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Medical Bioinformatics

Medical Bioinformatics, Total:499 items.

In the international standard classification, Medical Bioinformatics involves: Applications of information technology, Vocabularies, Services, Information sciences. Publishing, Medical sciences and health care facilities in general, Wastes, Sterilization and disinfection, Medical equipment, Laboratory medicine, Technical product documentation, Pharmaceutics, Microbiology, Animal feeding stuffs, Character sets and information coding, Biology. Botany. Zoology, Fishing and fish breeding, Software development and system documentation, Graphical symbols, Veterinary medicine, Bottles. Pots. Jars, Protection against dangerous goods, Water quality, Dentistry, Data storage devices, HEALTH CARE TECHNOLOGY.

British Standards Institution (BSI), Medical Bioinformatics

DD ENV 13607-2000 Health informatics. Messages for the exchange of information on medicine prescriptions
DD ENV 12017-1998 Medical informatics. Medical informatics vocabulary (MIVoc)
BS DD ENV 12443:2001 Medical informatics - Healthcare information framework (HIF)
DD ENV 12052-1998 Medical informatics. Medical imaging communication (MEDICOM)
DD ENV 12610-1998 Medical informatics. Medical product identification
BS DD ENV 12612:1998 Medical informatics - Messages for the exchange of healthcare administrative information
BS DD ENV 13735:2001 Health informatics - Interoperability of patient connected medical devices
BS DD CEN/TS 14463:2003 Health informatics - A syntax to represent the content of medical classification systems (CIaML)
DD ENV 12443:2001 Medical informatics. Healthcare information framework (HIF)
BS DD ENV 12537-1:1998 Medical informatics - Registration of information objects used for EDI in healthcare - The register
DD ENV 13730-2:2002 Healthcare informatics. Blood transfusion related messages. Production related messages (BTR-PROD)
DD ENV 12443-2001 Medical informatics. Healthcare information framework (HIF)
PD 6610:1997 Medical informatics. Methodology for the development of healthcare messages
DD ENV 12538-1998 Medical informatics. Messages for patient referral and discharge
PD ISO/TS 22077-5:2021 Health informatics. Medical waveform format. Neurophysiological signals
DD ENV 12623-1998 Medical informatics. Media interchange in Medical imaging communications (MI-MEDICOM)
BS DD ENV 12610:1998 Medical informatics - Medical product identification
DD ENV 12610:1998 Medical informatics. Medical product identification
BS DD ENV 12538:1998 Medical informatics - Messages for patient referral and discharge
BS PD ISO/TS 22077-5:2021 Health informatics. Medical waveform format. Neurophysiological signals
DD ENV 12435-2000 Medical informatics. Expression of results of measurements in health sciences
PD 6610-1997 Medical informatics. Methodology for the development of healthcare messages
DD ENV 12612-1998 Medical informatics. Messages for the exchange of healthcare administrative information
DD ENV 12612:1998 Medical informatics. Messages for the exchange of healthcare administrative information
BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
DD ENV 13609-2:2000 Healthcare informatics. Messages for maintenance of supporting information in healthcare systems. Updating of medical laboratory-specific information
BS EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
BS DD ENV 13607:2000 Health informatics - Messages for the exchange of information on medicine prescriptions
DD ENV 12611-1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS DD ENV 12611:1998 Medical informatics - Categorical structure of systems of concepts - Medical devices
DD ENV 1613-1996 Medical informatics. Messages for exchange of laboratory information
BS DD ENV 1613:1996 Medical informatics - Messages for exchange of laboratory information
BS PD CEN/TR 15640:2007 Health informatics — Measures for ensuring the patient safety of health software
PD ISO/TR 11633-2:2021 Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Implementation of an information security management system (ISMS)
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
BS PD ISO/TR 11633-2:2021 Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Implementation of an information security management system (ISMS)
BS EN 1041:2008 Information supplied by the manufacturer of medical devices
BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
BS EN 1041:1998 Information supplied by the manufacturer with medical devices
BS EN ISO 20417:2021 Tracked Changes. Medical devices. Information to be supplied by the manufacturer
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
PD ISO/TS 11633-1:2019 Tracked Changes. Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Requirements and risk analysis
DD ENV 12537-1:1998 Medical informatics. Registration of information objects used for EDI in healthcare.. The register
BS DD ENV 13939:2002 Health informatics - Medical data interchange: HIS/RIS-PACS and HIS/RIS - Modality interface
BS DD ISO/TS 22220:2011 Health informatics. Identification of subjects of health care
DD ENV 12539-1998 Medical informatics. Request and report messages for diagnostic service departments
DD ENV 12924-1998 Medical informatics. Security categorisation and protection for healthcare information systems
PD ISO/TR 18638:2017 Health informatics. Guidance on health information privacy education in healthcare organizations
BS ISO 13606-2:2008 Health informatics - Electronic health record communication - Archetype interchange specification
BS ISO 14199:2015 Health informatics. Information models. Biomedical Research Integrated Domain Group (BRIDG) Model
BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
BS ISO/IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication. Medical devices communication profile for web services
BS 5213:1975 Specification for medical specimen containers for microbiology
DD ENV 12611:1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS DD CEN/TS 14822-4:2008 Health informatics. General purpose information components. Message headers
BS DD CEN/TS 14822-4:2005 Health informatics — General purpose information components — Part 4: Message headers
BS EN 12967-3:2007 Health informatics. Service architecture. Computational viewpoint
DD ISO/TS 22220:2011 Health informatics. Identification of subjects of health care
PD ISO/TS 22077-2:2015 Health informatics. Medical waveform format. Electrocardiography
DD ENV 12537-1-1998 Medical informatics. Registration of information objects used for EDI in healthcare. The register
BS EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS EN ISO 11073-10101:2006 Health informatics - Point-of-care medical device communications - Nomenclature
BS EN ISO 10993-1:2003 Biological evaluation of medical devices - Evaluation and testing
BS ISO 22077-1:2015 Health informatics. Medical waveform format. Encoding rules
BS DD ISO/TS 11073-92001:2007 Health informatics - Medical waveform format - Encoding rules
BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
BS EN ISO 11073-10201:2006 Health informatics - Point-of-care medical device communication - Domain information model
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes
BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
23/30461124 DC BS ISO 14199. Health informatics. Information models. Biomedical Research Integrated Domain Group (BRIDG) Model
BS EN ISO 21549-5:2008 Health informatics - Patient healthcard data - Identification data
BS DD ENV 14032:2002 Health informatics - System of concepts to support nursing
BS DD CEN/TS 14271:2003 Health informatics - File exchange format for vital signs
BS DD CEN/TS 14271:2004 Health informatics. File exchange format for vital signs
BS EN ISO 21549-6:2008 Health informatics - Patient healthcard data - Administrative data
BS EN ISO 18104:2014 Health informatics. Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems
BS EN ISO 21549-5:2016 Health informatics. Patient healthcard data. Identification data
BS EN ISO 21549-2:2014 Health informatics. Patient healthcard data. Common objects
PD ISO/TS 22077-3:2015 Health informatics. Medical waveform format. Long term electrocardiography
BS EN 1614:2006 Health informatics - Representation of dedicated kinds of property in laboratory medicine
BS DD CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 17664-1:2021 Tracked Changes. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
BS EN ISO/IEEE 11073-10201:2020 Health informatics. Device interoperability - Point-of-care medical device communication. Domain information model
BS EN ISO 11238:2012 Health informatics. Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
BS EN ISO 11615:2012 Health informatics. Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product information
BS EN ISO 7405:2018 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
BS EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
BS EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
BS EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
BS EN ISO 11138-3:2017 Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes

Danish Standards Foundation, Medical Bioinformatics

DS/ENV 12443:2000 Medical Informatics - Healthcare Information Framework (HIF)
DS/CEN/CR 12587:1997 Medical Informatics - Methodology for the development of healthcare messages
DS/ENV 12612:1997 Medical informatics - Messages for the exchange of healthcare administrative information
DS/ENV 13730-2:2002 Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD)
DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
DS/ENV 1068:1993 Medical informatics. Healthcare information interchange. Registration of coding schemes
DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
DS/EN 1041+A1:2013 Information supplied by the manufacturer of medical devices
DS/ISO/TR 11633-2:2021 Health informatics – Information security management for remote maintenance of medical devices and medical information systems – Part 2: Implementation of an information security management system (ISMS)
DS/CEN/CR 14301:2002 Health informatics - Framework for security protection of healthcare communication
DS/ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer
DS/ENV 12611:1997 Medical informatics - Categorial structure of systems of concepts - Medical devices
DS/ENV 12537-1:1997 Medical informatics - Registration of information objects used for EDI in healthcare - Part 1: The Register
DS/EN ISO 11073-10201:2005 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DS/EN ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer (ISO 20417:2021)
DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
DS/ENV 13609-2:2000 Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information
DS/EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
DS/EN ISO 7405:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

AENOR, Medical Bioinformatics

UNE-ENV 12443:2000 Medical Informatics - Healthcare Information Framework (HIF)
UNE-ENV 12612:1998 MEDICAL INFORMATICS. MESSAGES FOR THE EXCHANGE OF HEALTHCARE ADMINISTRATIVE INFORMATION.
UNE-ENV 12924:1998 MEDICAL INFORMATICS. SECURITY CATEGORISATION AND PROTECTION FOR HEALTHCARE INFORMATION SYSTEMS.
UNE-EN 1041:2009+A1:2014 Information supplied by the manufacturer of medical devices
UNE-EN 475:1996 MEDICAL DEVICES. ELECTRICALLY-GENERATED ALARM SIGNALS.
UNE-ENV 12611:1998 MEDICAL INFORMATICS. CATEGORIAL STRUCTURE OF SYSTEMS OF CONCEPTS. MEDICAL DEVICES.
UNE-ENV 12388:1997 MEDICAL INFORMATICS. ALGORITHM FOR DIGITAL SIGNATURE SERVICES IN HEALTH CARE.
UNE-EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

Jiangsu Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB32/T 4008-2021 Regulations on the Collection of Medical and Health Credit Information
DB32/T 3548-2019 Guidelines for the Construction of Online Traceability Management Information System for Medical Waste in Medical Institutions
DB32/T 3549-2019 Specifications for setting up facilities and equipment for temporary storage of medical waste in medical and health institutions
DB32/T 3769-2020 Basic requirements for medical device network information security
DB32/T 4529-2023 Technical operating procedures for vector control in medical institutions

German Institute for Standardization, Medical Bioinformatics

DIN V ENV 12610:1997 Medical informatics - Medicinal product identification; English version ENV 12610:1997
DIN V ENV 12612:1997 Medical informatics - Messages for the exchange of healthcare administrative information; English version ENV 12612:1997
DIN V ENV 12443:2000 Medical informatics - Healthcare Information Framework (HIF); English version ENV 12443:1999
DIN EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
DIN-Fachbericht 73:1998 Medical informatics - Methodology for the development of healthcare messages - CEN-Report 12587
DIN V ENV 13606-4:2000-09 Health informatics - Electronic healthcare record communication - Part 4: Messages for the exchange of information; English version ENV 13606-4:2000 / Note: To be replaced by DIN EN 13606-4 (2006-05), DIN EN ISO 13606-5 (2008-06).
DIN EN 1041:2008 Information supplied by the manufacturer of medical devices; German version EN 1041:2008
DIN EN 12967-2:2008 Health informatics - Service architecture - Part 2: Information viewpoint; English version EN 12967-2:2007
DIN V ENV 12537-1:1997 Medical informatics - Registration of information objects used for EDI in healthcare - Part 1: The register; English version ENV 12537-1:1997
DIN V ENV 13606-4:2000 Health informatics - Electronic healthcare record communication - Part 4: Messages for the exchange of information; English version ENV 13606-4:2000
DIN V ENV 12611:1997 Medical informatics - Categorial structure of systems of concepts - Medical devices; English version ENV 12611:1997
DIN EN ISO 17664-1:2021-11 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
DIN EN ISO 11073-10201:2006 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model (ISO/IEEE 11073-10201:2004); English version EN ISO 11073-10201:2005
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN 58959 Bb.1:1997 Quality management in medical microbiology - Overview and index
DIN EN 12435:2006 Health Informatics - Expression of results of measurements in health sciences; English version EN 12435:2006
DIN EN ISO 20417:2019 Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019); German and English version prEN ISO 20417:2019
DIN EN ISO 18113-2:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 / Note: DIN EN ISO 18113-2 (2010-05) remains v...
DIN EN ISO 18113-3:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 / Note: DIN EN ISO 18113-3 (2010-05) remain...
DIN EN ISO 18113-4:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 / Note: DIN EN ISO 18113-4 (2010-05) remains valid...
DIN EN ISO 18113-3:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 / Note: Date of issue 202...
DIN EN ISO 18113-4:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021 / Note: Date of issue 2021-08-06...
DIN EN ISO 18113-2:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021 / Note: Date of issue 2021-0...
DIN EN ISO 18113-1:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 / Note: Date of issue 2021-08-06*I...
DIN EN ISO 18113-5:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 / Note: DIN EN ISO 18113-5 (2010-05) remains va...
DIN EN ISO 18113-1:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 / Note: DIN EN ISO 18113-1 (2010-05) remains valid a...
DIN EN ISO 18113-5:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021 / Note: Date of issue 2021-08...
DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
DIN CEN/TS 15260:2007 Health informatics - Classification of safety risks from health informatics products; German and English version CEN/TS 15260:2006
DIN EN ISO 7405:2019-03 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018

Group Standards of the People's Republic of China, Medical Bioinformatics

T/CIATCM 046-2019 Data element dictionary for the platform of health information in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 047-2019 Classification and coding for value domain for the platform of health information in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 049-2019 Basic datasets for the health Information of basic medical care information system in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 048-2019 Functional specification of basic medical management information system in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 045-2019 Basic datasets for the Information of knowledge base in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 051-2019 Basic datasets for the platform of preventive treatment of diseases in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 053-2019 Basic datasets for teleconsultation in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 054-2019 Guidelines on construction of information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 043-2019 Guidlines on construction of the platform of health information in Traditional Chinese Medicine section in primary medical and health care institutions
T/CIATCM 050-2019 Functional specification of the information system for preventive treatment of diseases in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 044-2019 Functional specification of the information system for knowledge in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 055-2019 Functional specification of the information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 052-2019 Functional specification of teleconsultation information system in Traditional Chinese Medicine section in primary medical and health care institution
T/CHIA 13-2018 Medical and Healthcare IoT-Fusion Model for Sensed Information of Human Body
T/CIATCM 077-2020 Information data element dictionary of medical quality control of Traditional Chinese Medicine hospitale
T/CIATCM 037-2019 Profiling framework and classification for Traditional Chinese medical care informatics standards development
T/JSCC 004-2022 Functional specification of telemedicine information system
T/CIATCM 078-2020 Classification and coding for value domain of information data element dictionary of medical quality control of Traditional Chinese Medicine hospital
T/WSJD 23.1-2022 Guidelines for On-line Monitoring of Medical Waste in Medical and Health Institutions Part I General Principles
T/GDC 236-2023 Application and Information Technology Specification for Logistics Robot Business in Medical Institutions
T/WSJD 39-2023 Requirements for the item information traceability system of the disinfection supply center of medical institutions
T/ZMDS 20003-2019 Medical device security risk control – information of medical device security capabilities
T/CIATCM 022-2019 Classification and codes of special treatments in Traditional Chinese Medicine
T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices

CEN - European Committee for Standardization, Medical Bioinformatics

DD ENV 12924-1997 Medical Informatics - Security Categorisation and Protection for Healthcare Information Systems
DD ENV 12381-1996 Health Care Informatics - Time Standards for Healthcare Specific Problems
EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Association Francaise de Normalisation, Medical Bioinformatics

NF EN 14822-3:2007 Informatique de la santé - Composants d'information d'usage général - Partie 3 : informations médicales
FD S97-513*FD CR 12587:1997 Methodology for the development of healthcare messages.
NF S97-500*NF EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
NF S92-040*NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
NF S99-003:2008 Information supplied by the manufacturer of medical devices.
NF S99-003:1998 Information supplied by the manufacturer with medical devices.
NF S97-530:2002 Medical informatics - Messages concerning blood transfusion - Communication and data model.
NF S99-003/IN1:2013 Information supplied by the manufacturer of medical devices
NF S99-003:2013 Information supplied by the manufacturer of medical devices
NF S99-001*NF EN ISO 20417:2021 Medical devices - Information to be provided by the manufacturer
NF S97-512*NF EN 1614:2006 Health Informatics - Representation of dedicated kinds of property laboratory medicine
NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF EN 14822-2:2007 Informatique de la santé - Composants d'information d'usage général - Partie 2 : informations non médicales
NF S97-549-7:2008 Health informatics - Patient healthcard data - Part 7 : medication data.
NF EN ISO 20417:2021 Dispositifs médicaux - Informations à fournir par le fabricant
NF EN ISO 19001:2013 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant avec les réactifs de coloration de diagnostic in vitro utilisés en biologie
NF S98-116-1*NF EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : critical and semi-critical medical devices
NF S97-532:2002 Medical informatics - Messages concerning blood transfusion - Labile blood product delivery message.
NF EN ISO 10993-13:2010 Évaluation biologique des dispositifs médicaux - Partie 13 : identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
NF EN ISO 27269:2022 Informatique de santé - Résumé international du dossier médical du patient
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF S97-544-1:2012 Health informatics - Electronic health record communication - Part 1: reference model
NF S97-558-3:2008 Health informatics - Service architecture - Part 3 : computational viewpoint.
NF S97-543:1998 Informatique de santé - Message normalisé des Nations Unies - Coût et utilisation de ressources médicales (MEDRUC).
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
NF S97-531:2002 Medical informatics - Messages concerning blood transfusion - Nominative delivery message and report on nominative delivery message.
NF EN ISO 11238:2018 Informatique de santé - Identification des produits médicaux - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF X30-503:2011 Healthcare waste - Reduction of microbiological and mechanical risks from potentially infectious and other comparable healthcare waste by disinfection pretreatment appliances.
NF S97-518-10201:2006 Health informatics - Point-of-care medical device communication - Part 10201 : domain information model.
NF S97-540*NF EN 12435:2006 Health informatics - Expression of results of measurements in health sciences
NF EN ISO 13120:2019 Informatique de santé - Syntaxe de représentation du contenu des systèmes de classification des soins de santé - Langage de marquage de la classification (ClaML)
NF EN ISO 17664-1:2021 Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 1 : dispositifs médicaux critiques et semi-critiques
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
NF S91-224*NF EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
NF S97-544-2:2008 Health informatics - Electronic health record communication - Part 2 : archetypes interchange specification.

Liaoning Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB21/T 3683-2022 Regulations on Hygienic Management of Medical Waste in Medical and Health Institutions

AT-ON, Medical Bioinformatics

ONORM K 2202-1999 Medical informatics - Patient refferal
ONORM K 2203-1999 Medical informatics - Patient discharge
ONORM K 2020 Teil.1-1981 Freeze-drying of substances ofbiological origin for medical use; deflnitions
ONORM K 2020 Teil.2-1981 Freeze-drying of substances of biological origin for medical use; methods
OENORM EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2021)

European Committee for Standardization (CEN), Medical Bioinformatics

DD ENV 12967-1-1998 Medical Informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare Middleware Layer
DD ENV 12443-1999 Medical informatics - Healthcare Information Framework (HIF)
EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
DD ENV 1068-1993 Medical Informatics - Healthcare Information Interchange - Registration of Coding Schemes
EN ISO 21549-6:2008 Health informatics - Patient healthcard data - Part 6: Administrative data (ISO 21549-6:2008)
EN ISO 21549-5:2008 Health informatics - Patient healthcard data - Part 5: Identification data
DD ENV 12 381-1996 Health Care Informatics - Time Standards for Healthcare Specific Problems
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DD ENV 12538-1997 Medical Informatics - Messages for Patient Referral and Discharge
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 1041:1998 Information Supplied by the Manufacturer with Medical Devices
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
PD CEN/TS 15127-1-2005_ Health informatics - Testing of physiological measurement software - Part 1: General
PD CEN/TS 15127-1:2005 Health informatics - Testing of physiological measurement software - Part 1: General
DD ENV 13606-4-2000 Health Informatics - Electronic Healthcare Record Communication - Part 4: Messages for the Exchange of Information
EN ISO 12967-2:2020 Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO 12967-2:2020)
EN ISO 12967-2:2011 Health informatics - Service architecture - Part 2: Information viewpoint (ISO 12967-2:2009)
EN 475:1995 Medical Devices - Electrically-Generated Alarm Signals
DD ENV 12611-1997 Medical Informatics - Categorial Structure of Systems of Concepts - Medical Devices
DD ENV 12610-1997 Medical Informatics - Medicinal Product Identification
EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
EN ISO 11073-10201:2005 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model (ISO/IEEE 11073-10201:2004)
EN ISO 11073-30400:2012 Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet
PD CEN/TS 14271:2003 Health informatics - File exchange format for vital signs
EN ISO 11238:2012 Health 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 11238:2018 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
PD CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
EN ISO 11615:2012 Health 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 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

IEEE - The Institute of Electrical and Electronics Engineers@ Inc., Medical Bioinformatics

IEEE 11073-10207-2017 Health informatics - Point-of-care medical device communication - Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature
IEEE 11073-20702-2018 Health informatics - Point-of-care medical device communication - Part 20702: Medical Devices Communication Profile for Web Services
IEEE 11073-10207-2019 Health informatics - Personal health device communication - Part 10207: Domain information and service model for service-oriented point-ofcare medical device communication
IEEE 11073-20702-2016 Health informatics-Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
IEEE P11073-10201/D2.1.10-2018 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
IEEE P11073-10201/D2.1.9-2018 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
IEEE 11073-10201-2018 Health informatics-Point-of-care medical device communication Part 10201: Domain Information Model
IEEE P11073-10101/D9-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature
IEEE P11073-10101/D7-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature
IEEE P11073-10101/D5-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature

Tianjin Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB12/ 597-2015 Regulations on Medical Waste Treatment in Medical and Health Institutions

International Organization for Standardization (ISO), Medical Bioinformatics

ISO/TR 21089:2004 Health informatics - Trusted end-to-end information flows
ISO/TS 21089:2018 Health informatics - Trusted end-to-end information flows
ISO/TR 11633-1:2009 Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 21549-5:2008 Health informatics - Patient healthcard data - Part 5: Identification data
ISO 21549-6:2008 Health informatics - Patient healthcard data - Part 6: Administrative data
ISO 21549-5:2015 Health informatics - Patient healthcard data - Part 5: Identification data
ISO 19001:2002 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 12967-2:2020 Health informatics — Service architecture (HISA) — Part 2: Information viewpoint
ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
ISO/TS 11633-1:2019 Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO/TR 15223:1998 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14199:2015 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO/TR 11633-2:2009 Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 2: Implementation of an information security management system (ISMS)
ISO/TR 11633-2:2021 Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 2: Implementation of an information security management system (ISMS)
ISO/DIS 14199 Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
ISO/CD TS 5788:2023 Health informatics — Internet Healthcare Service Pattern
ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
ISO 13606-1:2008 Health informatics - Electronic health record communication - Part 1: Reference model
ISO/TS 18308:2004 Health informatics - Requirements for an electronic health record architecture
ISO/IEC CD TS 21419 Information Technology — Cross-Jurisdictional and societal aspects of implementation of biometric technologies — Use of biometrics for identity management in healthcare
ISO/IEEE 11073-10201:2004 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 13606-2:2008 Health informatics - Electronic health record communication - Part 2: Archetype interchange specification
ISO 18104:2003 Health informatics - Integration of a reference terminology model for nursing
ISO/CD TS 5777:2023 Health Informatics — The architecture of Internet healthcare service network
ISO/TS 19256:2016 Health informatics - Requirements for medicinal product dictionary systems for health care
ISO/TR 16056-2:2004 Health informatics - Interoperability of telehealth systems and networks - Part 2: Real-time systems
ISO 11238:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11238:2018 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO/CD 7405:2023 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO/TR 16056-1:2004 Health informatics - Interoperability of telehealth systems and networks - Part 1: Introduction and definitions

Institute of Electrical and Electronics Engineers (IEEE), Medical Bioinformatics

IEEE Std 11073-10207-2017 IEEE Health informatics--Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE P11073-10201/D2.1.10 October 2018 IEEE Draft Standard for Health Informatics - Point-of-Care Medical Device Communication - Domain Information Model
IEEE P1073.1.1.1/D04:2002 Draft Standard for Health Informatics Point-of-Care Medical Device Communication, Nomenclature DS5902
IEEE P1073.1.1.1/D05D:2002 Draft Standard for Health Informatics Point-of-Care Medical Device Communication, Nomenclature DS5902
IEEE Std P1073.1.2.1/D6 Unapproved IEEE Standard IEEE Draft Health Informatics - Point-Of-Care Medical Device Communications - Domain Information Model
IEEE P11073-10101/D1, June 2018 IEEE Draft Standard for Health Informatics—Point-of-Care Medical Device Communication—Part 10101: Nomenclature
IEEE Unapproved Draft Std P11073-00101/D03, Sep 20 Health Informatics - Point-Of-Care Medical Device Communication - Technical Report - Guidelines for the Use of RF Wireless Technology
IEEE Std 11073-20702-2016 IEEE Health informatics--Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
IEEE P1073.1.2.1/D06:2003 (Draft)Draft Health Informatics - Point-of-Care Medical Device Communications - Domain Information Model
IEEE P11073-10201/D2.19, September 2018 IEEE Draft Standard for Health Informatics - Point-of-Care Medical Device Communication - Domain Information Model
IEEE/ISO 11073-10207-2019 ISO/IEEE International Standard - Health informatics--Point-of-care medical device communication - Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
ISO/IEEE 11073-10207:2019(E) ISO/IEC/IEEE Health informatics--Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE P1073.3.3/D8, July 2003 IEEE Draft Standard for Health Informatics - Point-of-Care Medical Device Communication - Transport profile - IrDA based - Infrared Wireless
IEEE 1073.3.3-2004 IEEE Draft Standard for Health Informatics - Point-of-Care Medical Device Communication - Transport profile - IrDA based - Infrared Wireless

ZA-SANS, Medical Bioinformatics

SANS 18308:2007 Health informatics - Requirements for an electronic health record architecture
SANS 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

国家卫生计生委, Medical Bioinformatics

WS/T 517-2016 Basic functional specifications for primary medical and health information systems
WS 539-2017 Telemedicine information basic data set
WS/T 529-2016 Basic functional specifications of telemedicine information system
WS/T 546-2017 Interaction specifications between telemedicine information system and unified communications platform

American National Standards Institute （ANSI), Medical Bioinformatics

ANSI/ASTM E2017:1999 Guide for Amendments to Health Information
ANSI/AAMI ST81-2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
ANSI/ASTM E2085:2001 Guide on Security Framework for Healthcare Information
ANSI/ASTM E1762:1997 Guide for Electronic Authentication of Health Care Information
ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
ANSI/IEEE 11073-00101:2008 Guide for Health Informatics - Point-of-Care Medical Device Communication - Technical Report - Guidelines for the Use
ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ANSI/INCITS 284-2011 Information Technology - Identification Cards - Health Care Identification Cards
ANSI/ASTM E2084:2000 Specification for Authentication of Healthcare Information using Digital Signatures
ANSI/IEEE 11073-10201:2004 Standard for Health Informatics - Point-of-Care Medical Device Communication - Domain Information Model
ANSI P1073.1.2.1/D06-2003 Draft Health Informatics - Point-of-care medical device communications - Domain information model

North Atlantic Treaty Organization Standards Agency, Medical Bioinformatics

STANAG 2481-2001 MEDICAL INFORMATION COLLECTION AND REPORTING
STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS

Taiwan Provincial Standard of the People's Republic of China, Medical Bioinformatics

CNS 14232-1998 Health level seven (HL7)
CNS 14990-2006 Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied
CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

未注明发布机构, Medical Bioinformatics

DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN EN ISO 21549-2:2004 Medical Informatics – Patient Data on Healthcare Cards – Part 2: Common Elements
BS EN 475:1995(1999) Medical devices — Electrically - generated alarm signals
DIN EN ISO 21549-1:2004 Medical informatics – patient data on cards in healthcare – Part 1: General structure
DIN EN 475:1995 Medical devices IN Electrically generated alarm signals
DIN EN ISO 18113-4:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-3:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-1:2010 In vitro diagnostic medical devices Information provided by the manufacturer
DIN EN ISO 18113-5:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-2:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 21549-3:2004 Medical informatics – patient data on cards in healthcare – Part 3: Clinical data – core data set

国家药监局, Medical Bioinformatics

YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers
YY/T 0639-2019 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Shanghai Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB31/T 1249-2020 Medical Waste Hygienic Management Regulations
DB31/T 905-2015 Construction and operation specification of medical insurance information system

KR-KS, Medical Bioinformatics

KS X ISO 17113-2009 Health informatics－Exchange of information between healthcare information systems－Developement of messages
KS P ISO 20417-2022 Medical devices — Information to be supplied by the manufacturer
KS P ISO 19001-2017(2022) In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
KS P ISO 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
KS P ISO 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

RU-GOST R, Medical Bioinformatics

GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 56837-2015 Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Part 1. Requirements and risk analysis
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 14199-2016 Health informatics. Information models. Biomedical Research Integrated Do-main Group (BRIDG) Model
GOST R 52976-2008 Health informatics. First database structure of medical statistics of medical entity for electronic exchange of these data. General requirements
GOST 33275-2015 Biological medicine remedies for veterinary use. Vaccines fowl pox. Specifications
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R 57298-2016 Radiopharmaceutical medicinal products. General requirements for organization of production of radiopharmaceuticals in medical organizations
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 15223-2002 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied
GOST ISO/TS 22220-2013 Health informatics. Identification of subjects of health care
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
GOST R 57679-2017 Medicines for medical applications. Investigation bioequivalence of medications
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R 52978-2008 Health informatics. Database structure of medical entity for electronic exchange of these data. General requirements
GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
GOST R ISO 10993.13-1999 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices / Note: To be replaced by GOST R ISO 10993-13 (2009).
GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST R 56843-2015 Health informatics. Point-of-care medical device communication. Part 10201. Domain information model
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
GOST R 53930-2010 Medical-social expertise. Information support system of medical-social expertise. General provisions
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R 52979-2008 Health informatics. Database organization of policy of medical insurance for electronic data interchange. General requirements
GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods

Indonesia Standards, Medical Bioinformatics

SNI ISO 19001:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Korean Agency for Technology and Standards (KATS), Medical Bioinformatics

KS P ISO 19001:2010 In virto diagnostic medical devices－Information supplied by the manufacturer with in vitro gnostic reagents for staining in biology
KS X ISO TS 27527:2014 Health informatics — Provider identification
KS X ISO TS 27527:2017 Health informatics — Provider identification
KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS X ISO HL7 21731:2014 Health informatics — HL7 version 3 — Reference information model — Release 1
KS X ISO HL7 21731:2016 Health informatics — HL7 version 3 — Reference information model — Release 1
KS P ISO 19001:2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
KS P ISO 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS X ISO/IEEE 11073-10201:2015 Health informatics — Point-of-care medical device communications — Part 10201: Domain information model
KS X ISO/IEEE 11073-10201-2015(2020) Health informatics — Point-of-care medical device communications — Part 10201: Domain information model
KS X ISO/IEEE 11073-10101-2015(2020) Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature
KS P ISO 15223:2007 Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

Lithuanian Standards Office , Medical Bioinformatics

LST EN 1041-2008+A1-2014 Information supplied by the manufacturer of medical devices
LST EN 1041-2008 Information supplied by the manufacturer of medical devices
LST EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
LST L ENV 13609-2-2002 Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information
LST EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

IT-UNI, Medical Bioinformatics

UNI CEI EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer

中华人民共和国国家卫生和计划生育委员会, Medical Bioinformatics

WS/T 545-2017 Telemedicine information system technical specifications

Professional Standard - Medicine, Medical Bioinformatics

YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY/T 0639-2008 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
YY/T 1815-2022
YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical Bioinformatics

GB/T 42465-2023 Basic data set of traditional Chinese medicine information on human biological samples
GB/T 18773-2008 Environmental sanitation standard for incineration of medical treatment wastes
GB/T 18773-2002 Environmental sanitation standard for incineration of medical treatment wastes
GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices

农业农村部, Medical Bioinformatics

SC/T 9607-2018 Specification for medical records of aquatic mammals

VN-TCVN, Medical Bioinformatics

TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements

Canadian Standards Association (CSA), Medical Bioinformatics

CSA ISO/TS 18308:05-CAN/CSA:2005 Health informatics Requirements for an electronic health record architecture First Edition; ISO/TS 18308:2004

Japanese Industrial Standards Committee (JISC), Medical Bioinformatics

JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
JIS T 6001:2012 Evaluation of biocompatibility of medical devices used in dentistry
JIS T 6001:2021 Evaluation of biocompatibility of medical devices used in dentistry

Standard Association of Australia （SAA）, Medical Bioinformatics

AS 5023 Set:2006 Health supply chain messaging Set
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
AS ISO 10993.11:2002/Amdt 1:2005

ES-UNE, Medical Bioinformatics

UNE-EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
UNE-EN ISO 7405:2019 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

Professional Standard - Hygiene , Medical Bioinformatics

WS/T 363.16-2023 Health Information Data Meta Catalog Part 16: Drugs and Medical Devices
WS/T 364.16-2023 Health Information Data Element Value Field Code Part 16: Drugs and Medical Devices

Hubei Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB4211/T 12-2022 Hygienic management specification for temporary storage room of medical waste

卫生健康委员会, Medical Bioinformatics

WS/T 790.7-2021 Regional Health Information Platform Interaction Standard Part 7: Medical and Health Institution Registration Services
WS/T 790.8-2021 Regional Health Information Platform Interaction Standard Part 8: Medical and Health Personnel Registration Services

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Medical Bioinformatics

GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

Canadian General Standards Board （CGSB), Medical Bioinformatics

CAN/CGSB-43.125-2016 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical waste

ANSI - American National Standards Institute, Medical Bioinformatics

INCITS 284-2011 Information Technology - Identification Cards - Health Care Identification Cards

North Atlantic Treaty Organization Military Agency for Standardization (NATO-MAS), Medical Bioinformatics

STANAG 2562-2020 MEDICAL COMMUNICATIONS AND INFORMATION SYSTEMS (MedCIS) - AJMedP-5 EDITION B

Guangdong Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB4403/T 261-2022 Regional medical operation management information data specification

GOSTR, Medical Bioinformatics

GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST R 53930-2019 Medical-social expertise. Information support system for medical-social expertise. Basic provisions
GOST R ISO 7405-2011 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
GOST 34310-2017 Biological medicine remedies for veterinary use. Methods for determination of mertiolyt, phenol, formaldehyde
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

TH-TISI, Medical Bioinformatics

TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices

Yunnan Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB5305/T 19.36-2019 Baoshan City Information Huimin Project Comprehensive Standard Part 36: Technical Standards for Regional Medical and Health Information Platform

Shandong Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB37/T 4221.6-2020 Government Information Resource Dataset Population Part 6: Medical Insurance Information

American Society for Testing and Materials (ASTM), Medical Bioinformatics

ASTM E1762-95(2003) Standard Guide for Electronic Authentication of Health Care Information
ASTM E2085-00a Standard Guide on Security Framework for Healthcare Information
ASTM E2145-01 Standard Practice for Modeling in Health Informatics

CH-SNV, Medical Bioinformatics

SN EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
SN EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

PL-PKN, Medical Bioinformatics

PN-EN ISO 20417-2021-10 E Medical devices -- Information to be supplied by the manufacturer (ISO 20417:2021)

国家市场监督管理总局、中国国家标准化管理委员会, Medical Bioinformatics

GB/T 39725-2020 Information security technology—Guide for health data security

司法部, Medical Bioinformatics

SF/T 0043-2019 Technical specifications for smart detoxification medical management information system

Jiangxi Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB36/T 1687-2022 Management specification for secondary biosafety laboratories in medical and health institutions

IN-BIS, Medical Bioinformatics

IS 12572 Pt.8-1988

Inner Mongolia Provincial Standard of the People's Republic of China, Medical Bioinformatics

DB15/T 961-2016 Pharmaceutical logistics information management specification