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A class of in vitro diagnostic reagents

A class of in vitro diagnostic reagents, Total:155 items.

In the international standard classification, A class of in vitro diagnostic reagents involves: Company organization and management, Medical sciences and health care facilities in general, Laboratory medicine, Analytical chemistry, Medical equipment.

Korean Agency for Technology and Standards (KATS), A class 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 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 ISO TS 17822-1:2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi

KR-KS, A class 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 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 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
KS P ISO TS 17822-1-2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi
KS P ISO 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

ES-UNE, A class 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, A class 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 S92-032:2002 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 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 S92-036:2004 In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans.
NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang
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 S92-012*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 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 ...

German Institute for Standardization, A class 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 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 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 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 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
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

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

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

Professional Standard - Agriculture, A class 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)
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)
137药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis rapid plasma reagin diagnostic reagents
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum antibody diagnostic kit (enzyme-linked immunoassay)
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)
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)
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
134药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis C 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)
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)
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
139药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic anti-A anti-B blood typing reagent (monoclonal antibody)
140药典三部-2010 Chapter Ⅳ In vitro diagnostic anti-A and anti-B blood typing reagents (human serum)
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
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

Group Standards of the People's Republic of China, A class 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

European Committee for Standardization (CEN), A class 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 375:1992 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 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 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 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

Danish Standards Foundation, A class 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, A class of in vitro diagnostic reagents

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

AENOR, A class 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 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
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)

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

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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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 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 ISO 6717:2021 Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
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 ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, A class 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

RU-GOST R, A class 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

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

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

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

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

国家药监局, A class 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

International Organization for Standardization (ISO), A class 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 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
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 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

CEN - European Committee for Standardization, A class 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

中华人民共和国国家卫生和计划生育委员会, A class 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, A class 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

Lithuanian Standards Office , A class of in vitro diagnostic reagents

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)

AT-ON, A class 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)
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, A class of in vitro diagnostic reagents

GOST R EN 13641-2010 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

Shanxi Provincial Standard of the People's Republic of China, A class 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