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In vitro diagnostic medical services

In vitro diagnostic medical services, Total:370 items.

In the international standard classification, In vitro diagnostic medical services involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Medical equipment, Applications of information technology, Microbiology, Pipeline components and pipelines, Packaging materials and accessories, Company organization and management, Quality, Electricity. Magnetism. Electrical and magnetic measurements, Electromagnetic compatibility (EMC), Electrical and electronic testing, Industrial automation systems.

British Standards Institution (BSI), In vitro diagnostic medical services

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 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 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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
DD ENV 12539-1998 Medical informatics. Request and report messages for diagnostic service departments
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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
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
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 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
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 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
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 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 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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 EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
21/30415510 DC BS ISO 21474-2. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 2. Validation and verification
BS ISO 21474-1:2020 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
BS EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
BS EN IEC 61010-2-101:2022+A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Safety requirements for in vitro diagnostic (IVD) medical equipment
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
BS EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
21/30416029 DC BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 1. Terms, definitions, and general requirements
BS ISO 21151:2020 In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
19/30361173 DC BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 1. Terminology and general requirements for nucleic acid quality evaluation
BS EN 61010-2-101:2017 Tracked Changes. Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment
BS EN ISO 17511:2021 Tracked Changes. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
19/30378309 DC BS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Korean Agency for Technology and Standards (KATS), In vitro diagnostic medical services

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 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 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 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P SIO 18113-1-2012 In vitro diagnostic medical devices--Information supplied by the manufacturer(labelling)--Part 1：Terms, definitions and general requirements
KS P ISO 18113-1:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 1: Terms, definitions and general requirements
KS P ISO 18113-1:2012 In vitro diagnostic medical devices-Information supplied by the manufacturer(labelling)-Part 1:Terms, definitions and general requirements
KS P ISO 17511:2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
KS P ISO 17511-2010(2016) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values assigned to calibrators and control materials
KS P ISO 17511:2010 In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values assigned to calibrators and control materials
KS P ISO 18153-2010(2016) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater
KS P ISO 15193-2014(2019) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
KS P ISO 18153-2010(2021) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater
KS P ISO 18153:2010 In vitro diagnostic medical devices-Measurement of quantities in biological samples-Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

KR-KS, In vitro diagnostic medical services

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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 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 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
KS P ISO 18113-1-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 1: Terms, definitions and general requirements
KS P ISO 17511-2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

International Organization for Standardization (ISO), In vitro diagnostic medical services

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 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO/IEEE 11073-10408:2010 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
ISO/IEEE 11073-10415:2010 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
ISO/IEEE 11073-10417:2010 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ISO/IEEE 11073-10420:2012 Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer
ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO 18113-1:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
ISO/IEEE 11073-20601:2010 Health informatics - Point-of-care medical device communication - Part 20601: Application profile - Optimized exchange protocol
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO/IEEE 11073-10471:2010 Health informatics - Point-of-care medical device communication - Part 10471: Device specialization - Independant living activity hub
ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

German Institute for Standardization, In vitro diagnostic medical services

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 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 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 18113-2:2013-01 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 18113-1:2021-09 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 18113-3:2021-09 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 18113-3:2013-01 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 18113-5:2021-09 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 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 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 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
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 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 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 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 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 13612:2002 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
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 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 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 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 6717:2021 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 ISO 15193:2009-10 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009
DIN EN ISO 17511:2019 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019); German and English version prEN ISO 17511:2019
DIN EN ISO 17511:2021-11 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
DIN EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN EN 61010-2-101:2003 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified); German version EN 61010-2-101:2002
DIN EN ISO 15194:2009-10 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009
DIN EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

ES-UNE, In vitro diagnostic medical services

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 17511:2022 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
UNE-EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (Endorsed by AENOR in June of 2013.)
UNE-EN 61010-2-101:2018 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN IEC 61010-2-101:2023 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN IEC 61010-2-101:2023/A11:2023 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

Association Francaise de Normalisation, In vitro diagnostic medical services

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 EN 13612:2002 Évaluation des performances des dispositifs médicaux de diagnostic in vitro
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 S92-040*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 S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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 S92-010-2:2010 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 S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
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 EN 12322:1999 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture.
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/A1:2002 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
NF S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
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 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 S97-518-10415*NF EN ISO 11073-10415:2011 Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.
NF S92-010-1:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements.
NF S92-010-1*NF EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements
NF EN ISO 18113-1:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1 : termes, définitions et exigences générales
NF S92-021*NF EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
NF EN IEC 61326-2-6:2021 Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6 : exigences particulières - Matériel médical de diagnostic in vitro (IVD)
NF C46-050-2-6*NF EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
NF C46-050-2-6*NF EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
NF S92-020*NF EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
NF S92-019*NF EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
NF S92-080:2020 In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
NF S92-021*NF EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
NF ISO 21151:2020 Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux protocoles d'harmonisation internationaux établissant la traçabilité métrologique des valeurs affectées aux étalons et aux échantillons humains
NF EN ISO 17511:2021 Dispositifs médicaux de diagnostic in vitro - Exigences pour l'établissement d'une traçabilité métrologique des valeurs attribuées aux étalons, aux matériaux de contrôle de la justesse et aux échantillons humains
NF EN IEC 61010-2-101/A11:2022 Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
NF EN IEC 61010-2-101:2022 Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101 : exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
NF C42-020-2-101*NF EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101 : particular requirements for in vitro diagnostic (IVD) medical equipment
NF S92-022*NF EN ISO 18153:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials.
NF EN ISO 15193:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence
NF EN ISO 15194:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les échantillons d'origine biologique - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée

国家药品监督管理局, In vitro diagnostic medical services

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

European Committee for Standardization (CEN), In vitro diagnostic medical services

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 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
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 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
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)
DD ENV 12539-1997 Medical Informatics - Request and Report Messages for Diagnostic Service Departments
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)
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)
EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
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)
EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
prEN ISO 18113-1:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
FprEN ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)
EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ISO 17511:2003

AENOR, In vitro diagnostic medical services

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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
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 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
UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
UNE-EN 61010-2-101:2004 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
UNE-EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
UNE-EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

RU-GOST R, In vitro diagnostic medical services

GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
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 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 EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R ISO 15194-2013 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
GOST R 55991.2-2014 In vitro diagnostics medical devices. Part 2. Automatic analyzer for immunoassays. Technical requirements for public procurement
GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement
GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST R 56894-2016 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
GOST R 55991.3-2014 In vitro diagnostics medical devices. Part 3. Automatic analyzers for biomolecular assays. Technical requirements for public procurement
GOST ISO 17511-2011 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
GOST R ISO 17511-2006 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
GOST IEC 61010-2-101-2013 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
GOST R 55991.5-2014 In vitro diagnostics medical devices. Part 5. Automatic analyzers for blood gas, metabolite and acid-base balance assessment. Technical requirements for public procurement
GOST ISO 18153-2011 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

GOSTR, In vitro diagnostic medical services

GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R 58437-2019 Examination of quality of medical diagnostic veterinary services. General requirements
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing
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 R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

Professional Standard - Medicine, In vitro diagnostic medical services

YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
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 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 0638-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

未注明发布机构, In vitro diagnostic medical services

DIN EN ISO 18113-4:2010 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 18113-3:2010 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 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
BS EN ISO 15193:2009(2016) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
BS EN ISO 15194:2009(2016) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

国家药监局, In vitro diagnostic medical services

YY/T 0639-2019 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Danish Standards Foundation, In vitro diagnostic medical services

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 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 6717:2021 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood
DS/ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
DS/EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
DS/EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, In vitro diagnostic medical services

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 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures
GB/T 29791.1-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment

Professional Standard - Goods and Materials, In vitro diagnostic medical services

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

国家发展和改革委员会, In vitro diagnostic medical services

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

CEN - European Committee for Standardization, In vitro diagnostic medical services

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/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
EN 12287:1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials
EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms@ definitions and general requirements
EN 12286:1998 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures (Incorporates Amendment A1: 2000)

Lithuanian Standards Office , In vitro diagnostic medical services

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 12322-2000 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
LST EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
LST EN 61326-2-6-2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2005)
LST EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020)
LST EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

Group Standards of the People's Republic of China, In vitro diagnostic medical services

T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）

Shanxi Provincial Standard of the People's Republic of China, In vitro diagnostic medical services

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

AT-ON, In vitro diagnostic medical services

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)
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 18113-1:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
OENORM EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

ZA-SANS, In vitro diagnostic medical services

SANS 1409:2008 Outlet sockets and probes for medical (gas and vacuum) services used in hospitals
SANS 1409:2004 Outlet sockets and probes for medical (gas and vacuum) services used in hospitals

IX-EU/EC, In vitro diagnostic medical services

98/79/EC-1998 Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
MEDDEV 2.14/4-2012 GUIDELINES RELATING TO THE APPLICATION OF: Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices
MEDDEV 2.14/3-2007 GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
98/79/EC CORR-1998 CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
MO95-1995 PROGRAMMING MANDATE TO CEN/CENELEC RELATING TO IN VITRO DIAGNOSTIC MEDICAL DEVICES

CH-SNV, In vitro diagnostic medical services

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)
SN EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

Indonesia Standards, In vitro diagnostic medical services

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

IT-UNI, In vitro diagnostic medical services

UNI ISO 21151:2021 In vitro diagnostic medical devices -- Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
UNI ISO 21474-1:2021 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation
UNI EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

European Committee for Electrotechnical Standardization（CENELEC）, In vitro diagnostic medical services

EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022/prAB Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 Particular requirements for in vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

国家市场监督管理总局、中国国家标准化管理委员会, In vitro diagnostic medical services

GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation

Japanese Industrial Standards Committee (JISC), In vitro diagnostic medical services

JIS C 61326-2-6:2023 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment
JIS C 1010-2-101:2013 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
JIS C 1010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
JIS C 1806-2-6:2012 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment
JIS C 61326-2-6:2019 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment

PL-PKN, In vitro diagnostic medical services

PN-EN ISO 17511-2021-09 E In vitro diagnostic medical devices -- Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2021)
PN-EN IEC 61326-2-6-2021-11 E Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020)

International Electrotechnical Commission (IEC), In vitro diagnostic medical services

IEC 61326-2-6:2020 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2018 RLV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2020 RLV Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

EU/EC - European Union/Commission Legislative Documents, In vitro diagnostic medical services

COM(2012) 541 FINAL-2012 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (2012/0267 (COD); Text with EEA relevance; SWD(2012) 273; SWD(2012) 274)