In vitro diagnostic reagent naming

In vitro diagnostic reagent naming, Total:206 items.

The international standard classification for "In vitro diagnostic reagent naming" includes: Laboratory medicine , Diagnostic equipment .

The Chinese standard classification for "In vitro diagnostic reagent naming" includes: Medical laboratory equipment , Medical apparatus and devices in general , Sanitation in general .

Professional Standard - Medicine

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

国家药品监督管理局

YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro 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 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

Professional Standard - Agriculture

178药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
164药典三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum 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)
180药典三部-2020 Monograph 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)
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
162药典三部-2015 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
161药典三部-2015 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
179药典三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
184药典三部-2020 Monograph IV In Vitro Diagnostic Anti-A Anti-B Blood Typing Reagents (Monoclonal Antibodies)
159药典三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
137药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis of syphilis rapid plasma reagin diagnostic reagents
160药典三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV 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)
183药典三部-2020 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum 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)
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents

国家发展和改革委员会

WB/T 1116-2020 Mezzanine rack

Professional Standard - Goods and Materials

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

Group Standards of the People's Republic of China

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
T/CI 310-2024 Performance evaluation of blockers in raw materials for in vitro diagnostic products

未注明发布机构

DIN EN 376:2002 Provision of information by the manufacturer of reagents for in-vitro diagnostic tests for self-use
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)

国家药监局

YY/T 1652-2019 General technical requirements of quality control materials for in vitro diagnostic reagents
YY/T 1709-2020 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
YY/T 0639-2019 In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

中华人民共和国国家卫生和计划生育委员会

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

Shanxi Provincial Standard of the People's Republic of China

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

Professional Standard - Hygiene

WS/T 252-2005 Labeling of In Vitro Diagnosis Products

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 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 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 23640:2012 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 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

SCC

NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents
DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2011 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)
09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing of in vitro diagnostic reagents
NS-EN ISO 23640:2013 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.
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
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 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
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
NS-EN 12376:1999 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
UNE-EN 12376:1999 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/EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
DANSK DS/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
NS-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
NS-EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
AENOR UNE-EN 12376:1999 Medical products for in vitro diagnosis. Information provided by the manufacturer with in vitro diagnostic reagents used for staining in biology.
NS-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)
10/30228700 DC BS EN ISO 19001. In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
AENOR 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 375:2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE.
NS-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)
NS-EN 592:1994 In vitro diagnostic systems — Requirements for user manual for in vitro diagnostic instruments for home use
UNE-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 (ISO 18113-2:2009)
NS-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 (ISO 18113-2:2009)
NS-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)
NS-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 (ISO 18113-4:2009)
AENOR 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)
DIN EN ISO 19001 E:2010 Draft Document - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO/DIS 19001:2010); German version prEN ISO 19001:2010
AENOR UNE-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE-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 (ISO 18113-4:2009)
NS-EN 591:1994 In vitro diagnostic systems — Requirements for user manuals for in vitro diagnostic instruments for professional use
NS-EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
UNE-EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.

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 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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 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 18113-4-2015(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

KR-KS

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

ES-UNE

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

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
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 18113-4:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing
BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
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 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
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 375:2001 Information supplied by the manufacturer with 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 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 18113-5:2011 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

Association Francaise de Normalisation

NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability 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 S92-032:2002 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 S92-040:1999 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 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 In vitro diagnostic medical devices - Information provided by the manufacturer with in vitro diagnostic staining reagents used in biology
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 S92-010-4:2010 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 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
NF S92-017:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUALS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE. (EUROPEAN STANDARD EN 592).
NF EN 13641:2002 Elimination or reduction of the risk of infection relating to in vitro diagnostic reagents
NF S92-016:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIRMENTS FOR USER MANUELS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 591).
NF S92-041*NF EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
NF EN ISO 10365:2022 Adhesives - Designation of the main rupture facies

European Committee for Standardization (CEN)

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 ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
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)
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)
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)
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 375:2001 Information Supplied by the manufacturer with 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
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 592:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or home use
DS/EN 591:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or professional use

GOST

GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents

AENOR

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)

International Organization for Standardization (ISO)

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 10365:1992 Adhesives; designation of the main failure patterns

AT-ON

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
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)

RU-GOST R

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 18113-2-2015 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 4.389-1985 Product-quality index system. Medical ultrasonic diagnostic instruments. Index nomenclature
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods

BE-NBN

NBN-EN 376-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
NBN EN 591-1995 In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
NBN EN 592-1995 In vitro diagnostic systems - Requirements for user manual for in vitro diagnostic instruments for home use

GSO

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 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
OS GSO ISO 18113-4:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
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
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
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
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

BSI

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
DANSK DS/ISO 18113-2:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use

CEN - European Committee for Standardization

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

Society of Automotive Engineers (SAE)

SAE J2403-1998 Medium/Heavy-Duty E/E Systems Diagnosis Nomenclature

Lithuanian Standards Office

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

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

US-FCR

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