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pathological diagnosis in vitro diagnosis

pathological diagnosis in vitro diagnosis, Total:494 items.

In the international standard classification, pathological diagnosis in vitro diagnosis involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Farming and forestry, Occupational safety. Industrial hygiene, Veterinary medicine, Dentistry, Medical equipment, Hospital equipment, Company organization and management, Biology. Botany. Zoology, Vocabularies, Microbiology, Fishing and fish breeding, Packaging and distribution of goods in general, Textile fibres, Products of the textile industry, Equipment for railway/cableway construction and maintenance, Packaging materials and accessories, Applications of information technology.

Professional Standard - Hygiene , pathological diagnosis in vitro diagnosis

WS/T 210-2001 Standard of pathologic diagnosis of Keshan disease
WS/T 252-2005 Labeling of In Vitro Diagnosis Products
WS 290-2008 Diagnostic criteria for leptospirosis
WS 176-1999 Diagnostic criteria and principles of management for radiation induced gonad diseases
WS 213-2001 Diagnostic criteria and principles of management of viral hepatitis C
WS 237-2003 Diagnostic criteria and principles of management of lymphogranuloma venereum
WS/T 8-1996 Diagnostic criteria and principles of management for food poisoning of enteropathogenic Eschrichia coli

AT-ON, pathological diagnosis in vitro diagnosis

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

British Standards Institution (BSI), pathological diagnosis in vitro diagnosis

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
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use
21/30416041 DC BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 4. In vitro diagnostic reagents for self-testing
21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional use
BS EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 15197:2013 In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
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 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
BS EN ISO 15197:2015 Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
BS EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
BS EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteins
BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
BS EN 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
BS PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
BS EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated genomic DNA
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

Korean Agency for Technology and Standards (KATS), pathological diagnosis in vitro diagnosis

KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P SIO 18113-2-2012 In vitro diagnostic medical devices--Information supplied by the manufacturer (labelling)--Part 2：In vitro diagnostic reagents for professional use
KS P ISO 18113-4-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
KS P ISO 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
KS P ISO 15197:2010 In vitro diagnostic test systems－Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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 19001:2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS P ISO 15197:2017 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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 0108-2017 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ─ Laboratory quality practice guide
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 0107-2017 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ─ general requirements, terms and definitions
KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
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

KR-KS, pathological diagnosis in vitro diagnosis

KS P ISO 23640-2019 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 19001-2017(2022) In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 15197-2017(2022) In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
KS P ISO 15197-2017 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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 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 ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

International Organization for Standardization (ISO), pathological diagnosis in vitro diagnosis

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 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 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 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
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

German Institute for Standardization, pathological diagnosis in vitro diagnosis

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 15197:2015-12 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 / Note: DIN EN ISO 15197 (2013-11) remains valid alongside this stand...
DIN EN ISO 18113-4:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
DIN EN 1659:1997-01 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions; German version EN 1659:1996
DIN EN ISO 18113-3:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
DIN EN ISO 18113-5:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011
DIN EN 13641:2002-08 Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts
DIN EN 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 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 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
DIN EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans; German version EN 14254:2004
DIN 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 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 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
DIN EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2013
DIN 6870-2:2012-11 Quality management system in medical radiology - Part 2: Radiological diagnosis and intervention / Note: Applies in conjunction with DIN 6870-100 (2012-11).
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 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

ES-UNE, pathological diagnosis in vitro diagnosis

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE-CEN ISO/TS 5798:2022 In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022) (Endorsed by Asociación Española de Normalizaci...
UNE-EN ISO 6717:2022 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
UNE-EN ISO 4307:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

Association Francaise de Normalisation, pathological diagnosis in vitro diagnosis

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 S92-026:2004 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 S92-026*NF EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF EN ISO 15197:2015 Systèmes d'essais de diagnostic in vitro - Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré
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 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 S92-041*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 S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
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 S92-012*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 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 S92-076*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 S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice

国家药品监督管理局, pathological diagnosis in vitro diagnosis

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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, pathological diagnosis in vitro diagnosis

GB 8783-1988 Pathologic diagnostic criteria of pneumoconiosis
GB/T 32945-2016 In Vitro Detection of Bovine Tuberculosis Diagnosis Interferon-γ Method
GB/T 28630.4-2012 Diagnostic protocols for white spot disease.Part 4：Histopathology method
GB 15975-1995 Diagnostic criteria and management of gonorrhea
GB 8280-2000 Diagnostic criteria and principles of management for acute radiation sickness from external exposure
GB 8281-2000 Diagnostic criteria and principles of management for chronic radiation sickness from external exposure
GB 17013-1997 Diagnostic criteria and principles of management for hydatid disease
GB 17014-1997 Diagnostic creteria and principles of management of rabies
GB 15973-1995 Diagnostic criteria and management of leprosy
GB 16376-1996 Diagnostic criteria and principles of management of byssinosis
GB 16388-1996 Diagnostic criteria and principles of management for subacute radiation sickness from external exposure
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB 4868-1996 Diagnostic criteria and principles of management of occupational beryllium disease
GB 3234-1982 Diagnostic criteria and principles of management of industrial fluorosis
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 15977-1995 Diagnostic criteria and principles of management of schistosomiasis
GB 8284-1987 Diagnostic criteria and principles of management for radiation sickness from internal exposure
GB 7798-1987 Diagnostic criteria and principles of management of occupational chromium induced nasal disease
GB 7808-1987 Diagnostic criteria and principles of management of occupational melanosis
GB 8782-1988 Diagnostic criteria and principles of management of occupational decompression sickness
GB 17010-1997 Diagnostic criteria and principles of managements for viral hepatitis A
GB 17011-1997 Diagnostic criteria and principles of management for viral hepatitis E
GB 8282-2000 Diagnostic criteria and principles of management for radiation skin diseases
GB 16381-1996 Diagnostic criteria and principles of management of occupational dental erosion
GB 17149.1-1997 Diagnostic criteria and principles of management of skin diseases induced by cosmetics--General guideline
GB 16379-1996 Diagnostic criteria and principles of management of occupational toxic hepatopathy
GB 16390-1996 Diagnostic criteria and principles of management for radiation thyroid diseases
GB 4869-1985 Diagnostic criteria and principles of management of occupational vibration disease
GB 7804-1987 Diagnostic criteria and principles of management of occupational dermatosis
GB 16389-1996 Diagnostic criteria and principles of management for external radiation bone injuries
GB/T 19634-2005 In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing

中华人民共和国国家卫生和计划生育委员会, pathological diagnosis in vitro diagnosis

GBZ 25-2002 Pathological diagnostic criteria for pneumoconiosis
WS/T 568-2017 Diagnosis of extraintestinal abscess in amoebiasis
GBZ 105-2002 Diagnostic criteria for chronic radiation sickness from external exposure
GBZ 104-2002 Diagnostic criteria for acute radiation sickness from external exposure
WS 195-2001 Diagnostic criteria and principles of mangement of legionnaires disease
GB 15999-1995 Diagnostic criteria and principles of management for viral hepatitis D
GBZ 105-2017 Diagnosis of chronic radiation sickness from occupational external exposure (replaces GBZ 105-2002)
WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
GB 6989-1986 Diagnosis criteria and treatment principles of chronic methylmercury poisoning caused by water pollution

BE-NBN, pathological diagnosis in vitro diagnosis

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), pathological diagnosis in vitro diagnosis

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 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 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)
EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
prEN ISO 18113-5:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
prEN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
FprEN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
EN ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
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 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests

Professional Standard - Agriculture, pathological diagnosis in vitro diagnosis

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)
NY/T 553-2002 Diagnostic techniques for avian mycoplasmosis （mycoplasma gallisepticum）
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)
NY/T 562-2015 Diagnostic techniques for animal chlamydiosis
NY/T 562-2002 Diagnostic techniques for animal chlamydiosis
NY/SY 182-2000 Chlamydiosis diagnosis technical regulations
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)
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)
NY/SY 175-2000 Diagnosis technical rules for chicken mycoplasma disease
163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
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)
WS/T 195-2001 Diagnostic criteria and treatment principles of Legionnaires' disease
137药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis 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)
NY/T 1953-2010 Diagnostic technique for Mycoplasma suis(Eperythrozoon suis)
164药典三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
NY/T 4302-2023 Standards for file management of animal disease diagnostic laboratory
121兽药产品说明书范本第三册-2013 Instructions for Diagnostic Products Fluorescent Antibody to CSFV
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
137兽药典三部-2015 Text table of contents Diagnostic products Fluorescent antibody to classical swine fever virus
120兽药产品说明书范本第三册-2013 Diagnostic Products Swine Fever Virus Enzyme Labeled Antibody Instructions
NY/T 1807-2009 Diagnoses criterion and control technique of Banana Fusarium Wilt
136兽药典三部-2015 Text table of contents diagnostic products classical swine fever virus enzyme-labeled antibody
118兽药产品说明书范本第三册-2013 Diagnostic Products Porcine Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit Instructions
119兽药产品说明书范本第三册-2013 Diagnostic Products Porcine Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit Instructions
135兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit
134兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit
105兽药产品说明书范本第三册-2013 Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit Instructions
106兽药产品说明书范本第三册-2013 Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit Instructions
121兽药典三部-2015 Text Contents Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit
122兽药典三部-2015 Text Contents Diagnostic Products Cattle and Sheep Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit
110兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Virus Asia Type 1 Antibody Liquid Phase Blocking ELISA Detection Kit
182药典三部-2020 Monograph IV In Vitro Diagnostic Kits for Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus Type 1 Nucleic Acid Detection
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)
116兽药产品说明书范本第三册-2013 Diagnostic product chlamydiosis complement fixation test antigen, positive serum and negative serum instructions
132兽药典三部-2015 Text Table of Contents Diagnostic Products Chlamydia Complement Fixation Test Antigen, Positive Serum and Negative Serum
109兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Virus Nonstructural Protein 3ABC ELISA Antibody Detection Kit

Professional Standard - Aquaculture, pathological diagnosis in vitro diagnosis

SC/T 7208.2-2007 Diagnostic Protocols for Perkinsosis of Shellnsh- Part 2: Histopathological Method
SC/T 7209.2-2007 Diagnostic Protocols for Mikrocytosis 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 7205.2-2007 Diagnostic Protocols for Bonamiosis of Oyster Part 2: Histopathological Method
SC/T 7206.2-2007 Diagnostic Protocols for Haplosporidiosis of Oyster-Part 2: Histopathological Method
SC/T 7207.2-2007 Diagnostic protocols for Marteiliosis of Oyster-Part 2: Histopathological Method
SC/T 7203.2-2007 Diagnostic Protocols for Hepatopancreatic Parvovirus Disease of Penaeid Shrimp Part 2: Histopathological Method
SC/T 7204.2-2007 Diagnostic Protocols for Taura Syndrome of Penaeid Shrimp-Part 2: Histopathological Method

Danish Standards Foundation, pathological diagnosis in vitro diagnosis

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 ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
DS/EN 1659:1997 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
DS/EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/ISO 6717:2021 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood
DS/CEN/TS 17626:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for human specimen – Isolated microbiome DNA
DS/ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA

Occupational Health Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

GBZ(卫生) 25-2014 Pathological diagnosis criteria of pneumoconioses
GBZ 25-2014 Pathological diagnosis criteria of pneumoconioses
GBZ 99-2002 Diagnostic criteria for subacute radiation sickness from external exposure

AENOR, pathological diagnosis in vitro diagnosis

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 41805-3:2009 IN Building diagnosis. Part 3. Constructive and pathological studies
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 41805-5:2009 IN Building diagnosis - Part 5 - Pathological study of the structure of the building-Masonry units.
UNE 41805-12:2009 IN Building diagnosis - Part 12 - Pathological study of the building. Internal partitions and finishings
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE 41805-13:2010 IN Building diagnosis - Part 13 - Pathological study of the building - Facilities
UNE 41805-9:2009 IN Building diagnosis - Part 9 - Pathological study of the building - Roofings
UNE-EN 1659:1997 IN VITRO DIAGNOSTIC SYSTEMS. CULTURE MEDIA FOR MICROBIOLOGY. TERMS AND DEFINITIONS.
UNE 41805-8:2009 IN Building diagnosis - Part 8 - Pathological study of the structure of the building - Wood structures
UNE-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE 41805-10:2009 IN Building diagnosis - Part 10: Pathological study of the building - Nonstructural facades
UNE 41805-7:2009 IN Building diagnosis - Part 7 - Pathological study of the structure of the building -Metallic structures
UNE-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
UNE 41805-6:2009 IN Building diagnosis - Part 6 - Pathological study of the structure of the building - Concrete structures
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 41805-11:2009 IN Building diagnosis - Part 11: Pathological study of the building - Carpentry of windows and locks
UNE 41805-4:2009 IN Building diagnosis. Part 4 - Pathological study of the structure of the building. Land and laying of foundations

US-FCR, pathological diagnosis in vitro diagnosis

FCR 21 CFR PART 809-2015 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
FCR 21 CFR PART 809-2013 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

Jiangsu Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

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

Beijing Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

DB11/T 1805-2020 Laboratory Animal Pathological Diagnosis Specification
DB11/T 1053.4-2013 Experimental Fish Part 4: Specifications for Pathological Diagnosis
DB11/T 828.4-2011 Miniature pigs for laboratory use Part 4: Specifications for pathological diagnosis
DB11/T 1462.1-2017 Laboratory Animal Pathological Diagnosis Specifications Part 1: Experimental Pigs
DB11/T 1462.2-2017 Laboratory Animal Pathological Diagnostic Specifications Part 2: Experimental Cattle
DB11/T 1462.3-2017 Laboratory animal pathological diagnosis specification part 3: sheep used in experiments
DB11/T 1462.4-2018 Laboratory animal pathological diagnosis specification part 4: experimental marmosets
DB11/T 1462.5-2018 Laboratory Animal Pathological Diagnostic Specifications Part 5: Experimental Gerbils

Shanxi Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

DB14/T 2664-2023 Pathological Diagnosis of Experimental Miniature Pigs
DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

Group Standards of the People's Republic of China, pathological diagnosis in vitro diagnosis

T/CHSA 004-2020 Guidelines for pathological diagnosis of salivary gland tumors
T/CALAS 13-2017 Laboratory animal - Specifi cation of pathological diagnosis for tree shrew
T/CHSA 003-2020 Oral cancer and oropharyngeal cancer pathological diagnosis standard
T/NAHIEM 36-2021 In-vitro diagnostic management (distribution) enterprise group standards
T/CNMIA 0032-2021 Competence Evaluation Criteria for Independent Pathological Diagnosis Center/Pathology Laboratory
T/ZMDS 40001-2021 Guidelines for values assignment of calibrator of IVD
T/CALAS 60-2018 Laboratory animals - Giudeline to pathological diagnosis of mongolian gerbil
T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
T/CSBME 051-2022 Requirements of pathological datasets for assisted diagnosis of chronic myelogenous leukemia (CML)
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/NAASS 056-2023 Technical regulations for diagnosis, prevention and treatment of Mycoplasmosis bovis in large-scale beef cattle farms
T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）
T/CI 048-2023 Intelligent fault diagnosis and operation maintenance management technology and application guide for Subway train appearance
T/CESA 1149-2021 Application of artificial intelligence chip - Technical requirements to the auxiliary diagnostic system of pathological image analysis

RU-GOST R, pathological diagnosis in vitro diagnosis

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 25386-1991 Agricultural animals. Methods of laboratory diagnostics of leptospirosis
GOST R 59551-2021 Seed potatoes. Sampling and methods of diagnostics of phytopathogens
GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R ISO 15197-2015 In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
GOST EN 14136-2016 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R ISO 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

Professional Standard - Medicine, pathological diagnosis in vitro diagnosis

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

Jilin Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

DB22/T 3473-2023 Etiological diagnosis technology of bovine respiratory syncytial disease
DB22/T 1924-2013 Jilin Province Occupational Disease Diagnosis and Appraisal Management Standards

国家药监局, pathological diagnosis in vitro diagnosis

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 1789.6-2023 In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 1709-2020 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic 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 1728-2021 Reference method for in vitro activity testing of yeast-like fungal antimicrobials related to systemic infectious diseases for clinical laboratory testing and in vitro diagnostics

GOSTR, pathological diagnosis in vitro diagnosis

GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST ISO 15197-2011 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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

未注明发布机构, pathological diagnosis in vitro diagnosis

DIN EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
DIN EN ISO 15197:2004 Test systems for in vitro diagnostics – requirements for blood glucose measuring systems for self-use in diabetes mellitus
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
BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
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 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

农业农村部, pathological diagnosis in vitro diagnosis

NY/T 3191-2018 Dairy cow ketosis diagnosis and group risk monitoring technology

Indonesia Standards, pathological diagnosis in vitro diagnosis

SNI ISO 15197:2009 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
SNI 7304-2009

CEN - European Committee for Standardization, pathological diagnosis in vitro diagnosis

EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
PD CEN/TS 17305:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA

Lithuanian Standards Office , pathological diagnosis in vitro diagnosis

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 ISO 15197:2004 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
LST EN ISO 15197:2004/AC:2005 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
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

Yunnan Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

DB53/T 1167.3-2023 Medical donor pigs for xenotransplantation Part 3: Pathological diagnostic specifications
DB53/T 802.4-2016 Experimental Miniature Pig Part 4: Specifications for Pathological Diagnosis

Professional Standard - Goods and Materials, pathological diagnosis in vitro diagnosis

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

国家发展和改革委员会, pathological diagnosis in vitro diagnosis

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

Taiwan Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

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

国家技术监督局、中华人民共和国卫生部, pathological diagnosis in vitro diagnosis

GB/T 17149.1-1997 Diagnostic criteria and principles of management of skin diseases induced by cosmetics--General guideline

Hunan Provincial Standard of the People's Republic of China, pathological diagnosis in vitro diagnosis

DB43/T 958.4-2014 Miniature pigs for laboratory use Part 4: Specifications for pathological diagnosis
DB43/T 959.4-2014 Designated Pathogen Free (DPF) Medical Donor Pigs for Xenotransplantation Part 4: Specifications for Pathological Diagnosis

Standard Association of Australia （SAA）, pathological diagnosis in vitro diagnosis

石家庄市市场监督管理局, pathological diagnosis in vitro diagnosis

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

Canadian Standards Association (CSA), pathological diagnosis in vitro diagnosis

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
CAN/CSA-ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (Second Edition)

IX-EU/EC, pathological diagnosis in vitro diagnosis

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
98/79/EC CORR-1998 CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices

US-CFR-file, pathological diagnosis in vitro diagnosis

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

中华人民共和国卫生部, pathological diagnosis in vitro diagnosis

GB/T 6989-1986 Diagnostic criteria and principle of treatment for chronic methyl-mercury poisoning caused by water pollution

IN-BIS, pathological diagnosis in vitro diagnosis

IS 4015 Pt.2-1967

PT-IPQ, pathological diagnosis in vitro diagnosis

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

Japanese Industrial Standards Committee (JISC), pathological diagnosis in vitro diagnosis

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, pathological diagnosis in vitro diagnosis

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

IT-UNI, pathological diagnosis in vitro diagnosis

UNI CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA