Classification of in vitro diagnostics

Classification of in vitro diagnostics, Total:393 items.

The international standard classification for "Classification of in vitro diagnostics" includes: Laboratory medicine , Diagnostic equipment , Veterinary medicine , Animal husbandry and breeding .

The Chinese standard classification for "Classification of in vitro diagnostics" includes: Medical laboratory equipment , Sanitation in general , Medical apparatus and devices in general , Animal quarantine, veterinary and epidemic prevention .

Professional Standard - Agriculture

159药典三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
178药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen 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)
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)
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum antibody diagnostic kit (enzyme-linked immunoassay)
160药典三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV 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)
181药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen 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
180药典三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus 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
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen 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
165药典三部-2015 Monograph IV In Vitro Diagnostic Anti-A Anti-B Blood Typing Reagents (Monoclonal Antibodies)
163药典三部-2015 Monograph ⅣIn vitro diagnosis of syphilitic rapid plasma reagin diagnostic reagents
183药典三部-2020 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum 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)
177药典三部-2020 Monograph III In Vivo Diagnosis of Sikh Test-like Toxins
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)
158药典三部-2015 Monograph III In Vivo Diagnosis of Sikh Test-like Toxins

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

Professional Standard - Hygiene

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

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

GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
GB/T 29791.5-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 5:In vitro diagnostic instruments for selftesting
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 32945-2016 Bovine tuberculosis diagnosis--Assay on IFN-γ in vitro
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB/T 29791.2-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use

Professional Standard - Medicine

YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
YY/T 1244-2014 Purified water for in vitro diagnostic reagents
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 1151-2009 Protein microarray for in vitro diagnostics
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing

未注明发布机构

DIN EN ISO 4307:2022 Molecular analytical in vitro diagnostic procedures – Specifications for pre-analytical processes for saliva – Isolated human DNA
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 ISO 18113-5:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-2:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-3:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
DIN CEN/TS 17626:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use
DIN EN ISO 18113-1:2010 In vitro diagnostic medical devices Information provided by the manufacturer
DIN EN ISO 18113-4:2010 In vitro diagnostic medical devices — information provided by the manufacturer

国家药监局

YY/T 1789.2-2021 In vitro diagnostic test systems-Performance evaluation method-Part 2:Trueness
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 1789.1-2021 In vitro diagnostic test systems-Performance evaluation method-Part 1:Precision
YY/T 1652-2019 General technical requirements of quality control materials for in vitro diagnostic reagents

Group Standards of the People's Republic of China

T/CI 310-2024 Performance evaluation of blockers in raw materials for in vitro diagnostic products
T/SZZX 014-2023 Probes for in-vitro diagnostic medical devices
T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
T/SAMD 0002-2023 Probes for in-vitro diagnostic medical devices
T/CAMDI 125-2024 Reliability test methods for in vitro diagnostic (IVD) medical equipment
T/ZMDS 40001-2021 Guidelines for values assignment of calibrator of IVD
T/NAHIEM 36-2021 In-vitro diagnostic management (distribution) enterprise group standards

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

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4000-2021 Diagnostic technique for Bovine Tuberculosis by interferon-gamma ELISA assay

Professional Standard - Aquaculture

SC/T 7204.1-2007 Diagnostic Protocols for Taura Syndrome of Penaeid Shrimp - Part 1: Gross Signs Method

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

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
NS-EN 592:1994 In vitro diagnostic systems — Requirements for user manual for in vitro diagnostic instruments for home use
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN 591:1994 In vitro diagnostic systems — Requirements for user manuals for in vitro diagnostic instruments for professional use
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)
NS-EN ISO 23640:2013 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
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
NS-EN 1658:1996 Requirements for marking of in vitro diagnostic instruments
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 18113-3:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
DANSK DS/EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
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 13640:2002 Stability testing of in vitro diagnostic reagents
DANSK DS/EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
AENOR UNE-EN 1658:1997 Marking requirements for in vitro diagnostic instruments.
BS EN ISO 18113-5:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
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
BS PD CEN/TS 17305:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
DANSK DS/CEN/TS 17305:2019 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA
SN-CEN/TS 17305:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
BS PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows-Human DNA examination
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
BS PD CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows-Human RNA examination
NS-EN 928:1995 In vitro diagnostic systems — Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
UNE-EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing.
NS-EN ISO 18113-5:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
DANSK DS/CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows – Part 2: Human RNA examination
DIN CEN/TS 17981-2:2024 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination; German version CEN/TS 17981-2:2023
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
DIN CEN/TS 17981-1:2024 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination; German version CEN/TS 17981-1:2023
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 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)
DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
UNE-EN 13640:2002 Stability testing of in vitro diagnostic reagents.
DANSK DS/CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows – Part 1: Human DNA examination
NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
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
UNE-EN 12376:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
NS-EN ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
NS-EN ISO 18113-3:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
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)
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
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)
UNE-EN ISO 18113-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
AENOR UNE-EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
NS-EN ISO 18113-3:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
AENOR UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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)
BS EN 376:1992 Specification for labelling of in vitro diagnostic reagents for self-testing
UNE-EN ISO 18113-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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)
DANSK DS/EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
DANSK DS/EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
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 ISO 18113-5:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
NS-EN ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
NS-EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
BS EN 375:1992 Specification for labelling of in vitro diagnostic reagents for professional use
AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
NS-EN 591:2001 Instructions for use for in vitro diagnostic instruments 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
BS EN 592:1995 Specification for user manuals for in vitro diagnostic instruments for home use
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)
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
DANSK DS/ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA
DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
BS EN 591:1995 Specification for user manuals for in vitro diagnostic instruments for professional use
UNE-EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use.
06/30146515 DC BS ISO 18113-2. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
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
06/30146522 DC BS ISO 18113-4. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
06/30146518 DC BS ISO 18113-3. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
AENOR UNE-EN 928:1996 In vitro diagnostic systems. Guidelines for the application of Standards EN 29001 and EN 46001, and Standards EN 29002 and EN 46002 to medical devices for in vitro diagnostics.
06/30146526 DC BS ISO 18113-5. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
DANSK DS/EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
BS PD CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue-Isolated DNA
BS PD CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue-Isolated DNA
DIN EN 18000-1 E:2023 Draft Document - 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
NS-EN ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA (ISO 4307:2021)
DANSK DS/EN ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA (ISO 4307:2021)
BS PD CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue-Isolated proteins
SN-CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
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
DIN EN ISO 18113-3 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2006); German version prEN ISO 1...

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 18113-5-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
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 18113-3-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS P 1800-2013 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS P 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
KS P ISO TR 18112-2020 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 manufacturer
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

British Standards Institution (BSI)

BS EN ISO 23640:2011 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 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
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 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
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 18113-5:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments 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 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 4307:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
BS EN ISO 18113-3:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments 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
PD CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human RNA examination
PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human DNA examination
BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
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
21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments 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 13612:2002 Performance evaluation of in vitro diagnostic medical devices
BS EN 1658:1997 Requirements for marking of in vitro diagnostic instruments
21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing
BS EN 13612:2002(2003) Performance evaluation of in vitro diagnostic medical devices
BS EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
21/30421396 DC BS EN ISO 4307. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
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 ISO 6717:2021 In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
BS EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated RNA
23/30478367 DC BS EN 18000-1. Animal health diagnostic analyses. Control of in vitro diagnostic reagents - Part 1. Application file for the initial and the batch-to-batch control
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
BS EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated DNA
BS EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
BS EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
BS ISO 21474-2:2022 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification

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 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
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 4307:2022-02 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021); German version EN ISO 4307:2021
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 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
DIN EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021); German and English version prEN ISO 4307:2021
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 18000-1:2023 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
DIN EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013
DIN EN ISO 18113-3:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 / Note: DIN EN ISO 18113-3 (2010-05) remain...
DIN EN ISO 18113-1:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 / Note: Date of issue 2021-08-06*I...
DIN EN ISO 18113-1:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 / Note: DIN EN ISO 18113-1 (2010-05) remains valid a...
DIN EN ISO 18113-4:2013-01 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 / Note: DIN EN ISO 18113-4 (2010-05) remains valid...
DIN EN ISO 18113-3:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 / Note: Date of issue 202...
DIN EN ISO 18113-5:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021 / Note: Date of issue 2021-08...
DIN EN ISO 18113-2:2021-09 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); German and English version prEN ISO 18113-2:2021 / Note: Date of issue 2021-0...
DIN EN ISO 18113-4:2021-09 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); German and English version prEN ISO 18113-4:2021 / Note: Date of issue 2021-08-06...
DIN EN ISO 18113-5:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 / Note: DIN EN ISO 18113-5 (2010-05) remains va...
DIN EN ISO 18113-5:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011
DIN EN ISO 18113-3:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
DIN EN ISO 18113-2:2013-01 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 / Note: DIN EN ISO 18113-2 (2010-05) remains v...
DIN EN 1659:1997 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions; German version EN 1659:1996
DIN CEN/TS 17626:2022-01 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA; German version CEN/TS 17626:2021
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

International Organization for Standardization (ISO)

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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 18113-4:2022 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 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments 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 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO/DIS 15193:2024 In vitro diagnostic medical devices — Requirements for reference measurement procedures

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 S92-017:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUALS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE. (EUROPEAN STANDARD EN 592).
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 S92-010:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 375).
NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF S92-010-4*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 S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
NF S92-010-5*NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing
NF S92-010-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use.
NF S92-040:1999 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.
NF S92-010-3*NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments 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 18113-2:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 2: in vitro diagnostic reagents for professional use
NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 3: in vitro diagnostic instruments for professional use
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 18113-5:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 5: in vitro diagnostic instruments for self-testing
NF EN ISO 4307:2021 In Vitro Molecular Diagnostic Assay - Preanalytical Process Specifications for Saliva - Extracted Human DNA
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 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
NF S92-031:1996 In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.
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 S92-076*NF EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF C74-336:1988 Medical electrical equipment. Ultrasound equipment for diagnostic. Classification of specified diagnostic applications.
NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for collecting samples of human origin other than blood
NF EN 14136:2004 Use of external quality assessment programs in evaluating the performance of in vitro diagnostic procedures

ES-UNE

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN ISO 4307:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.

KR-KS

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
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

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 18113-3:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
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 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021)

BE-NBN

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

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 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 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
prEN 928-1992 In vitro diagnostic systems; guidance on the application of EN 29001/EN 46001 and EN 29002/EN 46002 for the in vitro diagnostics industry
EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
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)
CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
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)
FprEN ISO 18113-3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
EN ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing [Superseded: CEN EN 592]
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 18113-3:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
EN ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use [Superseded: CEN EN 591]
EN 928:1995 In Vitro Diagnostic Systems - Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in Vitro Diagnostic Medical Devices
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)
prEN ISO 18113-5:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
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 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA

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 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
DS/ISO 4307:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA
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/CEN/TS 17626:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for human specimen – Isolated microbiome DNA

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 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
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 ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
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 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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.

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

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 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 18113-5-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
GOST R ISO 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments 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 51352-2013 In vitro diagnostic medical devices. Test methods

GSO

BH GSO ISO 18113-3:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
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 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
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
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 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
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
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 18113-5:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
GSO ISO 18113-5:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
BH GSO ISO 18113-5:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments 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
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing

CEN - European Committee for Standardization

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
PD CEN/TS 17305:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
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

GOST

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

Lithuanian Standards Office

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 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 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 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R EN 592-2010 Instructions for use for in vitro diagnostic instruments for self-testing
GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

Society of Automotive Engineers (SAE)

SAE J1939/13-2011 Off-Board Diagnostic Connector
SAE J1939/13-1999 Off-Board Diagnostic Connector
SAE J1939/13-2016 Off-Board Diagnostic Connector

SAE - SAE International

SAE J1939-13-2011 Off-Board Diagnostic Connector
SAE J1939-13-2016 Serial Control and Communications Heavy Duty Vehicle Network - Top Level Document (See SAE CS 1939 for Companion Spreadsheet)
SAE J1939-13-1999 Off-Board Diagnostic Connector
SAE J1939-13-1998 Off-Board Diagnostic Connector
SAE J1939-13-2004 Off-Board Diagnostic Connector

Japanese Industrial Standards Committee (JISC)

JIS L 1918:2005 Testing for skin primary irritation on textile products-in vitro human skin model method
JIS L 1918:2011 Testing for skin primary irritation on textile products -- in vitro human skin model method

US-CFR-file

CFR 21-801.119-2013 Food and Drugs. Part801:Labeling. Section801.119:In vitro diagnostic products.