Diagnostic reagent series

Diagnostic reagent series, Total:223 items.

The international standard classification for "Diagnostic reagent series" includes: Laboratory medicine , Diagnostic equipment , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Diagnostic reagent series" includes: Medical laboratory equipment , Medical apparatus and devices in general , Medical science , Sanitation in general .

Professional Standard - Medicine

YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
YY/T 1244-2014 Purified water for in vitro diagnostic reagents
YY/T 1220-2013 (Creatine kinase isoenzyme MB)(CK-MB) diagnostic kit(Colloid gold method)
YY/T 1789.6-2023 In vitro diagnostic test systems―Performance evaluation method―Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 1956-2025 Terms and definitions for clinical trials of in vitro diagnostic reagents
YY/T?1956-2025 Terminology and Definitions for Clinical Trials of In Vitro Diagnostic Reagents
YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents
YY/T 1221-2013 Cardiac troponiniⅠ(cTnI ) diagnostic kit(Colloid gold method)
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 1652-2019 General technical requirements of quality control materials for 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 1709-2020 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits

Professional Standard - Agriculture

134兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit
159药典三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
160药典三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
179药典三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV 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)
135兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum 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)
162药典三部-2015 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
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
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
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
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
135药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic human immunodeficiency virus antibody diagnostic kit (enzyme-linked immunoassay)
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
180药典三部-2020 Monograph 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)
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
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
164药典三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
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
181药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen 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)
137药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis rapid plasma reagin diagnostic reagents

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

GB/T 29791.2-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use
GB/T 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

Professional Standard - Hygiene

WS/T 336-2011 Diagnosis criteria for prostate cancer
WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline

Professional Standard - Goods and Materials

WB/T 1115-2021 Specification for in vitro diagnostic reagent temperature control logistics service
WB/T 1116-2020 Mezzanine rack

Group Standards of the People's Republic of China

T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents
T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
T/HZFDS 001-2025 Specification for evaluation of export quality management capabilities of in vitro diagnostic reagents

National Health Commission of the People's Republic of China

WST 336:2011 Prostate Cancer Diagnosis (Abolition)

National Metrological Technical Specifications of the People's Republic of China

JJF 1621-2017 Calibration Specification for Diagnostic Dosimeters

Professional Standard - Commodity Inspection

SN/T 2435-2010 Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine

Military Standard of the People's Republic of China-General Armament Department

GJB 3385A-2020 Terms for testing and diagnostics
GJB 3385-1998 Terms for testing and diagnostics

Standards Norway

NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN 12376:1999 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
NS-EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
NS-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents

European Committee for Standardization (CEN)

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
EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
CEN 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 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
prEN 592-1991 In-vitro diagnostic systems; requirements for user manual of in-vitro diagnostic instruments for home use
EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
prEN 591-1991 In-vitro diagnostic systems; requirements for user manual of in-vitro diagnostic instruments for professional use
prEN 406-1990 In-vitro diagnostic systems; definitions of disciplines
EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
EN 376:2002 Information Supplied by the Manufacturer with 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

Ente Nazionale Italiano di Unificazione

UNI EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use.
UNI EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN 376:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for self-testing.
UNI EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
UNI EN 13640:2002 Stability testing of in vitro diagnostic reagents
UNI EN ISO 18113-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self- testing
UNI EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
UNI EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
UNI 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
UNI EN 12376:2001 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
UNI EN 13641:2003 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
UNI EN ISO 18113-4:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
UNI EN ISO 18113-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
UNI 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

Danish Standards Foundation

DS/EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
DS/EN 376:1993 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
DANSK DS/EN 375:2001 Information supplied by the manufacturer with 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
DANSK DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DANSK DS/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
DANSK DS/ISO 18113-4:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing

Association Francaise de Normalisation

NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-010:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 375).
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 S92-040:1999 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.
NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information provided by the manufacturer with in vitro diagnostic staining reagents used in biology
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 S92-010-4*NF EN ISO 18113-4:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing
NF S92-010-2*NF EN ISO 18113-2:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
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 18113-2:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
NF EN ISO 18113-4:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing
NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 2: in vitro diagnostic reagents for professional use
NF EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
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

German Institute for Standardization

DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
DIN EN 18000-2:2023 Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023
DIN EN 18000-2 E:2023-10 Draft Document - Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023
DIN EN 18000-2 E:2023 Draft Document - Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023
DIN EN ISO 23640:2012-03 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DIN EN ISO 23640:2013-09 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DIN EN ISO 23640 E:2013-04 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN EN ISO 23640 E:2013 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN EN 12376:1999 In vitro diagnostic medical devices – Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DIN EN ISO 19001 E:2010-08 Information provided by manufacturers of in vitro diagnostic reagents for biocoloring of in vitro diagnostic medical devices (draft)
DIN EN 18000-3 E:2025-04 Draft Document - Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 3: Reagents for PCR techniques; German and English version prEN 18000-3:2025
DIN 6809-3:1990-03 Clinical dosimetry; diagnostic radiology
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 23640:2013 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 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 6809-3:1990 Clinical dosimetry; diagnostic radiology
DIN EN 12376:1999-04 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DIN EN 18000-3:2025-04 Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 3: Reagents for PCR techniques; German and English version prEN 18000-3:2025
DIN EN 376:2002 Provision of information by the manufacturer of reagents for in-vitro diagnostic tests for self-use
DIN EN 375:2001 Information provided by in vitro diagnostic reagent manufacturers for professional use

Korean Agency for Technology and Standards (KATS)

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640-2019(2024) In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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 19001:2010 In virto diagnostic medical devices－Information supplied by the manufacturer with in vitro gnostic reagents for staining in biology
KS P ISO 18113-4-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
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 18113-2-2023 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
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 18113-4-2024 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
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 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use

Spanish Association for Standardization (UNE)

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13640:2002 Stability testing 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)
AENOR UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 12376:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
UNE-EN 375:2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE.

Austrian Standards

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

British Standards Institution (BSI)

BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
25/30507115 DC BS EN 18000-3 Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 3: Reagents for PCR techniques
09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing of in vitro diagnostic reagents
23/30478370 DC BS EN 18000-2 Animal health diagnostic analyses. Control of in-vitro diagnostic reagents - Part 2. Reagents for immunological techniques
BS EN 376:1992 Specification for labelling of in vitro diagnostic reagents for self-testing
BS EN 375:1992 Specification for labelling of in vitro diagnostic reagents for professional use
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 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
BS EN ISO 18113-4:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
BS EN ISO 18113-4:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing
BS EN ISO 18113-2:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents 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
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 AU 206-2:1986 Diagnostic systems for road vehicles - Specification for graphical symbols for diagnostic testers
BS EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Bureau of Indian Standards

IS/ISO 23640-2011 In Vitro Diagnostic Medical Devices —— Evaluation of Stability of in vitro Diagnostic Reagents
IS 17718-2022 Performance Testing Of In-Vitro Diagnostics Ivd Reagent Kit Alpha - Amylase Cnp-G3 Liquid Stable Clinical Chemistry Reagents/ Kits

Gosstandart of Russia

GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents
GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
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 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
GOST R ISO 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 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R ISO 18113-2-2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use

Belgian Standards Institute

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

Swedish Institute for Standards

SS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
SS-ISO 14229:1999 Road vehicles - Diagnostic systems - Diagnostic services specification
SS-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
SS-EN 12376:1999 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
SS-ISO 8093:1988 Road vehicles - Diagnostic testing of electronic systems
SIS SS-ISO 8093:1988 Road vehicles - Diagnostic testing of electronic systems

Indonesia Standards

SNI ISO 23640:2018 In Vitro Diagnostic Medical Devices – Evaluation of the Stability of In Vitro Diagnostic Reagents (ISO 23640:2011, IDT)
SNI ISO 19001:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

International Organization for Standardization (ISO)

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO 14229:1998 Road vehicles - Diagnostic systems - Diagnostic services specification
ISO 19001:2002 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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

GCC Standardization Organization

GSO ISO 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
BH GSO ISO 18113-4:2024 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
GSO ISO 18113-4:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
GSO ISO 18113-3:2024 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
BH GSO ISO 18113-2:2024 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
GSO ISO 8093:2013 Road vehicles -- Diagnostic testing of electronic systems

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 18113-4:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
OS GSO ISO 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
OS GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
OS GSO ISO 8093:2013 Road vehicles -- Diagnostic testing of electronic systems

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 18113-4:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
BH GSO ISO 18113-2:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use

Japanese Industrial Standards Committee (JISC)

JIS D 5404:2000 Road vehicles -- Diagnostic systems -- Physical layer and diagnostic connector
JIS D 5404:2006 Road vehicles -- Diagnostic systems -- Physical layer and diagnostic connector