS EN ISO 11073-30400 Health Informatics - point of care medical device communication - part 30400: Interface profile - wired Ethernet 

TS EN ISO 11239 Health Informatics - identification of medicinal products - data items and structures diagnostic and presentation of drug dose forms, exchange of information arranged for route management and packaging,  

TS EN ISO 11238 Health Informatics - identification of medicinal products - data items and structures for regular exchange of information on substances and diagnostic code 

TS EN ISO 11240 Health Informatics - identification of medicinal products - a unique exchange of identities and units of measure for data elements and structures  

TS EN ISO 11615 Health Informatics - identification of medicinal products - unique identity for data items and structures, and regulated medical product information exchange  

TS EN ISO 11616 Health Informatics - identification of medicinal products - unique identity for data items and structures and regular drug product information exchange  

TS EN ISO 13119 Health Informatics - clinical information sources - metadata  

TS ISO 1828 Healthcare Informatics - Categorial structure for terminological systems of surgical interventions 

TS EN ISO 21091 Health informatics - Directory services for health care, care issues and other organizations

TS EN ISO 27789 Healthcare informatics - Audit paths for electronic health records  

TS EN ISO 13120 Health informatics - Syntax for representing the content of health classification systems - Classification Markup Language (ClaML) 

TS EN ISO 21549-1 Health care - quality criteria for health checks  

TSE CEN ISO / TS 14265 Health Informatics - Classification of purposes for processing personal health information 

Health informatics - Medical device communication - Part 11073: Nomenclature - Implantable device, cardiac 

TS EN ISO 11073-10102 Health informatics - External test medical device communication - Part 10101: Nomenclature - ECG with annotation (ISO / IEEE 11073-10102: 2014) 

TS EN ISO 11073-10418 Health informatics-Personal health device communication- Part 10418: Device specialization - International Normalized Rate (INR) monitor (ISO / IEEE 11073-10418: 2014) 

TS EN ISO 18104 Healthcare informatics - Integration of a reference terminology model for patient care  

TS EN ISO 21549-2 Health informatics - Patient health card data - Part 2: Common objects (ISO 21549-2: 2014)  

TS EN ISO 21549-4 Health informatics - Patient health card data - Part 4: Extended clinical data 

TS EN ISO 21549-3 Health informatics - Patient health card data - Part 3: Limited clinical data  

TSE CEN / TR 15872 Health informatics - Guidance on cross-reference of patient identities and identities  

TS EN ISO 11073-10417 Health informatics-Personal health device communication- Part 10417: Device identification- Glucose meter  

TS EN ISO 22600-1 Health informatics - Privilege management and access control - Part 1: General and policy management  

TS EN ISO 22600-2 Health informatics - Privilege management and access control - Part 2: Formal models  

TS EN ISO 22600-3 Health informatics - Privilege management and access control - Part 3: Applications   

Health informatics - Medical device communication - Part 11073: Nomenclature - Implantable device, cardiac 

TS EN ISO 10781 Health Informatics - HL7 Electronic Health Records - System Functional Model, Version2 (EHR FM)  

TS EN ISO 13940 Health informatics - Concepts system to support continuity of care  

TS EN ISO 11073-30200 / A1 Health Informatics - External Test Medical Device Communication - Part 30200: Transport Profile - Connected Cables - Modified 1 

TSE CEN ISO / TS 16791 Health Informatics - International machine readable medical product package with descriptive coding requirements 

TSE CEN ISO / TS 13972 Healthcare informatics - Detailed clinical models, features and processes  

TSE CEN ISO / TS 18530 Health Informatics - Automatic identification and data marking capture and labeling - Patient and healthcare worker identification  

TSE CEN ISO / TS 19844 Health informatics - Identification of medicinal products - Application of data elements and structures for individual identification of substances and legally regulated information exchange  

TS EN ISO 16278 Health informatics - Categorical structure for human anatomy terminology  

TS EN ISO 21549-5 Health informatics - Patient health card data - Part 5: Identification data  

TSE N ISO 11073-10424 Health informatics - Personal health device communication - Part 10424: Device description - Sleep apnea respiratory therapy equipment (SABTE)  

TS EN ISO 11073-10425 Health informatics - Personal health device communication - Part 10425: Device description - Continuous glucose monitoring device (CGM)  

TS EN ISO 11073-10419 Health informatics - Personal health device communication - Part 10419: Device description - Insulin pump  

TS EN ISO 17523 Health Informatics - Requirements for Electronic Prescriptions 

TSE CEN ISO / TS 17251 Healthcare informatics - Business requirements for a syntax used to exchange structured dose information in medical products  

TSE CEN ISO / TS 20440 Health informatics - Identification of medicinal products - Legally regulated drug dose forms, presentation units, management routes, and application of ISO 11239 data elements and structures for packaging information identification and transfer  

TS EN ISO 11073-20601 Health informatics-Personal health device communication- Part 20601: Application profile- Optimized exchange protocol  

TS EN ISO 27799 Health informatics - Information security management in health using the ISO / IEC 27002 standard  

TS EN ISO 15225 Medical devices - Quality management - Medical device naming data structure  

Health informatics - Personal health device communication - Part 11073: Device customization - International Normalized Rate (INR) monitor - Technical Correction 10418 TS EN ISO 10418-1 / AC  

TS EN ISO 25237 Health Informatics - Fake credentials  

TS EN ISO 21549-7 Health informatics - Patient health card data - Part 7: Treatment data  

TS EN ISO 11073-00103 Health informatics - Personal health device communication - Part 00103: General  

TS EN ISO 11073-10441 Health informatics - Personal health device communication - Part 10441: Device customization - Cardiovascular health and activity monitoring  

TS EN ISO 11073-10442 Health informatics - Personal health device communication - Part 10442: Device customization - Strength health equipment

TS EN ISO 21298 Health informatics - Functional and structural roles  

TSE CEN ISO / TS 19256 Health Informatics - Requirements for medical product dictionary systems for health care  

TS EN ISO 12967-3: 2011 Health Informatics- Service Architecture-Part 3: Calculation Perspective  

TS EN 1064 + A1 Health informatics -Standard communication protocol-Computer assisted electrocardiography  

TS EN 1068 Health Informatics - Registration of coding systems  

tst ENV 1614 Health Informatics - Coding, classification, terminological structure of properties in clinical laboratory units    

tst EN 1828 Medical informatics - Structure for coding and classification of surgical procedures

TS EN ISO 11073-20101 Health Informatics - External Test Medical Device Communication - Part 20101: Application Profile - Base Standard 

TS EN ISO 11073-10101 Health informatics - External test medical device communication - Part 10101: Nomenclature  

TS EN ISO 11073-10201 Health informatics - External test medical device communication - Part 30300: Field information model  

TS EN ISO 11073-30300 Health Informatics - External Test Medical Device Communication - Part 30200: Transport Profile - Wireless Infrared  

TS EN ISO 11073-30200 Health Informatics - External Test Medical Device Communication - Part 30200: Transport Profile - Connected Cables

TS EN 12251 Health Informatics-Secure user identification for health care-Security and management of password authentication 

TS EN 12264 Medical informatics - Categorical structures of concept systems - Model for representation of semantics

tst ENV 13606-3 Health informations - Electronic health records communication - Part 3: Distribution rules  

tst ENV 13606-4 Health informations - Electronic health records communication - Part 4: Information exchange messages  

Health informatics - Electronic health records communication - Part 13606: Enhanced architecture TS ENV 1-1 / tst T1

TS EN 13606-3 Health informations - Electronic health records communication - Part 3: Distribution rules  

TS EN 13606-4 Health informatics - Electronic health record communication - Part 4: Security 

TS ENV 13607 Health Informatics-Messages for exchange of information on drug prescriptions 

TS ENV 13608-1 / tst T1 Health Informatics-Health Service Communication Security-Part 1: Concepts and Terminology   

TS ENV 13608-2 / tst T1 Health Informatics-Health Service Communication Security-Part 2: Security Data Objects   

TS ENV 13608-3 / tst T1 Health Informatics-Health Service Communication Security-Part 3: Secure Data Channels   

TS EN 13609-1 Health informatics - Messages for the maintenance of supporting information in health care systems  

TS ENV 13729 Health combinations - Security user identification - Strong authentication using microprocessor cards 

Health Informatics - Interoperability of patient-connected medical devices TS ENV 13735 / tst T1    

tst ENV 13939 Healthcare Informatics - Medical data exchange: HIS / RIS-Pacs and HIS / RIS - Modality interface   

TS EN 14484 Health Informatics - International transfer of personal health data under the EU data protection directives 

TS EN 14485 Health Informatics - Guidance on handling personal health data in international practice in the context of EU data protection directives

TS EN 14822-1 Health informatics - General information components - Part 1: Overview  

TS EN 14822-2 Health Informatics - General purpose information components - Part 2: Non-clinical components 

TS EN 14822-3 Health Informatics - General information components - Part 3: Clinical 

TSE CEN / TS 14822-4 Health Informatics - General Purpose Components - Part 4: Message Headers

TSE CEN / TR 15640 Health informatics - Criteria for ensuring patient safety in health software 

TS ISO 18308 Health Informatics - Rules for Electronic Health Record Architecture 

TS EN ISO 18812 Healthcare Informatics - Clinical analyzer interfaces of laboratory information systems - User profiles 

TS EN ISO 21090: 2011 Health informatics - Harmonized data types for information exchange

TS EN ISO 21549-8: 2010 Health informatics - Patient health card data - Part 8: Links 

TS EN 60601-2-44 Electrical medical devices - Part 2-44: Particular requirements for the safety of x-ray equipment in computed tomography

TS EN 61223-2-6 Evaluation and routine tests in medical imaging departments - Invariance tests - Part 2-6: Imaging performance of computed tomography x-ray equipment