ZH
RU
ES

Global In Vitro Diagnostics

Global In Vitro Diagnostics, Total:499 items.

In the international standard classification, Global In Vitro Diagnostics involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Medical equipment, Hospital equipment, Company organization and management, Road vehicle systems, Diagnostic, maintenance and test equipment, Veterinary medicine, Vocabularies, Microbiology, Farming and forestry, Packaging and distribution of goods in general, Textile fibres, Products of the textile industry, Packaging materials and accessories, Quality, Applications of information technology, Air quality, Lamps and related equipment, Electrical and electronic testing, Construction materials.


AT-ON, Global In Vitro Diagnostics

  • 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), Global In Vitro Diagnostics

  • 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
  • BS ISO 27145-6:2015 Road vehicles. Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements. External test equipment
  • BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
  • 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 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated genomic DNA
  • 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
  • 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 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 EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • 22/30430514 DC BS ISO 27145-6. Road vehicles. Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements. Part 6. External test equipment
  • 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 EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
  • PD CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated DNA
  • BS PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
  • PD CEN/TS 17390-1:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA
  • 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 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
  • PD CEN/TS 17742:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
  • BS EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
  • BS ISO 15031-7:2013 Road vehicles. Communication between vehicle and external equipment for emissions-related diagnostics. Data link security
  • 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
  • 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
  • PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated cellular RNA
  • PD CEN/TS 17390-3:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining
  • 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 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
  • BS EN ISO 4307:2021 Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
  • 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 60601-2-41:2000 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
  • BS ISO 27145-2:2012 Road vehicles. Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements. Common data dictionary
  • BS EN ISO 16256:2012 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

Korean Agency for Technology and Standards (KATS), Global In Vitro Diagnostics

  • 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 R ISO 27145-6:2021 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 6: External test equipment
  • 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 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
  • KS R ISO 27145-3:2019 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 3: Common message dictionary
  • KS R ISO 27145-2:2019 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 2: Common data dictionary
  • KS P ISO TS 17822-1:2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi
  • KS P 0107-2017 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ─ general requirements, terms and definitions
  • KS C IEC 60601-2-41:2011 Medical electrical equipment-Part 2-41:Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

KR-KS, Global In Vitro Diagnostics

  • 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 R ISO 27145-6-2021 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 6: External test equipment
  • KS P ISO 20186-1-2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
  • KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
  • 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
  • KS R ISO 27145-3-2019 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 3: Common message dictionary
  • KS R ISO 27145-2-2019 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics(WWH-OBD) communication requirements —Part 2: Common data dictionary
  • KS P ISO TS 17822-1-2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi

International Organization for Standardization (ISO), Global In Vitro Diagnostics

  • 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 27145-6:2015 Road vehicles - Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements - Part 6: External test equipment
  • ISO 27145-6 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements — Part 6: External test equipment
  • ISO 27145-6:2023 Road vehicles — Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements — Part 6: External test equipment
  • ISO 20186-1:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
  • ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
  • ISO 20186-2:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
  • 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/IEEE 11073-10408:2010 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
  • 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 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 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
  • ISO 16256:2012 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
  • ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • ISO/IEEE 11073-10415:2010 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale

German Institute for Standardization, Global In Vitro Diagnostics

  • 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 18113-5:2013-01 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 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 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 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 20186-1:2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
  • DIN EN ISO 20186-2:2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019); German version EN ISO 20186-2:2019
  • 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 CEN/TS 17742:2022-07 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma; German version CEN/TS 17742:2022
  • 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 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
  • 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 20186-2:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
  • DIN CEN/TS 17390-1:2020-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA; German version CEN/TS 17390-1:2020
  • DIN CEN/TS 17390-2:2020-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA; German version CEN/TS 17390-2:2020
  • 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 20184-3:2021-11 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 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 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 ISO 20186-3:2020-04 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019); German version EN ISO 20186-3:2019
  • 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
  • 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

ES-UNE, Global In Vitro Diagnostics

  • 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-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 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 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
  • UNE-EN ISO 20186-2:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
  • UNE-CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (Endorsed by Asociación Española de Normalización in May of 2022.)
  • UNE-EN ISO 4307:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
  • 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
  • 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)
  • UNE-EN ISO 20186-3:2020 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
  • 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

Association Francaise de Normalisation, Global In Vitro Diagnostics

  • 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 C74-390:1985 Electromedical equipment. Diagnostic equipment from biopotentials other than cardiographic (ecg). Requirements for safety and operation for such equipment.
  • 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 S92-075-1*NF EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
  • XP S92-075-1*XP CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
  • NF EN ISO 20186-1:2019 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 1 : ARN cellulaire extrait
  • NF S92-075-2*NF EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2 : isolated genomic DNA
  • XP S92-075-2*XP CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2 : isolated genomic DNA
  • NF S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
  • NF EN ISO 20186-2:2019 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 2 : ADN génomique extrait
  • 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 12322:1999 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 ISO 4307:2021 Analyse de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour la salive - ADN humain extrait
  • NF EN 12322/A1:2002 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
  • NF S92-082*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 S92-075-3*NF EN ISO 20186-3:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3 : isolated circulating cell free DNA from plasma
  • NF EN ISO 20186-3:2019 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 3 : ADN libre circulant extrait du plasma
  • 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 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
  • 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 S97-518-10415*NF EN ISO 11073-10415:2011 Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.
  • NF S92-026*NF EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

国家药品监督管理局, Global In Vitro Diagnostics

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

BE-NBN, Global In Vitro Diagnostics

  • 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

European Committee for Standardization (CEN), Global In Vitro Diagnostics

  • 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
  • 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
  • EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • 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
  • FprCEN/TS 17742-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • prEN ISO 18703 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • 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
  • PD CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
  • PD CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
  • prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests
  • CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
  • 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
  • CEN/TS 17390-1:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
  • 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, Global In Vitro Diagnostics

  • 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/EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • DS/ISO 23118:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

AENOR, Global In Vitro Diagnostics

  • 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
  • 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

Professional Standard - Hygiene , Global In Vitro Diagnostics

  • WS/T 252-2005 Labeling of In Vitro Diagnosis Products
  • 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, Global In Vitro Diagnostics

RU-GOST R, Global In Vitro Diagnostics

  • 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 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 56894-2016 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices
  • GOST R ISO 15197-2015 In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
  • 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 ISO 16256-2015 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
  • GOST R ISO 20184-2-2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Part 2. Isolated proteins

Professional Standard - Medicine, Global In Vitro Diagnostics

  • 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 0648-2008 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment

Professional Standard - Agriculture, Global In Vitro Diagnostics

  • 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)
  • 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)
  • 139药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnostic anti-A anti-B blood typing reagent (monoclonal antibody)
  • 140药典 三部-2010 Chapter Ⅳ In vitro diagnostic anti-A and anti-B blood typing reagents (human serum)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Global In Vitro Diagnostics

  • 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
  • GB/T 19634-2005 In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing
  • GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
  • 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, Global In Vitro Diagnostics

  • 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, Global In Vitro Diagnostics

  • 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/CIET 250-2023 Fully cut off (micro warehouse) exterior wall structure and integrated fire protection and insulation system

GOSTR, Global In Vitro Diagnostics

  • 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

未注明发布机构, Global In Vitro Diagnostics

  • 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 18113-1:2010 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 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
  • BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
  • 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 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, Global In Vitro Diagnostics

  • 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
  • EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
  • EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
  • 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
  • EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins

Lithuanian Standards Office , Global In Vitro Diagnostics

  • 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

Professional Standard - Goods and Materials, Global In Vitro Diagnostics

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

国家发展和改革委员会, Global In Vitro Diagnostics

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

Jiangsu Provincial Standard of the People's Republic of China, Global In Vitro Diagnostics

  • DB32/T 4000-2021 Bovine tuberculosis diagnostic technology (γ-interferon in vitro ELISA method)

中华人民共和国国家卫生和计划生育委员会, Global In Vitro Diagnostics

  • WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline

US-CFR-file, Global In Vitro Diagnostics

  • 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, Global In Vitro Diagnostics

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

CH-SNV, Global In Vitro Diagnostics

  • 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, Global In Vitro Diagnostics

  • 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, Global In Vitro Diagnostics

  • 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
  • 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

Japanese Industrial Standards Committee (JISC), Global In Vitro Diagnostics

  • 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

国家市场监督管理总局、中国国家标准化管理委员会, Global In Vitro Diagnostics

  • 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, Global In Vitro Diagnostics

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

IT-UNI, Global In Vitro Diagnostics

  • UNI CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
  • UNI CEN/TS 17390-1-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
  • UNI CEN/TS 17390-2-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
  • UNI EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA
  • UNI EN ISO 23118:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

European Committee for Electrotechnical Standardization（CENELEC）, Global In Vitro Diagnostics

  • 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
  • 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

Indonesia Standards, Global In Vitro Diagnostics

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

Taiwan Provincial Standard of the People's Republic of China, Global In Vitro Diagnostics

  • CNS 15035-2006 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Canadian Standards Association (CSA), Global In Vitro Diagnostics

  • 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

International Electrotechnical Commission (IEC), Global In Vitro Diagnostics

  • 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 60601-2-41:2000 Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostic

  In vitro diagnostic reagents, poc in vitro diagnostics, In vitro diagnostic equipment, chemical in vitro diagnostics, In vitro diagnostic equipment, In vitro diagnostic business, In Vitro Diagnostic Biology, in vitro diagnostic technology, In Vitro Diagnostic Criteria, In vitro diagnostic project, clinical in vitro diagnostics, ivd in vitro diagnostics, IVD Network, pathological diagnosis in vitro diagnosis, in vitro diagnostic pcr, Pathological diagnosis and in vitro diagnosis, Global In Vitro Diagnostics, Global OBD, global diagnostics, Global Diagnostic System.

 



Copyright ©2007-2023 ANTPEDIA, All Rights Reserved