Analytical Testing In Vitro Diagnostic

Analytical Testing In Vitro Diagnostic, Total:387 items.

The international standard classification for "Analytical Testing In Vitro Diagnostic" includes: Laboratory medicine , Diagnostic equipment .

The Chinese standard classification for "Analytical Testing In Vitro Diagnostic" includes: Medical apparatus and devices in general , Medical laboratory equipment , Sanitation in general .

Professional Standard - Medicine

YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 1244-2014 Purified water for in vitro diagnostic reagents
YY/T 1789.5-2023 In vitro diagnostic test systems--Performance evaluation method一Part 5:Analytical specificity
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 1789.6-2023 In vitro diagnostic test systems―Performance evaluation method―Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 1153-2009 DNA microarray for in vitro diagnostics

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

GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1: Isolated RNA
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 19634-2005 In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 43279.1-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 1: Isolated cellular RNA
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 42080.2-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins
GB/T 32945-2016 Bovine tuberculosis diagnosis--Assay on IFN-γ in vitro
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 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

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

未注明发布机构

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 376:2002 Provision of information by the manufacturer of reagents for in-vitro diagnostic tests for self-use
DIN CEN/TS 17626:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
DIN EN ISO 4307:2022 Molecular analytical in vitro diagnostic procedures – Specifications for pre-analytical processes for saliva – Isolated human DNA
DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use

Professional Standard - Hygiene

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

Group Standards of the People's Republic of China

T/CI 019-2022 Technical Guidelines on Feline Rapid Diagnosis In Vitro （Fluorescence Immunochromatography）
T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）
T/CI 018-2022 Technical Guidelines on Canine Rapid Diagnosis In Vitro （Fluorescence Immunochromatography）

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

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 39367.1-2020 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 definitions

国家药监局

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 1789.2-2021 In vitro diagnostic test systems-Performance evaluation method-Part 2:Trueness
YY/T 1789.1-2021 In vitro diagnostic test systems-Performance evaluation method-Part 1:Precision
YY/T 1789.3-2022 In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation

Professional Standard - Agriculture

136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum 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)
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)

石家庄市市场监督管理局

DB1301/T 424-2022 Technical requirements for sample collection of gamma-interferon method for in vitro detection of bovine tuberculosis diagnosis

Taiwan Provincial Standard of the People's Republic of China

CNS 15035-2006 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

SCC

NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
UNE-EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing.
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 376:1992 Specification for labelling of in vitro diagnostic reagents for self-testing
NS-EN 592:2002 Instructions for use for in vitro diagnostic instruments 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 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
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
09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing of in vitro diagnostic reagents
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
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 18113-5:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
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
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 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 592:1994 In vitro diagnostic systems — Requirements for user manual for in vitro diagnostic instruments for home use
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
BS PD CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows-Human RNA examination
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
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/EN 13640:2002 Stability testing of in vitro diagnostic reagents
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)
DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
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
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
BS PD CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue-Isolated proteins
NS-EN 591:1994 In vitro diagnostic systems — Requirements for user manuals for in vitro diagnostic instruments for professional use
BS PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows-Human DNA examination
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 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)
SN-CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
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)
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)
NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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)
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)
UNE-EN 13640:2002 Stability testing of in vitro diagnostic reagents.
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
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
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
DANSK DS/CEN/TS 17626:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for human specimen – Isolated microbiome DNA
BS PD CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated cellular RNA
SN-CEN/TS 17305:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
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
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/CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows – Part 2: Human RNA examination
DANSK DS/CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows – Part 1: Human DNA examination
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 PD CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated genomic DNA
DANSK DS/ISO 21474-2:2022 In vitro diagnostic medical devices – Multiplex molecular testing for nucleic acids – Part 2: Validation and verification
SN-CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for FFPE tissue — Part 3: Isolated DNA
DANSK DS/CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA
SN-CEN/TS 16827-1:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for FFPE tissue — Part 1: Isolated RNA
DANSK DS/CEN/TS 16827-1:2015 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for FFPE tissue – Part 1: Isolated RNA
BS PD CEN/TS 17390-3:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood-Preparations for analytical CTC staining
NS-EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
DANSK DS/CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for snap frozen tissue – Part 3: Isolated DNA
BS PD CEN/TS 17688-2:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs)-Isolated proteins
BS PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs)-Isolated cellular RNA
DANSK DS/ISO 20184-1:2019 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 1: Isolated RNA
DANSK DS/CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for snap frozen tissue – Part 1: Isolated RNA
DANSK DS/ISO 20184-3:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA
SN-CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap frozen tissue — Part 1: Isolated RNA
SN-CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: 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
BS EN ISO 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
NS-EN 1658:1996 Requirements for marking of in vitro diagnostic instruments
BS EN ISO 18113-3:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
BS PD CEN/TS 17688-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs)-Isolated genomic DNA
DANSK DS/CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins
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
SN-CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins
DIN EN ISO 18113-4 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2006); German version prEN ISO 18113-4:...
AENOR UNE-EN 1658:1997 Marking requirements for in vitro diagnostic instruments.
DANSK DS/CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for snap frozen tissue – Part 2: Isolated proteins
DIN EN ISO 18113-5 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2006); German version prEN ISO 18113...
DANSK DS/CEN/TS 17811:2022 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for urine and other body fluids – Isolated cell free DNA
SN-CEN/TS 17811:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
CSA ISO 20186-1:2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
BS PD CEN/TS 17811:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
SN-CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap frozen tissue — Part 2: Isolated proteins
DANSK DS/ISO 20186-1:2019 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 1: Isolated cellular RNA
AENOR UNE-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DANSK DS/CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 1: Isolated cellular RNA
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
DANSK DS/EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
NS-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DANSK DS/ISO 20186-2:2019 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 2: Isolated genomic DNA
SN-CEN/TS 17747:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
DANSK DS/CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 2: Isolated genomic DNA
BS PD CEN/TS 16945:2016 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
DIN CEN/TS 17688-1:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA; German version CEN/TS 17688-1:2021
DANSK DS/CEN/TS 17688-2:2022 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) – Part 2: Isolated proteins
SN-CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
CSA ISO 20186-2:2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
DANSK DS/CEN/TS 17688-1:2022 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) – Part 1: Isolated cellular RNA
BS PD CEN/TS 17747:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins
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
DIN CEN/TS 17688-2:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins; German version CEN/TS 17688-2:2021

Danish Standards Foundation

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 592:1995 In vitro diagnostic systems - Requirements for ser manuals for in vitro diagnostic instruments or home use
DS/CEN/TS 17626:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for human specimen – Isolated microbiome DNA
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/ISO 20184-3:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA
DS/EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA (ISO 20184-3:2021)

AT-ON

ONORM EN 376-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing
ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use
OENORM EN ISO 18113-4:2021 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)
ONR CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
OENORM EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021)

KR-KS

KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 16256-2017 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
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 20186-1-2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA

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

European Committee for Standardization (CEN)

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 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
CEN/TS 17626:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
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 ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
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 18113-5:2021 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)
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)
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 18113-4:2011 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 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing [Superseded: CEN EN 592]
EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
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
CEN/TS 17811:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
prEN ISO 18704 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
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)
CEN/TS 17747:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
prCEN ISO/TS 18702 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
EN ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003

Korean Agency for Technology and Standards (KATS)

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 18113-4-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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 ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P 1977-2018 Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
KS P 1975-2018 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
KS P ISO 21474-2-2023 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
KS P ISO 16256:2017 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
KS P 1975-2023 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
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 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
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

British Standards Institution (BSI)

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 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 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated RNA
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 ISO 21474-2:2022 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification
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 20184-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated DNA
PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human DNA examination
PD CEN/TS 17981-2:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human RNA examination
BS PD CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins
BS EN ISO 4307:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
BS EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteins
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
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 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
BS PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
BS EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated genomic DNA
BS PD CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated RNA
BS PD CEN/TS 16827-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE 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
PD CEN/TS 17390-3:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining
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
PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated cellular RNA
PD CEN/TS 17688-2:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated proteins
BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
PD CEN/TS 17688-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated genomic DNA
PD CEN/TS 17811:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
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 20184-2:2018(2019) Molecular in vitro diagnostic examinations - Specifications for pre - examination processes for frozen tissue Part 2 : Isolated proteins
21/30421396 DC BS EN ISO 4307. 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
BS EN ISO 23118:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
PD CEN/TS 17747:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins
PD ISO/TS 17822-1:2014 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens. General requirements, ...

GSO

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
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
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
GSO ISO 20184-3:2023 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
GSO ISO 20184-1:2023 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
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
BH GSO ISO 20184-1:2023 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
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
BH GSO ISO 20184-3:2023 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
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
GSO ISO 20186-1:2024 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA

German Institute for Standardization

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 23640:2015-12 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 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
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 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 20184-1:2019-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018); German version EN ISO 20184-1:2018
DIN EN ISO 20184-3:2021-11 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021); German version EN ISO 20184-3:2021
DIN CEN/TS 17811:2022-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA; German version CEN/TS 17811:2022
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 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 20184-2:2019-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018); German version EN ISO 20184-2:2018
DIN EN ISO 20186-1:2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
DIN EN ISO 20186-2:2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019); German version EN ISO 20186-2:2019
DIN CEN/TS 17688-2:2022-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins; German version CEN/TS 17688-2:2021
DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
DIN CEN/TS 17747:2022-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins; German version CEN/TS 17747:2022

GOSTR

GOST R EN 592-2010 Instructions for use for in vitro diagnostic instruments for self-testing
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

Association Francaise de Normalisation

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 18113-4:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
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 EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF EN ISO 4307:2021 In Vitro Molecular Diagnostic Assay - Preanalytical Process Specifications for Saliva - Extracted Human DNA
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 S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
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 S92-010-5*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 S92-016:1995 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 S92-076*NF EN ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF ISO 21474-2:2022 In vitro diagnostic medical devices - Multiplex molecular tests for nucleic acids - Part 2: validation and verification
NF EN ISO 20184-3:2021 In vitro molecular diagnostic assays - Specifications for preanalytical processes for frozen tissues - Part 3: Extracted DNA
NF EN ISO 23118:2021 In Vitro Molecular Diagnostic Assays - Preanalytical Process Specifications for Metabolome Analysis in Urine and Venous Blood (Serum and Plasma)
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 EN ISO 20184-1:2018 In vitro molecular diagnostic assays - Preanalytical process specifications for frozen tissues - Part 1: Extracted RNA
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 S92-070-1*NF EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1 : isolated RNA
NF EN ISO 20166-4:2021 In vitro molecular diagnostic assays - Specifications for preanalytical processes for formalin-fixed, paraffin-embedded (FFPE) tissues - Part 4: in situ detection techniques
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 S92-070-3*NF EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3 : isolated DNA
NF EN ISO 20186-1:2019 In vitro molecular diagnostic assays - Specifications for preanalytical processes for venous whole blood - Part 1: Extracted cellular RNA
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 EN ISO 20184-2:2018 In vitro molecular diagnostic assays - Preanalytical process specifications for frozen tissues - Part 2: extracted proteins
NF S92-040*NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
NF S92-031:1996 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 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 19001:2013 In vitro diagnostic medical devices - Information provided by the manufacturer with in vitro diagnostic staining reagents used in biology
NF S92-070-2*NF EN ISO 20184-2:2018 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2 : isolated proteins
NF S92-075-1*NF EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
XP S92-075-1*XP CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

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 18113-5:2009 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 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
ISO/DIS 21474-3:2024 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports
ISO 20184-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
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 18113-3:2022 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 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA
ISO 20186-1:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
ISO 20184-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
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 20186-2:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

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 ISO 20184-3:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
UNE-EN ISO 20184-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
UNE-EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
UNE-EN ISO 20184-2:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
UNE-CEN/TS 17688-2:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-CEN/TS 17747:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (Endorsed by Asociación Española de Normalización in June of 2022.)
UNE-EN ISO 20186-2:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)

GOST

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

RU-GOST R

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 18113-4-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
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 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
GOST R ISO 20184-2-2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Part 2. Isolated proteins

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 18113-5:2012 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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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

CEN - European Committee for Standardization

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
EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
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
EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

Lithuanian Standards Office

LST CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
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)

IT-UNI

UNI CEN/TS 17626-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
UNI EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA

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

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ASHRAE 4589-2002 The Use of Time Series Analysis in Fault Detection and Diagnosis Methodologies

Others: In Vitro Diagnostic Portable Analyzer,In vitro diagnostic microbiological testing,A kind of in vitro diagnostic analysis system,Analytical Testing In Vitro Diagnostic,Microbiological detection in vitro diagnostics,Basic requirements for in vitro diagnostic medical devices for self-testing,In vitro diagnostic analysis,Nucleic acid detection in vitro diagnostics