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Production of in vitro diagnostic reagents

Production of in vitro diagnostic reagents, Total:186 items.

In the international standard classification, Production of in vitro diagnostic reagents involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Medical equipment, Company organization and management, Packaging and distribution of goods in general, Packaging materials and accessories, Vocabularies, Microbiology.

Korean Agency for Technology and Standards (KATS), Production 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
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 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 19001:2010 In virto diagnostic medical devices－Information supplied by the manufacturer with in vitro gnostic reagents for staining in biology
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 17511:2010 In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values assigned to calibrators and control materials
KS P ISO 17822:2021 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
KS P ISO 20776-2:2020 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Eval

KR-KS, Production 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 19001-2017(2022) In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 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 16256-2022 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 infec
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 17822-2021 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
KS P ISO 20776-2-2020 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Eval

German Institute for Standardization, Production of in vitro diagnostic reagents

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 19001:2013-07 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this stan...
DIN EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013
DIN EN 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 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 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 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/DIS 16256:2021); German and English
DIN EN 13641:2002 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 16256:2022-02 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 16256:2021); German version EN I...
DIN EN 18000-1:2023-10 Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control; German and English version prEN 18000-1:2023 / Note: Date of issue 2023-09-01
DIN 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 (ISO 16256:2012); German version EN ISO 16256:2012

ES-UNE, Production of in vitro diagnostic reagents

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 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 16256:2021) (Endorsed by Asociac...

Association Francaise de Normalisation, Production of in vitro diagnostic reagents

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 S92-040*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 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 S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF S92-010-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.
NF S92-010-4*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 S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
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 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
NF S92-041*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 S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
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 EN ISO 18153:2004 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Traçabilité métrologique des valeurs de concentration catalytique des enzymes attribuées aux agents d'étalonnage et aux matériau...
NF EN ISO 16256:2021 Laboratoires d'analyses de biologie médicale et systèmes de diagnostic in vitro - Méthode de référence de microdilution en milieu liquide pour soumettre à essai l'activité in vitro des agents antimicrobiens par rapport aux levures impliquées ...
NF S92-021*NF EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
NF S92-012*NF EN 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
NF S92-053-1*NF EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1 : reference method for testing the in vitro activity of anti

国家药品监督管理局, Production of in vitro diagnostic reagents

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

European Committee for Standardization (CEN), Production of in vitro diagnostic reagents

EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
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 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
EN 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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 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 ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
EN 376:2002 Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing
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)
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)
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)
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests
EN ISO 20776-1:2020 Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi
EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO 18153:2003

RU-GOST R, Production of in vitro diagnostic reagents

GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
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 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
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 15194-2013 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation

British Standards Institution (BSI), Production of in vitro diagnostic reagents

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 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
BS EN 13640:2002 Stability testing 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 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents 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
BS EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
BS EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
BS EN 12286:1999(2001) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS EN 12286:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
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 ISO/TS 17822-1:2014 $iI$in $iv$ii$it$ir$io diagnostic test systems. Qualitative nucleic acid-based $ii$in $iv$ii$it$ir$io examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions
BS EN ISO 16256:2021 Tracked Changes. 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

Danish Standards Foundation, Production of in vitro diagnostic reagents

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

Professional Standard - Medicine, Production of in vitro diagnostic reagents

YY/T 1244-2014 Purified water for in vitro diagnostic reagents
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 0688.1-2008 Clinical laboratory testing and in vitro diagnostic test systems -Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices -Part 1: Reference method for testing the in vitro activity of antimicrobia

AENOR, Production of in vitro diagnostic reagents

UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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 18113-2:2012 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 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
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 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 (ISO 16256:2012)
UNE-EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim

国家药监局, Production of in vitro diagnostic reagents

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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Production of in vitro diagnostic reagents

GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
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 29791.2-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use

Professional Standard - Agriculture, Production of in vitro diagnostic reagents

163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
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)
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum 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
164药典三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
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)
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test 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)
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)
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)
1342药典化学药和生物制品卷-2010 Chapter 18 Biological Products 8. In Vivo Diagnostic Reagent Sik Test Toxin
139药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic anti-A anti-B blood typing reagent (monoclonal antibody)
1341药典化学药和生物制品卷-2010 Chapter 18 Biological Products 8. In Vivo Diagnostic Reagent Brucella Pure Protein Derivatives
1340药典化学药和生物制品卷-2010 Chapter 18 Biological Products 8. In Vivo Diagnostic Reagent BCG Pure Protein Derivatives
140药典三部-2010 Chapter Ⅳ In vitro diagnostic anti-A and anti-B blood typing reagents (human serum)
1339药典化学药和生物制品卷-2010 Chapter 18 Biological Products 8. In Vivo Diagnostic Reagent Tuberculin Pure Protein Derivatives
821兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Foot-and-Mouth Disease Virus Nonstructural Protein Antibody Monoclonal Antibody Blocking ELISA Diagnostic 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
1050兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Foot-and-Mouth Disease Virus Nonstructural Protein Antibody Monoclonal Antibody Blocking ELISA Diagnostic Kit Instructions

Professional Standard - Goods and Materials, Production of in vitro diagnostic reagents

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

Group Standards of the People's Republic of China, Production of in vitro diagnostic reagents

T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents

国家发展和改革委员会, Production of in vitro diagnostic reagents

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

International Organization for Standardization (ISO), Production of in vitro diagnostic reagents

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 18113-2:2022 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 19001:2002 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 20776-1:2019 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Refe
ISO/TS 17822-1:2014 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 definitions

Lithuanian Standards Office , Production of in vitro diagnostic reagents

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)

CEN - European Committee for Standardization, Production of in vitro diagnostic reagents

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 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 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim

中华人民共和国国家卫生和计划生育委员会, Production of in vitro diagnostic reagents

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

未注明发布机构, Production of in vitro diagnostic reagents

BS EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
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 ISO 16256:2022 Laboratory medical examinations and in vitro diagnostic systems – Broth microdilution reference method for testing the in vitro activity of antimicrobial substances against budding fungi that cause infectious diseases
BS ISO 17822:2020(2021) In vitro diagnostic test systems — Nucleic acid amplification - based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide

Indonesia Standards, Production of in vitro diagnostic reagents

SNI ISO 19001:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

AT-ON, Production of in vitro diagnostic reagents

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 18113-4:2021 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
OENORM EN 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/DIS 16256:2021)

GOSTR, Production of in vitro diagnostic reagents

GOST R EN 13641-2010 Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Shanxi Provincial Standard of the People's Republic of China, Production of in vitro diagnostic reagents

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