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Diagnostic reagents, UV

Diagnostic reagents, UV, Total:259 items.

In the international standard classification, Diagnostic reagents, UV involves: Medical sciences and health care facilities in general, Laboratory medicine, Analytical chemistry, Power transmission and distribution networks, Medical equipment, Company organization and management, Occupational safety. Industrial hygiene, Products of the textile industry, Packaging and distribution of goods in general, Packaging materials and accessories, Air quality, Diagnostic, maintenance and test equipment, Products of the chemical industry, Road vehicle systems.

Korean Agency for Technology and Standards (KATS), Diagnostic reagents, UV

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 19001:2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacture
KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS K 0850-2019 Test method for ultraviolet protection rate and ultraviolet protection factor of textiles
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 1012-2010 Standard materials for the quality control of genetic diagnostic tests of Plasmodium falciparum malaria
KS P 1013-2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium falciparum malaria
KS P 1014-2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium vivax malaria
KS P ISO 15197:2017 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
KS R ISO 15031-4-2016(2021) Road vehicles－Communication between vehicle and external equipment for emissions－related diagnostics－Part 4：External test equipment
KS R ISO 15031-4:2016 Road vehicles－Communication between vehicle and external equipment for emissions－related diagnostics－Part 4：External test equipment
KS P ISO 15197:2010 In vitro diagnostic test systems－Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

KR-KS, Diagnostic reagents, UV

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P 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 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 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 R ISO 15031-4-2016 Road vehicles－Communication between vehicle and external equipment for emissions－related diagnostics－Part 4：External test equipment
KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance

German Institute for Standardization, Diagnostic reagents, UV

DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN ISO 23640:2012 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 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 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 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 18113-2:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
DIN EN ISO 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 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 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 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans; German version EN 14254:2004
DIN EN 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 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 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 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, Diagnostic reagents, UV

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...
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)

Association Francaise de Normalisation, Diagnostic reagents, UV

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 S92-032:2002 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 S92-040*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 S92-010:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 375).
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 S92-010-4*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 S92-012*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 S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
NF S92-036:2004 In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans.
NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
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 S92-012*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 T75-613*NF EN ISO 24442:2012 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection.
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 EN ISO 20184-3:2021 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 3 : ADN extrait

国家药品监督管理局, Diagnostic reagents, UV

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

European Committee for Standardization (CEN), Diagnostic reagents, UV

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 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
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 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
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 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
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 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 591-1991 In-vitro diagnostic systems; requirements for user manual of in-vitro diagnostic instruments for professional use
EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
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 ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 13641:2002 Elimination or reduction of risk of infection related to 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 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003
EN ISO 24442:2022 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2022)
EN ISO 24442:2011 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus

Professional Standard - Medicine, Diagnostic reagents, UV

YY/T 1244-2014 Purified water for in vitro diagnostic reagents
YY/T 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
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 1221-2013 Cardiac troponini I (cTnI ) diagnostic kit.(Colloid gold method)
YY/T 1220-2013 (Creatine kinase isoenzyme MB) (CK-MB) diagnostic kit.(Colloid gold method)

Danish Standards Foundation, Diagnostic reagents, UV

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
DS/EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

British Standards Institution (BSI), Diagnostic reagents, UV

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 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 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
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 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
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 376:2002 Information supplied by the manufacturer with 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 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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 EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
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
BS ISO 15031-4:2014 Road vehicles. Communication between vehicle and external equipment for emissions-related diagnostics. External test equipment
BS EN ISO 24442:2011 Cosmetics. Sun protection test methods. In vivo determination of sunscreen UVA protection
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 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 15197:2013 In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
BS ISO 27145-6:2015 Road vehicles. Implementation of World-Wide Harmonized On-Board Diagnostics (WWH-OBD) communication requirements. External test equipment
BS EN ISO 20776-2:2007 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test device

AENOR, Diagnostic reagents, UV

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 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Diagnostic reagents, UV

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
GB 7795-1987 Diagnostic criteria and principles of management of occupational acute electric ophthalmia(Kerato-conjunctivitis caused by ultraviolet rays)
GB/T 9721-1988 Chemical reagent--General rules for the molecular absorption spectrophotometry(ultraviolet and visible)
GB/T 9721-2006 chemical reagent General rules for the molecular absorption spectrophotometry (ultraviolet and visible)
GB 9721-1988 Molecular Absorption Spectrophotometry of Chemical Reagents General Rules (Ultraviolet and Visible Parts)
GB/T 42193.4-2022 Road vehicles—Communication between vehicle and external equipment for emissions-related diagnostics—Part 4: External test equipment

AT-ON, Diagnostic reagents, UV

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 18113-4:2021 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

International Organization for Standardization (ISO), Diagnostic reagents, UV

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability 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 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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 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 15031-4:2014 Road vehicles - Communication between vehicle and external equipment for emissions-related diagnostics - Part 4: External test equipment
ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO 24442:2011 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection
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

Professional Standard - Electricity, Diagnostic reagents, UV

DL/T 345-2010 Charged device technology application guidelines for UV diagnostics
DL/T 345-2019 Guidelines for the application of ultraviolet diagnostic technology for live equipment

Professional Standard - Agriculture, Diagnostic reagents, UV

163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic 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
137药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis rapid plasma reagin diagnostic reagents
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test 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)
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)
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum 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)
180药典三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
159药典三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
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)
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen 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)
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)
140药典三部-2010 Chapter Ⅳ In vitro diagnostic anti-A and anti-B blood typing reagents (human serum)
139药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic anti-A anti-B blood typing reagent (monoclonal 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
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
111兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Type O Antibody Liquid Phase Blocking ELISA Detection 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
896兽药质量标准2017年版 Volume I of Biological Products Quality Standards for Veterinary Drugs Immunohistochemical Diagnostic Reagents for Immunohistochemistry
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
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
95兽药产品说明书范本第三册-2013 Diagnostic products Mycoplasma gallisepticum crystal violet serum plate agglutination test antigen, positive serum and negative serum instructions
732兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Mad Cow Disease Immunohistochemical Diagnostic Reagents
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
108兽药典三部-2015 Text Contents Diagnostic Products Mycoplasma Gallisepticum Crystal Violet Serum Plate Agglutination Test Antigen, Positive Serum and Negative Serum

RU-GOST R, Diagnostic reagents, UV

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 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
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 EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R ISO 15197-2015 In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus

BE-NBN, Diagnostic reagents, UV

NBN-EN 376-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
NBN-EN 375-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for professional use

Professional Standard - Goods and Materials, Diagnostic reagents, UV

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

Group Standards of the People's Republic of China, Diagnostic reagents, UV

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, Diagnostic reagents, UV

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

国家药监局, Diagnostic reagents, UV

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

CEN - European Committee for Standardization, Diagnostic reagents, UV

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

中华人民共和国国家卫生和计划生育委员会, Diagnostic reagents, UV

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
GBZ 9-2002 Diagnostic Criteria of Occupational Acute Electric Ophthahlmia(Kerato-Conjunctivitis Caused by Ultraviolet Rays)

未注明发布机构, Diagnostic reagents, UV

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 15197:2004 Test systems for in vitro diagnostics – requirements for blood glucose measuring systems for self-use in diabetes mellitus

Lithuanian Standards Office , Diagnostic reagents, UV

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

GOSTR, Diagnostic reagents, UV

GOST R EN 13641-2010 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
GOST R 58569-2019 Kit for the animal’s brucellosis diagnosis by method of immunodiffusion. Specifications
GOST ISO 15197-2011 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Shanxi Provincial Standard of the People's Republic of China, Diagnostic reagents, UV

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

Indonesia Standards, Diagnostic reagents, UV

SNI ISO 19001:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
SNI ISO 15197:2009 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Professional Standard - Commodity Inspection, Diagnostic reagents, UV

SN/T 2435-2010 Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
SN/T 3451-2012 Technical specifications of quality control for diagnostic reagents in plant quarantine laboratory

American Society for Testing and Materials (ASTM), Diagnostic reagents, UV

ASTM D1768-89(1995)e1 Standard Test Method for Sodium Alkylbenzene Sulfonate in Synthetic Detergents by Ultraviolet Absorption

Canadian Standards Association (CSA), Diagnostic reagents, UV

CSA ISO 15197-05-CAN/CSA:2005 Syst鑝es d'essais de diagnostic in vitro ?Exigences relatives aux syst鑝es d'autosurveillance de la glyc閙ie destin閟 ?la prise en charge du diab鑤e sucr镻remi鑢e 閐ition

International Electrotechnical Commission (IEC), Diagnostic reagents, UV

IEC TS 62306:2006 Ultrasonics - Field characterisation - Test objects for determination temperature elevation in diagnostic ultrasonic fields