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IVD Network

IVD Network, Total:498 items.

In the international standard classification, IVD Network involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Medical equipment, Hospital equipment, Diagnostic, maintenance and test equipment, Company organization and management, Veterinary medicine, Vocabularies, Microbiology, Farming and forestry, Labour. Employment, Occupational safety. Industrial hygiene, Power transmission and distribution networks, Corrosion of metals, Packaging and distribution of goods in general, Installations in buildings, Textile fibres, Products of the textile industry, Packaging materials and accessories, Construction industry, Air quality, Road vehicle systems, Applications of information technology, Alarm and warning systems, Telecommunication systems.


AT-ON, IVD Network

  • ONORM EN 376-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing
  • ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use
  • OENORM EN ISO 18113-2:2021 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)
  • OENORM EN ISO 18113-3:2021 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)
  • OENORM EN ISO 18113-4:2021 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)
  • ONORM EN 829-1996 In vitro diagnostic systems-Transport packages for medical and biological specimens-Requirements,test
  • ONR CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
  • OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • OENORM EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021)

British Standards Institution (BSI), IVD Network

  • BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
  • BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
  • BS EN ISO 23640:2015 Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
  • BS EN ISO 18113-4:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
  • BS EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
  • BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
  • BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
  • BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
  • BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
  • BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • BS EN 13612:2002(2003) Performance evaluation of in vitro diagnostic medical devices
  • BS EN 1658:1997 Requirements for marking of in vitro diagnostic instruments
  • BS EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
  • 21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use
  • 21/30416041 DC BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 4. In vitro diagnostic reagents for self-testing
  • 21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional use
  • 21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing
  • 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 EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
  • BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
  • BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • BS EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  • BS EN 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
  • BS EN 12322:1999+A1:2001 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
  • BS ISO 21474-2:2022 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification
  • BS EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated RNA
  • PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
  • BS ISO 14229-5:2013 Road vehicles. Unified diagnostic services (UDS). Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • BS PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
  • 20/30424657 DC BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans
  • BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
  • BS EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
  • BS EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteins
  • BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
  • BS EN 12286:1999(2001) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
  • BS EN 12286:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
  • BS EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated genomic DNA
  • PD CEN/TS 17747:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins
  • BS ISO 14229-3:2012 Road vehicles. Unified diagnostic services (UDS). Unified diagnostic services on CAN implementation (UDSonCAN)
  • BS EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
  • BS ISO 15031-6:2010 Road vehicles. Communication between vehicle and external equipment for emissions-related diagnostics. Diagnostic trouble code definitions
  • BS ISO 14229-5:2022 Tracked Changes. Road vehicles. Unified diagnostic services (UDS). Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • PD CEN/TS 17811:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
  • PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated cellular RNA
  • BS EN ISO 20184-3:2021 Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated DNA
  • PD CEN/TS 17688-2:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated proteins
  • BS ISO 15031-5:2011 Road vehicles. Communication between vehicle and external equipment for emissions-related diagnostics. Emissions-related diagnostic services
  • BS EN ISO 6717:2021 Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
  • BS ISO 15765-5:2021 Road vehicles. Diagnostic communication over Controller Area Network (DoCAN). Specification for an in-vehicle network connected to the diagnostic link connector
  • BS EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • BS PD CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins
  • BS EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
  • BS EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements
  • BS EN ISO 15197:2013 In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
  • BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
  • PD CEN/TS 17688-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated genomic DNA
  • 21/30421396 DC BS EN ISO 4307. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
  • BS EN ISO 4307:2021 Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
  • BS ISO 15031-3:2016 Road vehicles. Communication between vehicle and external equipment for emissions-related diagnostics. Diagnostic connector and related electrical circuits: Specification and use

Korean Agency for Technology and Standards (KATS), IVD Network

  • KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P SIO 18113-2-2012 In vitro diagnostic medical devices--Information supplied by the manufacturer (labelling)--Part 2:In vitro diagnostic reagents for professional use
  • KS P ISO 18113-4-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
  • KS P ISO 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
  • KS P ISO 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
  • KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
  • KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
  • KS P 1800-2013 Protocol for evaluation of matrix effects in in-vitro diagnostic test
  • KS P 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
  • KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacture
  • 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 1977-2018 Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
  • KS P 1975-2018 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
  • KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
  • KS R ISO 14229-5:2018 Road vehicles — Unified diagnostic services (UDS) — Part 5: Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • KS P 0108-2017 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ─ Laboratory quality practice guide
  • KS P ISO 15197:2010 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • KS P ISO 16256:2017 Clinical laboratory testing and in vitro diagnostic test systems ─ Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

KR-KS, IVD Network

  • KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
  • KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
  • 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 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
  • KS R ISO 14229-5-2018 Road vehicles — Unified diagnostic services (UDS) — Part 5: Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • KS P 0107-2017(2022) Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ─ general requirements, terms and definitions
  • KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
  • KS P ISO 16256-2017 Clinical laboratory testing and in vitro diagnostic test systems ─ Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

International Organization for Standardization (ISO), IVD Network

  • ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
  • ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
  • ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
  • ISO 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
  • ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
  • ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
  • ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
  • ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
  • ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
  • ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
  • ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
  • ISO 14229-5:2013 Road vehicles.Unified diagnostic services (UDS).Part 5: Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • ISO 15765-3:2004 Road vehicles - Diagnostics on Controller Area Networks (CAN) - Part 3: Implementation of unified diagnostic services (UDS on CAN)
  • ISO/IEEE 11073-10408:2010 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
  • ISO 14229-5:2022 Road vehicles — Unified diagnostic services (UDS) — Part 5: Unified diagnostic services on Internet Protocol implementation (UDSonIP)
  • ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
  • ISO 20184-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
  • ISO 15765-5:2021 Road vehicles — Diagnostic communication over Controller Area Network (DoCAN) — Part 5: Specification for an in-vehicle network connected to the diagnostic link connector
  • ISO/FDIS 15765-5:2023 Road vehicles — Diagnostic communication over Controller Area Network (DoCAN) — Part 5: Specification for an in-vehicle network connected to the diagnostic link connector
  • ISO/DIS 15765-5 Road vehicles — Diagnostic communication over Controller Area Network (DoCAN) — Part 5: Specification for an in-vehicle network connected to the diagnostic link connector
  • ISO 15765-5:2023 Road vehicles — Diagnostic communication over Controller Area Network (DoCAN) — Part 5: Specification for an in-vehicle network connected to the diagnostic link connector
  • ISO 15031-6:2010 Road vehicles - Communication between vehicle and external equipment for emissions-related diagnostics - Part 6: Diagnostic trouble code definitions
  • ISO 15031-6:2015 Road vehicles - Communication between vehicle and external equipment for emissions-related diagnostics - Part 6: Diagnostic trouble code definitions
  • ISO 15031-6:2005 Road vehicles - Communication between vehicle and external equipment for emissions-related diagnostics - Part 6: Diagnostic trouble code definitions
  • ISO 15197:2013 In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA
  • ISO 14229-3:2012 Road vehicles - Unified diagnostic services (UDS) - Part 3: Unified diagnostic services on CAN implementation (UDSonCAN)

ES-UNE, IVD Network

  • UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
  • UNE-EN ISO 6717:2022 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
  • UNE-EN ISO 4307:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
  • UNE-CEN/TS 17747:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (Endorsed by Asociación Española de Normalización in June of 2022.)
  • UNE-EN ISO 20184-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
  • UNE-EN ISO 20184-3:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

Association Francaise de Normalisation, IVD Network

  • NF EN ISO 23640:2015 Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
  • NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • NF S92-017:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUALS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE. (EUROPEAN STANDARD EN 592).
  • NF S92-016:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIRMENTS FOR USER MANUELS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 591).
  • NF S92-010:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 375).
  • NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
  • 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 S92-031:1996 In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.
  • 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 S92-010-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.
  • NF S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
  • NF S92-010-4*NF EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing
  • NF S92-010-5*NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing
  • NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
  • NF EN 13612:2002 Évaluation des performances des dispositifs médicaux de diagnostic in vitro
  • NF S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
  • NF S92-010-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use.
  • NF S92-010-3*NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use
  • NF EN ISO 18113-3:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3 : instruments de diagnostic in vitro à usage professionnel
  • NF EN ISO 18113-2:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2 : réactifs de diagnostic in vitro à usage professionnel
  • NF S92-010-2*NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
  • NF EN ISO 18113-5:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : instruments de diagnostic in vitro pour auto-tests
  • NF EN ISO 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
  • NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • NF EN 13532:2002 Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test
  • NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
  • NF EN 14136:2004 Utilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performances des procédures de diagnostic in vitro
  • NF S92-050*NF EN 1659:1997 In vitro diagnostic systems. Culture media for microbiology. Terms and definitions.
  • NF EN 1659:1997 Systèmes de diagnostic in vitro - Milieux de culture de microbiologie - Termes et définitions.
  • NF S92-041*NF EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  • NF EN 13641:2002 Élimination ou réduction du risque d'infection relatif aux réactifs de diagnostic in vitro
  • NF S92-036:2004 In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans.
  • NF S92-036*NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
  • NF S92-035*NF EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • NF S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
  • AC P16-635:2011 Référentiel de Diagnostic des installations d'Assainissement Non Collectif
  • NF S92-076*NF EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
  • NF EN 12322/A1:2002 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
  • NF EN ISO 4307:2021 Analyse de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour la salive - ADN humain extrait
  • NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
  • NF EN 12322:1999 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture.
  • NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
  • NF S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
  • NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
  • NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang
  • NF S92-051/A1*NF EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  • NF S92-051*NF EN 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.
  • NF ISO 21474-2:2022 Dispositifs médicaux de diagnostic in vitro - Tests moléculaires multiplex pour les acides nucléiques - Partie 2 : validation et vérification
  • NF C74-390:1985 Electromedical equipment. Diagnostic equipment from biopotentials other than cardiographic (ecg). Requirements for safety and operation for such equipment.
  • NF S92-026:2004 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
  • NF S92-026:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • NF S92-070-3*NF EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3 : isolated DNA
  • NF S92-070-1*NF EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1 : isolated RNA
  • NF EN ISO 20184-3:2021 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 3 : ADN extrait
  • NF S92-012*NF EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

German Institute for Standardization, IVD Network

  • DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
  • DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
  • DIN EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
  • DIN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
  • DIN EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
  • DIN EN ISO 19001:2013-07 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this stan...
  • DIN EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
  • DIN EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013
  • DIN EN 1659:1997 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions; German version EN 1659:1996
  • 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 18113-4:2013 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
  • DIN EN 1659:1997-01 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions; German version EN 1659:1996
  • DIN EN ISO 18113-3:2013 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
  • DIN EN ISO 18113-5:2013 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
  • DIN EN 13641:2002-08 Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts
  • DIN EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
  • DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
  • DIN EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans; German version EN 14254:2004
  • DIN EN ISO 18113-2:2013 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
  • DIN EN ISO 6717:2020 In vitro diagnostic medical devices - Single-use containers for the collection of specimens, other than blood, from humans (ISO/DIS 6717:2020); German and English version prEN ISO 6717:2020
  • DIN CEN/TS 17626:2022-01 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA; German version CEN/TS 17626:2021
  • DIN EN ISO 6717:2021-12 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021
  • DIN EN 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
  • DIN EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
  • DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
  • DIN CEN/TS 17747:2022-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins; German version CEN/TS 17747:2022
  • DIN EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
  • DIN CEN/TS 17811:2022-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA; German version CEN/TS 17811:2022
  • DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
  • DIN EN ISO 20184-1:2019-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018); German version EN ISO 20184-1:2018
  • DIN EN ISO 20184-3:2021-11 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021); German version EN ISO 20184-3:2021
  • DIN EN ISO 4307:2022-02 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021); German version EN ISO 4307:2021
  • DIN EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
  • DIN EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021); German and English version prEN ISO 4307:2021
  • DIN EN 18000-2:2023-10 Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023 / Note: Date of issue 2023-09-08

国家药品监督管理局, IVD Network

  • YY/T 1579-2018 In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation

BE-NBN, IVD Network

  • NBN EN 592-1995 In vitro diagnostic systems - Requirements for user manual for in vitro diagnostic instruments for home use
  • NBN EN 591-1995 In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
  • NBN-EN 376-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
  • NBN C 74-336-1990

European Committee for Standardization (CEN), IVD Network

  • EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
  • EN 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
  • EN 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
  • EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
  • prEN 928-1992 In vitro diagnostic systems; guidance on the application of EN 29001/EN 46001 and EN 29002/EN 46002 for the in vitro diagnostics industry
  • EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
  • CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
  • EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
  • EN 928:1995 In Vitro Diagnostic Systems - Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in Vitro Diagnostic Medical Devices
  • EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
  • EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
  • EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
  • EN ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use [Superseded: CEN EN 591]
  • EN ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing [Superseded: CEN EN 592]
  • prEN ISO 18113-2:2021 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)
  • prEN ISO 18113-3:2021 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)
  • FprEN ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
  • FprEN ISO 18113-3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
  • prEN ISO 18113-5:2021 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)
  • prEN ISO 18113-4:2021 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)
  • FprEN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
  • FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
  • CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
  • EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • prEN 591-1991 In-vitro diagnostic systems; requirements for user manual of in-vitro diagnostic instruments for professional use
  • EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
  • EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
  • EN 376:2002 Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing
  • EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
  • CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
  • EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
  • EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
  • EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
  • prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests
  • FprCEN/TS 17747-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
  • prCEN ISO/TS 18702 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
  • CEN/TS 17747:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
  • prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
  • CEN/TS 17811:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
  • prEN ISO 18704 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
  • EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
  • EN ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003
  • EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
  • EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus

Danish Standards Foundation, IVD Network

  • DS/EN 376:1993 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
  • DS/EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
  • DS/EN 591:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or professional use
  • DS/EN 592:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or home use
  • 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 1659:1997 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
  • DS/ISO 6717:2021 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood
  • DS/CEN/TS 17626:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for human specimen – Isolated microbiome DNA
  • DS/EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  • DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  • DS/ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA
  • DS/ISO 20184-3:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA
  • DS/ISO 15765-5:2021 Road vehicles – Diagnostic communication over Controller Area Network (DoCAN) – Part 5: Specification for an in-vehicle network connected to the diagnostic link connector

AENOR, IVD Network

  • UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
  • UNE-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
  • UNE-EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
  • UNE-EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
  • UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
  • UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
  • UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
  • UNE-EN 1659:1997 IN VITRO DIAGNOSTIC SYSTEMS. CULTURE MEDIA FOR MICROBIOLOGY. TERMS AND DEFINITIONS.
  • UNE-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • UNE-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
  • UNE-EN 12322:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. CULTURE MEDIA FOR MICROBIOLOGY. PERFORMANCE CRITERIA FOR CULTURE MEDIA.
  • UNE-EN 12322/A1:2002 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.
  • UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
  • UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

Professional Standard - Hygiene , IVD Network

  • WS/T 252-2005 Labeling of In Vitro Diagnosis Products
  • WS 290-2008 Diagnostic criteria for leptospirosis
  • WS/T 513-2016 Diagnosis of genital chlamydia trachomatis infection
  • WS/T 253-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials
  • WS/T 254-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Presentation of reference measurement procedures

US-FCR, IVD Network

RU-GOST R, IVD Network

  • 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 51352-2013 In vitro diagnostic medical devices. Test methods
  • GOST R ISO 18113-5-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
  • GOST R ISO 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
  • GOST R ISO 18113-4-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
  • GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
  • GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
  • GOST R 57003-2016 Diagnostics in oncology. Diagnostic algorithms. Solid intrathoracic tumors. Laboratory stage
  • GOST EN 14136-2016 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
  • GOST R ISO 15197-2015 In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus

Professional Standard - Medicine, IVD Network

  • YY/T 1244-2014 Purified water for in vitro diagnostic reagents
  • YY/T 1153-2009 DNA microarray for in vitro diagnostics
  • 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 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
  • YY/T 1151-2009 Protein microarray for in vitro diagnostics
  • YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
  • YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
  • YY/T 0202-2004 Medical diagnostic X-ray device for tomography

Professional Standard - Agriculture, IVD Network

  • 162药典 三部-2015 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 183药典 三部-2020 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 163药典 三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
  • 136药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum antibody diagnostic kit (enzyme-linked immunoassay)
  • 179药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 160药典 三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 137药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis rapid plasma reagin diagnostic reagents
  • 180药典 三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 161药典 三部-2015 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 134药典 三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis C virus antibody diagnostic kit (enzyme-linked immunoassay)
  • 164药典 三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
  • 181药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • 135药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnostic human immunodeficiency virus antibody diagnostic kit (enzyme-linked immunoassay)
  • 138药典 三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
  • 178药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
  • 159药典 三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
  • 133药典 三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
  • NY/T 553-2002 Diagnostic techniques for avian mycoplasmosis (mycoplasma gallisepticum)
  • NY/SY 155-2000 Toxoplasma diagnostic technical regulations
  • 165药典 三部-2015 Monograph IV In Vitro Diagnostic Anti-A Anti-B Blood Typing Reagents (Monoclonal Antibodies)
  • 184药典 三部-2020 Monograph IV In Vitro Diagnostic Anti-A Anti-B Blood Typing Reagents (Monoclonal Antibodies)
  • NY/T 1186-2017 Diagnostic techniques for mycoplasmal pneumonia of swine
  • NY/T 562-2015 Diagnostic techniques for animal chlamydiosis
  • NY/T 562-2002 Diagnostic techniques for animal chlamydiosis
  • NY/T 1186-2006 Diagnostic techniques for swine mycoplasmal pneumonia
  • NY/SY 182-2000 Chlamydiosis diagnosis technical regulations
  • NY/T 1247-2006 Diagnostic technique for avian reticuloendotheliosis
  • 139药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnostic anti-A anti-B blood typing reagent (monoclonal antibody)
  • 92兽药产品说明书范本第三册-2013 Instructions for freeze-dried complement of diagnostic products
  • NY/SY 175-2000 Diagnosis technical rules for chicken mycoplasma disease
  • 140药典 三部-2010 Chapter Ⅳ In vitro diagnostic anti-A and anti-B blood typing reagents (human serum)
  • 105兽药典 三部-2015 Text Contents Diagnostic Products Freeze-dried Complement
  • NY/T 1953-2010 Diagnostic technique for Mycoplasma suis(Eperythrozoon suis)
  • 177药典 三部-2020 Monograph III In Vivo Diagnosis of Sikh Test-like Toxins
  • 158药典 三部-2015 Monograph III In Vivo Diagnosis of Sikh Test-like Toxins
  • 121兽药产品说明书范本第三册-2013 Instructions for Diagnostic Products Fluorescent Antibody to CSFV

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, IVD Network

  • GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
  • GB/T 29791.3-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use
  • GB/T 29791.4-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
  • GB/T 29791.5-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting
  • GB/T 29791.2-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use
  • GB/T 32945-2016 In Vitro Detection of Bovine Tuberculosis Diagnosis Interferon-γ Method
  • GBZ 288-2017 Diagnosis of ocular (cornea, lens, retina) damage from occupational lasers
  • GB/T 19634-2005 In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing
  • GB 8280-2000 Diagnostic criteria and principles of management for acute radiation sickness from external exposure
  • GB 8281-2000 Diagnostic criteria and principles of management for chronic radiation sickness from external exposure
  • GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
  • GB 16388-1996 Diagnostic criteria and principles of management for subacute radiation sickness from external exposure
  • GB 16389-1996 Diagnostic criteria and principles of management for external radiation bone injuries
  • GB/T 19634-2005(XG1-2006) In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing AMD 1
  • GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1: Isolated RNA

国家药监局, IVD Network

  • YY/T 0639-2019 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • YY/T 1652-2019 General technical requirements for quality control materials for in vitro diagnostic reagents
  • YY/T 1709-2020 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic reagents
  • YY/T 1789.6-2023 In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
  • YY/T 1789.1-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 1: Precision
  • YY/T 1789.2-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy
  • YY/T 1789.5-2023 Methods for performance evaluation of in vitro diagnostic test systems Part 5: Analytical specificity
  • YY/T 1789.3-2022 In vitro diagnostic testing system performance evaluation methods Part 3: Detection limit and quantitation limit

Group Standards of the People's Republic of China, IVD Network

  • T/NAHIEM 36-2021 In-vitro diagnostic management (distribution) enterprise group standards
  • T/ZMDS 40001-2021 Guidelines for values assignment of calibrator of IVD
  • T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
  • T/CI 018-2022 Technical Guidelines on Canine Rapid Diagnosis In Vitro (Fluorescence Immunochromatography)
  • T/CI 019-2022 Technical Guidelines on Feline Rapid Diagnosis In Vitro (Fluorescence Immunochromatography)
  • T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents
  • T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing(POCT)
  • T/ZS 0275-2022 Technical specification for pre diagnosis of urban drainage network
  • T/CECS 1029-2022 Technical specification for quality diagnosis and evaluation of external thermal insulation system of building exterior wall
  • T/CIPR 118-2023 Valve remote fault diagnosis system based on Internet of Things technology

GOSTR, IVD Network

  • GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
  • GOST R EN 592-2010 Instructions for use for in vitro diagnostic instruments for self-testing
  • GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing
  • GOST R EN 13641-2010 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  • GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
  • GOST R EN 12322-2010 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
  • GOST ISO 15197-2011 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

Society of Automotive Engineers (SAE), IVD Network

未注明发布机构, IVD Network

  • DIN EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
  • DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use
  • 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
  • BS EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
  • DIN EN 12322 Ber-1:2001 In vitro diagnostics – culture media for microbiology – performance criteria for culture media
  • DIN EN 376:2002 Provision of information by the manufacturer of reagents for in-vitro diagnostic tests for self-use
  • DIN EN 14252:2004 In-vitro diagnostics – disposable vessels for human specimens with the exception of blood samples; German version EN 14254:2004
  • DIN EN ISO 15197:2004 Test systems for in vitro diagnostics – requirements for blood glucose measuring systems for self-use in diabetes mellitus
  • BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
  • BS EN 928:1996(1999) Guidance on the Application ofEN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
  • DIN EN ISO 4307:2022 Molecular analytical in vitro diagnostic procedures – Specifications for pre-analytical processes for saliva – Isolated human DNA

CEN - European Committee for Standardization, IVD Network

  • EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
  • EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
  • PD CEN/TS 17305:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
  • EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
  • EN 12287:1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials

Lithuanian Standards Office , IVD Network

  • LST EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
  • LST EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
  • LST EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
  • LST EN 1659-2001 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
  • LST EN 12322-2000 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  • LST CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA

SAE - SAE International, IVD Network

Professional Standard - Goods and Materials, IVD Network

  • WB/T 1115-2021 Specification for in vitro diagnostic reagent temperature control logistics service

国家发展和改革委员会, IVD Network

  • WB/T 1116-2020 In vitro diagnostic reagent temperature control logistics service specifications

Jiangsu Provincial Standard of the People's Republic of China, IVD Network

  • DB32/T 4000-2021 Bovine tuberculosis diagnostic technology (γ-interferon in vitro ELISA method)
  • DB32/T 1771-2011 Diagnosis technique of swine mycoplasma pneumonia

中华人民共和国国家卫生和计划生育委员会, IVD Network

  • WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
  • WS/T 568-2017 Diagnosis of extraintestinal abscess in amoebiasis
  • GBZ 105-2002 Diagnostic criteria for chronic radiation sickness from external exposure
  • GBZ 104-2002 Diagnostic criteria for acute radiation sickness from external exposure
  • GBZ 100-2002 Diagnostic Criteria for Radiation Bone Injury from External Exposure (Abolished)
  • GBZ 105-2017 Diagnosis of chronic radiation sickness from occupational external exposure (replaces GBZ 105-2002)

Occupational Health Standard of the People's Republic of China, IVD Network

  • GBZ(卫生) 100-2010 Diagnostic criteria for external radiation bone injury
  • GBZ 100-2010 Diagnostic criteria for external radiation bone injury
  • GBZ 99-2002 Diagnostic criteria for subacute radiation sickness from external exposure

Professional Standard - Aquaculture, IVD Network

  • SC/T 7204.1-2007 Diagnostic Protocols for Taura Syndrome of Penaeid Shrimp-Part 1: Gross Signs Method

Professional Standard - Electricity, IVD Network

  • DL/T 664-2008 Application rules of infrated diagnosis for live electrical equipment
  • DL/T 664-2016 Application specification for infrared diagnosis of live equipment
  • DL/T 1532-2016 Technical guide for corrosion diagnosis of grounding grid
  • DL/T 664-1999 Technical guide for infrared diagnosis of alive equipment
  • DL/T 345-2010 Charged device technology application guidelines for UV diagnostics
  • DL/T 345-2019 Guidelines for the application of ultraviolet diagnostic technology for live equipment

US-CFR-file, IVD Network

  • CFR 21-801.119-2013 Food and Drugs. Part801:Labeling. Section801.119:In vitro diagnostic products.

Shanxi Provincial Standard of the People's Republic of China, IVD Network

  • DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

Shandong Provincial Standard of the People's Republic of China, IVD Network

CH-SNV, IVD Network

  • SN EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

PT-IPQ, IVD Network

  • NP EN 12286-2000 In vitro diagnostic medical devices Measurement of quantities in samples of boilogical origin Presentation of reference measurement procedures

IX-EU/EC, IVD Network

  • 98/79/EC-1998 Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
  • COM(95)/C 172/02-1995 Proposal for a European Parliament and Council Directive on in Vitro Diagnostic Medical Devices

Japanese Industrial Standards Committee (JISC), IVD Network

  • JIS L 1918:2005 Testing for skin primary irritation on textile products-in vitro human skin model method
  • JIS L 1918:2011 Testing for skin primary irritation on textile products -- in vitro human skin model method
  • JIS Z 4924:1995 Phantoms for magnetic resonance equipment for medical diagnosis
  • JIS Z 4924:2016 Phantoms for magnetic resonance equipment for medical diagnosis

国家市场监督管理总局、中国国家标准化管理委员会, IVD Network

  • GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

石家庄市市场监督管理局, IVD Network

  • DB1301/T 424-2022 Technical requirements for sample collection of gamma-interferon method for in vitro detection of bovine tuberculosis diagnosis

IT-UNI, IVD Network

  • UNI CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
  • UNI EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA

农业农村部, IVD Network

  • NY/T 1247-2022 Diagnostic technology for avian reticuloendothelial hyperplasia
  • NY/T 4035-2021 Diagnostic technology for Mycoplasma synoviae infection in chickens
  • NY/T 3191-2018 Dairy cow ketosis diagnosis and group risk monitoring technology

Hubei Provincial Standard of the People's Republic of China, IVD Network

Taiwan Provincial Standard of the People's Republic of China, IVD Network

  • CNS 10668-1983 Mono Tank X-ray Units for Diagnostic Use
  • CNS 15035-2006 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Indonesia Standards, IVD Network

  • SNI ISO 15197:2009 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Canadian Standards Association (CSA), IVD Network

  • CSA ISO 15197-05-CAN/CSA:2005 Syst鑝es d'essais de diagnostic in vitro ?Exigences relatives aux syst鑝es d'autosurveillance de la glyc閙ie destin閟 ?la prise en charge du diab鑤e sucr镻remi鑢e 閐ition

工业和信息化部, IVD Network

  • YD/T 2277-2011 Access network technology requirements Passive Optical Network (PON) optical link monitoring and diagnosis

CU-NC, IVD Network

  • NC 57-94-1-1986 Clinical Methods and Aids. Heart-Broth Culture Media. Quality Specifications

Jilin Provincial Standard of the People's Republic of China, IVD Network

  • DB22/T 3473-2023 Etiological diagnosis technology of bovine respiratory syncytial disease




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