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Database: 365,228(8 Aug 2026)

pathological diagnosis in vitro diagnosis

pathological diagnosis in vitro diagnosis, Total:200 items.

The international standard classification for "pathological diagnosis in vitro diagnosis" includes: Medical Sciences and health care facilities in general , Veterinary medicine , Animal husbandry and breeding , Occupational safety. Industrial hygiene , Laboratory medicine .

The Chinese standard classification for "pathological diagnosis in vitro diagnosis" includes: , Diagnostic standard for public nuisance diseases , Sanitation in general , Diagnostic standard for occupational diseases , Animal quarantine, veterinary and epidemic prevention , Medical laboratory equipment , Beekeeping, silkworm keeping , Health quarantine .


Professional Standard - Hygiene

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

National Health Commission of the People's Republic of China

  • GBZ 104-2002 Diagnostic criteria for acute radiation sickness from external exposure
  • GBZ 56-2002 Diagnostic Criteria of Byssinosis
  • WS 588-2018 Diagnosis for hand, foot and mouth disease
  • GBZ 105-2002 Diagnostic criteria for chronic radiation sickness from external exposure
  • GBZ 25-2002 Pathologic Diagnostic Criteria of Pneumoconioses

Professional Standard - Agriculture

  • NY/T 553-2002 Diagnostic techniques for avian mycoplasmosis (mycoplasma gallisepticum)
  • 181药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • NY/T 573-2002 Diagnostic techniques for toxoplasmosis
  • 135药典 三部-2010 Each monograph catalog Ⅳ in vitro diagnostic human immunodeficiency virus antibody diagnostic kit (enzyme-linked immunoassay)
  • NY/T 562-2015 Diagnostic techniques for animal chlamydiosis
  • 161药典 三部-2015 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • NY/T 1469-2007 Diagnostic techniques of Nipah virus disease
  • 180药典 三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • NY/T 1953-2025 Pig Paroxysmal Nocturnal Hemoglobinuria Diagnosis Technology
  • NY/T 539-2017 Diagnostic techniques for paratuberculosis
  • 133药典 三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
  • 159药典 三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
  • NY/SY 182-2000 Chlamydiosis diagnosis technical regulations
  • NY/T 562-2002 Diagnostic techniques for animal chlamydiosis
  • 163药典 三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
  • 178药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
  • 179药典 三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • NY/SY 175-2000 Diagnosis technical rules for chicken mycoplasma disease
  • 160药典 三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
  • NY/T 4137-2022 Diagnostic techruques for porcine parvovirus infection
  • NY/T 549-2025 Akabane disease diagnostic technology
  • NY/T 4647-2025 Boundary disease diagnosis technology
  • 134药典 三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis C virus antibody diagnostic kit (enzyme-linked immunoassay)

Professional Standard - Aquaculture

  • SC/T 7241-2020 Code of diagnosis for abalone pustule disease
  • SC/T 7207.2-2007 Diagnostic Protocols for Marteiliosis of Oyster-Part 2:Histopathological Method
  • SC/T 7204.2-2007 Diagnostic Protocols for Taura Syndrome of Penaeid Shrimp - Part 2: Histopathological Method
  • SC/T 7206.2-2007 Diagnostic Protocols for Haplosporidiosis of Oyster - Part 2: Histopathological Method
  • SC/T 7202.3-2007 Diagnostic Protocols for Penaeus monodon-Type Baculovirus(MBV) of Penaeid Shrimp - Part 3: Histopathology Method
  • SC/T 7208.2-2007 Diagnostic Protocols for Perkinsosis of Shellfish-Part 2:Histopathological Method
  • SC/T 7203.2-2007 Diagnostic Protocols for Hepatopancreatic Parvovirus Disease of Penaeid Shrimp - Part 2: Histopathological Method
  • SC/T 7237-2020 Code of diagnosis for infection with Decapod iridescent virus 1
  • SC/T 7247-2025 Diagnostic Methods for Wheel Bug Disease
  • SC/T 7209.2-2007 Diagnostic Protocols for Mikrocytosis of Oyster-Part 2:Histopathological Method
  • SC/T 7205.2-2007 Diagnostic Protocols for Bonamiosis of Oyster-Part 2:Histopathological Method

Professional Standard - Medicine

  • YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

Group Standards of the People's Republic of China

Occupational Health Standard of the People's Republic of China

Jiangsu Provincial Standard of the People's Republic of China

  • DB32/T 4000-2021 Diagnostic technique for Bovine Tuberculosis by interferon-gamma ELISA assay

Professional Standard - Commodity Inspection

Beijing Provincial Standard of the People's Republic of China

Shanxi Provincial Standard of the People's Republic of China

Guangxi Provincial Standard of the People's Republic of China

Liaoning Provincial Standard of the People's Republic of China

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 23640-2019(2024) In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
  • KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 23640-2024 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • 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

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Ente Nazionale Italiano di Unificazione

  • UNI EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • UNI EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • UNI EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • UNI EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
  • UNI EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • UNI EN 592:1996 In vitro diagnostic systems. Requirements for user manual for in vitro diagnostic instruments for home use.
  • UNI EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use.
  • UNI EN ISO 18113-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self- testing
  • UNI EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • UNI EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • UNI EN 591:1996 In vitro diagnostic systems. Requirements for user manuals for vitro diagnostic instruments for professional use.
  • UNI EN ISO 18113-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self- testing
  • UNI EN 376:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for self-testing.

Standards Norway

  • NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
  • NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
  • NS-EN 592:1994 In vitro diagnostic systems — Requirements for user manual for in vitro diagnostic instruments for home use
  • NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • NS-EN 591:1994 In vitro diagnostic systems — Requirements for user manuals for in vitro diagnostic instruments for professional use
  • NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Austrian Standards

  • ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use
  • ONORM EN 376-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing

Bureau of Indian Standards

  • IS/ISO 23640-2011 In Vitro Diagnostic Medical Devices —— Evaluation of Stability of in vitro Diagnostic Reagents

British Standards Institution (BSI)

  • 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 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
  • 09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing 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

Association Francaise de Normalisation

  • NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
  • 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 S92-016:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIRMENTS FOR USER MANUELS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 591).
  • 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 S92-010:1992 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).

International Organization for Standardization (ISO)

  • ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

German Institute for Standardization

  • 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 ISO 23640:2012-03 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • DIN EN ISO 23640:2013-09 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • DIN EN ISO 23640 E:2013-04 Draft Document - 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 23640 E:2013 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
  • DIN 58943 Bb.1:2003 Medical microbiology - Diagnosis of tuberculosis - Guidance for the specialized use of methods of detection

Danish Standards Foundation

  • DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • DS/EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
  • DS/EN 376:1993 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
  • DS/EN 592:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or home use
  • DS/EN 591:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or professional use

Belgian Standards Institute

  • NBN EN 591-1995 In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
  • NBN EN 592-1995 In vitro diagnostic systems - Requirements for user manual for in vitro diagnostic instruments for home 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)

  • EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
  • EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • 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)

Swedish Institute for Standards

  • SS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

US Federal Contractor Registration (USFCR)

Gosstandart of Russia

  • GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology