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Reference method for in vitro diagnostics

Reference method for in vitro diagnostics, Total:260 items.

In the international standard classification, Reference method for in vitro diagnostics involves: Laboratory medicine, Medical sciences and health care facilities in general, Medical equipment, Farming and forestry, Measurement of volume, mass, density, viscosity, Milk and milk products, Air quality, Textile fibres, Products of the textile industry, Construction materials, Microbiology, Testing of metals, Industrial automation systems, Non-destructive testing, Applications of information technology, Continuous handling equipment, Fuels, Petroleum products in general, Fluid storage devices, Ceramics, Company organization and management, Metrology and measurement in general, Non-textile floor coverings.

BE-NBN, Reference method for in vitro diagnostics

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

European Committee for Standardization (CEN), Reference method for in vitro diagnostics

EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
CEN/TS 17405:2020 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry
EN ISO 20776-1:2020 Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi
EN 14789:2005 Stationary source emissions - Determination of volume concentration of oxygen (O2) - Reference method - Paramagnetism
EN 14789:2017 Stationary source emissions - Determination of volume concentration of oxygen - Standard reference method: Paramagnetism
EN 480-15:2023 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures
EN ISO 18134-1:2022 Solid biofuels - Determination of moisture content - Part 1: Reference method (ISO 18134-1:2022)
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
EN 15058:2006 Stationary source emissions Determination of the mass concentration of carbon monoxide (CO) Reference method: Non-dispersive infrared spectrometry
EN ISO 18134-1:2015 Solid biofuels - Determination of moisture content - Oven dry method - Part 1: Total moisture - Reference method (ISO 18134-1:2015)

PT-IPQ, Reference method for in vitro diagnostics

NP EN 12286-2000 In vitro diagnostic medical devices Measurement of quantities in samples of boilogical origin Presentation of reference measurement procedures

Korean Agency for Technology and Standards (KATS), Reference method for in vitro diagnostics

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 1800-2013 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS P 1015-2018 Establishment of a reference material and evaluation method for troponin-based cardiovascular diagnostics
KS P ISO 15193-2014(2019) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
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
KS P ISO 15193:2010 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Requirements for content and presentation of reference measurement procedures
KS P ISO 15193:2014 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
KS H ISO 6734-2006(2016) Sweetened condensed milk -- Determination of total solids content(Reference method)
KS P ISO TS 17822-1:2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi
KS H ISO 13366-1:2006 Milk－Enumeration of somatic cells－Part 1：Microscopic method
KS B 0533-1995 Methods for measurement on ultrasonic velocity of solid by pulse technique using reference test pieces
KS B ISO 15704-2004(2009) Industrial automation systems－Requirements for enterprise-reference architectures and methodologies
KS B 0533-2005(2010) Methods for measurement on ultrasonic velocity of solidby pulse technique using reference test pieces
KS P 2094-2020 Protocol for measurement procedures comparison and bias estimation using patient samples in in-vitro diagnostic medical laboratory
KS B ISO 15704:2004 Industrial automation systems-Requirements for enterprise-reference architectures and methodologies
KS I ISO 21258:2022 Stationary source emissions — Determination of the mass concentration of dinitrogen monoxide(N2O) — Reference method: Non-dispersive infrared method

KR-KS, Reference method for in vitro diagnostics

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 16256-2022 Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infec
KS P ISO TS 17822-1-2018 In vitro diagnostic test systems ─ Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens ─ Part 1: General requirements, terms and defi
KS I ISO 21258-2022 Stationary source emissions — Determination of the mass concentration of dinitrogen monoxide(N2O) — Reference method: Non-dispersive infrared method

RU-GOST R, Reference method for in vitro diagnostics

GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST EN 14136-2016 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
GOST R 59551-2021 Seed potatoes. Sampling and methods of diagnostics of phytopathogens
GOST R ISO 16256-2015 Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GOST ISO 6731/IDF 21-2012 Milk, cream and evaporated milk. Determination of total solids content (Reference method)
GOST R 54186-2010 Solid biofuels. Determination of moisture content by oven dry method. Part 1. Total moisture. Reference method
GOST R 54186-2010(2019) Solid biofuels. Determination of moisture content by oven dry method. Part 1. Total moisture. Reference method
GOST R 54231-2010 Solid recovered fuels. Determination of moisture content using the oven drying. Part 1. Total moisture. Reference method
GOST R 54231-2010(2019) Solid recovered fuels. Determination of moisture content using the oven drying. Part 1. Total moisture. Reference method
GOST R 8.604-2004 State system for ensuring the uniformity of measurements. Medical diagnostic ultrasonic equipment. Portable foetal heartbeat detectors. General requirements for the declaration of parameters and measurement methods
GOST 8.627-2013 State system for ensuring the traceability of measurements. In vitro diagnostics medicine test systems for measurement of quantities in biological samples. Part 1. Haematology analyzers. Verification procedure

Professional Standard - Hygiene , Reference method for in vitro diagnostics

WS/T 253-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials
WS/T 254-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Presentation of reference measurement procedures

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Reference method for in vitro diagnostics

GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures
GB/T 18757-2002 Industrial automation systems--Requirements for enterprise-reference architectures and methodology
GB/T 18757-2008 Enterprise Reference Architecture and Methodology Requirements for Industrial Automation Systems

国家药监局, Reference method for in vitro diagnostics

YY/T 1728-2021 Reference method for in vitro activity testing of yeast-like fungal antimicrobials related to systemic infectious diseases for clinical laboratory testing and in vitro diagnostics
YY/T 1789.6-2023 In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 1789.1-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 1: Precision
YY/T 1789.2-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy
YY/T 1789.5-2023 Methods for performance evaluation of in vitro diagnostic test systems Part 5: Analytical specificity
YY/T 1789.3-2022 In vitro diagnostic testing system performance evaluation methods Part 3: Detection limit and quantitation limit
YY/T 1789.4-2022 In vitro diagnostic testing system performance evaluation methods Part 4: Linear intervals and reportable intervals

CEN - European Committee for Standardization, Reference method for in vitro diagnostics

EN 12287:1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials
EN 12286:1998 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures (Incorporates Amendment A1: 2000)
EN ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim
EN ISO 20166-2:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins
PD CEN/TS 14774-1:2004 Solid biofuels - Methods for determination of moisture content - Oven dry method - Part 1: Total moisture - Reference method
PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

British Standards Institution (BSI), Reference method for in vitro diagnostics

BS EN 12286:1999(2001) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS EN 12286:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS EN ISO 16256:2021 Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
BS EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
BS EN ISO 13366-1:2008 Milk - Enumeration of somatic cells - Microscopic method (Reference method)
BS EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
21/30442376 DC BS EN 480-1. Admixtures for concrete, mortar and grout. Test methods. Part 1. Reference concrete and reference mortar for testing
DD CEN/TS 14774-1:2004 Solid biofuels - Methods for determination of moisture content - Oven dry method - Part 1: Total moisture - Reference method
BS 2000-0-2:1996 Methods of test for petroleum and its products. General introduction. Specifications for IP standard reference liquids
21/30442373 DC BS EN 480-15. Admixtures for concrete, mortar and grout. Test methods. Part 15. Reference concrete and method for testing viscosity modifying admixtures
BS 7723-2:1994 Methods for calibration of vertical cylindrical tanks for petroleum and liquid petroleum products. Optical-reference-line method
BS EN 480-13:2015 Tracked Changes. Admixtures for concrete, mortar and grout. Test methods. Reference masonry mortar for testing mortar admixtures
BS EN 14789:2017 Tracked Changes. Stationary source emissions. Determination of volume concentration of oxygen. Standard reference method: Paramagnetism
PD ISO/TS 5798:2022 In vitro diagnostic test systems. Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
BS EN 15058:2017 Tracked Changes. Stationary source emissions. Determination of the mass concentration of carbon monoxide. Standard reference method: non-dispersive infrared spectrometry

AENOR, Reference method for in vitro diagnostics

UNE-EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
UNE-EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
UNE-EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
UNE-EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim
UNE-EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE 34868:1986 ICE-CREAM AND MILK ICE. DETERMINATION OF TOTAL SOLIDS. REFERENCE METHOD.
UNE 26191:1983 ROAD VEHICLES. LUGGAGE COMPARTEMENT OF PASSENGER. METHOD OF MEASURING THE REFERENCE VOLUME.
UNE-EN 480-1:2015 Admixtures for concrete, mortar and grout - Test methods - Part 1: Reference concrete and reference mortar for testing
UNE-EN ISO 13366-1:2008 Milk - Enumeration of somatic cells - Part 1: Microscopic method (Reference method) (ISO 13366-1:2008)
UNE-EN ISO 5534:2004 Cheese and processed cheese - Determination of total solids content (Reference method) (ISO 5534:2004)
UNE-EN 480-15:2013 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures
UNE-EN 14789:2017 Stationary source emissions - Determination of volume concentration of oxygen - Standard reference method: Paramagnetism
UNE-EN 15058:2017 Stationary source emissions - Determination of the mass concentration of carbon monoxide - Standard reference method: non-dispersive infrared spectrometry
UNE-EN ISO 21258:2010 Stationary source emissions - Determination of the mass concentration of dinitrogen monoxide (N2O) - Reference method: Non-dispersive infrared method (ISO 21258:2010)

Group Standards of the People's Republic of China, Reference method for in vitro diagnostics

T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents

Association Francaise de Normalisation, Reference method for in vitro diagnostics

NF EN ISO 16256:2021 Laboratoires d'analyses de biologie médicale et systèmes de diagnostic in vitro - Méthode de référence de microdilution en milieu liquide pour soumettre à essai l'activité in vitro des agents antimicrobiens par rapport aux levures impliquées ...
NF S92-012*NF EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
NF EN ISO 15193:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence
NF S92-035*NF EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
NF EN ISO 15194:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les échantillons d'origine biologique - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée
XP CEN/TS 17405:2020 Emissions de sources fixes - Détermination de la concentration volumique en dioxyde de carbone - Méthode de référence : spectrométrie infrarouge
NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
NF S92-012*NF EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
NF S92-053-1*NF EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1 : reference method for testing the in vitro activity of anti
NF EN ISO 283:2023 Courroies transporteuses à carcasse textile - Résistance à la traction, allongement à la rupture et allongement sous force de référence en pleine épaisseur - Méthode d'essai
NF EN ISO 20776-1:2020 Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 1 : méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobie...
NF X43-370*NF EN 14789:2017 Stationary source emissions - Determination of volume concentration of oxygen - Standard reference method : Paramagnetism
NF S92-020*NF EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
NF S92-019*NF EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
NF EN ISO 18134-1:2022 Biocombustibles solides - Dosage de la teneur en humidité - Méthode de séchage à l'étuve - Partie 1 : Méthode de référence
XP CEN ISO/TS 5798:2023 Systèmes d'essai pour diagnostic in vitro - Exigences et recommandations pour la détection du coronavirus 2 associé au syndrome respiratoire aigu sévère (SARS-CoV-2) par des méthodes d'amplification des acides nucléiques
NF X43-374*NF EN 15058:2017 Stationary source emissions - Determination of the mass concentration of carbon monoxide - Standard reference method : non-dispersive infrared spectrometry
NF EN ISO 21258:2010 Émissions de sources fixes - Détermination de la concentration massique de protoxyde d'azote (N2O) - Méthode de référence : méthode infrarouge non dispersive
NF EN 15058:2017 Émissions de sources fixes - Détermination de la concentration massique de monoxyde de carbone - Méthode de référence normalisée : spectrométrie infrarouge non dispersive
NF T47-102*NF EN ISO 283:2016 Textile conveyor belts - Full thickness tensile strength, elongation at break and elongation at the reference load - Test method
NF P18-310-13*NF EN 480-13:2015 Admixtures for concrete, mortar and grout - Test methods - Part 13 : reference masonry mortar for testing mortar admixtures
FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
NF X34-106-1*NF EN ISO 18134-1:2016 Solid biofuels - Determination of moisture content - Oven dry method - Part 1 : total moisture - Reference method

ES-UNE, Reference method for in vitro diagnostics

UNE-EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021) (Endorsed by Asociac...

未注明发布机构, Reference method for in vitro diagnostics

DIN EN ISO 16256:2022 Laboratory medical examinations and in vitro diagnostic systems – Broth microdilution reference method for testing the in vitro activity of antimicrobial substances against budding fungi that cause infectious diseases
BS EN ISO 15193:2009(2016) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
BS EN 480-15:2023 Admixtures for concrete, mortar and grout — Test methods Part 15 : Reference concrete and method for testing viscosity modifying admixtures
DIN EN ISO 20776-2:2022 Laboratory medical examinations and in vitro diagnostic systems – Susceptibility testing of infectious agents and evaluation of devices for antimicrobial susceptibility testing – Part 2: Evaluation of the performance of test systems for antimicrobial susc

German Institute for Standardization, Reference method for in vitro diagnostics

DIN EN ISO 16256:2022-02 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021); German version EN I...
DIN EN ISO 15193:2009-10 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009
DIN EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO/DIS 16256:2021); German and English
DIN EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
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 EN ISO 15194:2009-10 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009
DIN 58988:2010-03 Haemostaseology - Reference method for the VWF multimeres; Text in German and English
DIN CEN/TS 17405:2020-11 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry; German version CEN/TS 17405:2020
DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN 58988:2023 Haemostaseology - Reference method for the Von Willebrand Factor multimers; Text in German and English
DIN EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10
DIN 10348:1988-10 Determination of the total solids content of milk and cream; reference method
DIN EN 480-1:2021 Admixtures for concrete, mortar and grout - Test methods - Part 1: Reference concrete and reference mortar for testing; German and English version prEN 480-1:2021
DIN CEN/TS 17405:2020 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry; German version CEN/TS 17405:2020
DIN EN ISO 5534:2004-09 Cheese and processed cheese - Determination of the total solids content (Reference method) (ISO 5534:2004); German version EN ISO 5534:2004
DIN EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); English version of DIN EN ISO 15194:2009-10
DIN 58988:2023-04 Haemostaseology - Reference method for the Von Willebrand Factor multimers; Text in German and English / Note: Date of issue 2023-03-03*Intended as replacement for DIN 58988 (2010-03).
DIN EN ISO 18134-1:2023-01 Solid biofuels - Determination of moisture content - Part 1: Reference method (ISO 18134-1:2022); German version EN ISO 18134-1:2022
DIN EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012); German version EN ISO 16256:2012
DIN EN 480-15:2021 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures; German and English version prEN 480-15:2021
DIN EN 480-15:2021-12 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures; German and English version prEN 480-15:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN E...
DIN EN 480-15:2013-06 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures; German version EN 480-15:2013 / Note: To be replaced by DIN EN 480-15 (2021-12).
DIN EN 14789:2017-05 Stationary source emissions - Determination of volume concentration of oxygen - Standard reference method: Paramagnetism; German version EN 14789:2017
DIN CEN ISO/TS 5798:2023-03 In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022); German version CEN ISO/TS 5798:2022
DIN EN 15058:2017-05 Stationary source emissions - Determination of the mass concentration of carbon monoxide - Standard reference method: non-dispersive infrared spectrometry; German version EN 15058:2017
DIN EN ISO 18134-1:2023 Solid biofuels - Determination of moisture content - Part 1: Reference method (ISO 18134-1:2022)
DIN EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN EN ISO 21258:2010-11 Stationary source emissions - Determination of the mass concentration of dinitrogen monoxide (N<(Index)2>O) - Reference method: Non-dispersive infrared method (ISO 21258:2010); German version EN ISO 21258:2010
DIN EN ISO 3727-2:2002-04 Butter - Determination of moisture, non-fat solids and fat contents - Part 2: Determination of non-fat solids content (Reference method) (ISO 3727-2:2001); German version EN ISO 3727-2:2001

国家市场监督管理总局、中国国家标准化管理委员会, Reference method for in vitro diagnostics

GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation

International Organization for Standardization (ISO), Reference method for in vitro diagnostics

ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
ISO 15193:2002 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
ISO 20776-1:2019 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Refe
ISO 13366-1:2008 Milk - Enumeration of somatic cells - Part 1: Microscopic method (Reference method)
ISO 13366-1:2008|IDF 148-1:2008 Colony counting of somatic cells in milk Part 1: Microscopy (reference method)
ISO 15704:2019 Enterprise modelling and architecture — Requirements for enterprise-referencing architectures and methodologies
ISO 15704:2000 Industrial automation systems - Requirements for enterprise-reference architectures and methodologies
ISO 20166-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
ISO 13366-1:2008/cor 1:2009 Milk — Enumeration of somatic cells — Part 1: Microscopic method (Reference method) TECHNICAL CORRIGENDUM 1
ISO 15704:2000/Amd 1:2005 Industrial automation systems - Requirements for enterprise-reference architectures and methodologies - Amendment 1: Additional views for user concerns

GOSTR, Reference method for in vitro diagnostics

GOST R ISO 20776-1-2010 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 1. Reference method for testing the in vitro activity of antimic

AT-ON, Reference method for in vitro diagnostics

OENORM EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO/DIS 16256:2021)
ONR CEN/TS 17405-2020 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry (CEN/TS 17405:2020)
ONORM DIN 10348-1992 Determination of total solids content of milk and cream - Reference method

YU-JUS, Reference method for in vitro diagnostics

JUS N.R1.470-1985 Semiconductor devices. Reference methods of measurement

American Society for Testing and Materials (ASTM), Reference method for in vitro diagnostics

ASTM E908-98(2012) Standard Practice for Calibrating Gaseous Reference Leaks
ASTM E1921-18 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-18a Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-19a Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-22 Standard Test Method for Determination of Reference Temperature, T0, for Ferritic Steels in the Transition Range
ASTM E1921-19 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-19b Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-20 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-17 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-21a Standard Test Method for Determination of Reference Temperature, T0, for Ferritic Steels in the Transition Range
ASTM E1921-09c Standard Test Method for Determination of Reference Temperature, T_o, for Ferritic Steels in the Transition Range
ASTM E1921-09a Standard Test Method for Determination of Reference Temperature, T_o, for Ferritic Steels in the Transition Range
ASTM E1921-19be1 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-17a Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM D7330-11 Standard Test Method for Assessment of Surface Appearance Change in Pile Floor Coverings Using Standard Reference Scales
ASTM E1921-12 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-13 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-15 Standard Test Method for Determination of Reference Temperature, To, for Ferritic Steels in the Transition Range
ASTM E1921-11a Standard Test Method for Determination of Reference Temperature, T_o, for Ferritic Steels in the Transition Range
ASTM D7330-15 Standard Test Method for Assessment of Surface Appearance Change in Pile Floor Coverings Using Standard Reference Scales
ASTM D7330-22 Standard Test Method for Assessment of Surface Appearance Change in Pile Floor Coverings Using Standard Reference Scales
ASTM E1921-23 Standard Test Method for Determination of Reference Temperature, T0, for Ferritic Steels in the Transition Range

IT-UNI, Reference method for in vitro diagnostics

UNI CEN/TS 17405-2020 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry

Lithuanian Standards Office , Reference method for in vitro diagnostics

LST CEN/TS 17405-2020 Stationary source emissions - Determination of the volume concentration of carbon dioxide - Reference method: infrared spectrometry
LST ISO 13580:2005 Yogurt. Determination of total solids content (Reference method) (idt ISO 13580:2005)
LST EN 480-1-2006+A1-2011 Admixtures for concrete, mortar and grout - Test methods - Part 1: Reference concrete and reference mortar for testing
LST ISO 6734:2011 Sweetened condensed milk - Determination of total solids content (Reference method) (ISO 6734:2010, identical)
LST EN ISO 13366-1:2008 Milk - Enumeration of somatic cells - Part 1: Microscopic method (Reference method) (ISO 13366-1:2008)
LST EN 14789-2006 Stationary source emissions - Determination of volume concentration of oxygen (O2) - Reference method - Paramagnetism
LST EN ISO 5534:2004 Cheese and processed cheese - Determination of the total solids content (Reference method) (ISO 5534:2004)
LST ISO 3728:2004 Ice-cream and milk ice - Determination of total solids content (Reference method) (idt ISO 3728:2004)
LST EN 15058-2006 Stationary source emissions - Determination of the mass concentration of carbon monoxide (CO) - Reference method: Non-dispersive infrared spectrometry
LST ISO 6731:2011 Milk, cream and evaporated milk - Determination of total solids content (Reference method) (ISO 6731:2010, identical)
LST EN ISO 21258:2010 Stationary source emissions - Determination of the mass concentration of dinitrogen monoxide (N2O) - Reference method: Non-dispersive infrared method (ISO 21258:2010)
LST EN 480-13-2009+A1-2011 Admixtures for concrete, mortar and grout - Test methods - Part 13: Reference masonry mortar for testing mortar admixtures
LST EN 14774-1-2010 Solid biofuels - Determination of moisture content - Oven dry method - Part 1: Total moisture - Reference method
LST EN ISO 283:2007 Textile conveyor belts - Full thickness tensile strength, elongation at break and elongation at the reference load - Test method (ISO 283:2007)

Professional Standard - Automobile, Reference method for in vitro diagnostics

QC/T 567-1999 The method of measuring the reference volume of the trunk of a car

Japanese Industrial Standards Committee (JISC), Reference method for in vitro diagnostics

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
JIS K 6377-7:2022 Conveyor belts -- Full thickness tensile strength, elongation at break and elongation at the reference load -- Test method
JIS R 1693-1:2012 Measurement method for emissivity of fine ceramics and ceramic matrix composites -- Part 1: Normal spectral emissivity by black body reference method using FTIR

Professional Standard - Medicine, Reference method for in vitro diagnostics

YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic test systems -Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices -Part 1: Reference method for testing the in vitro activity of antimicrobia

International Dairy Federation (IDF), Reference method for in vitro diagnostics

IDF 148-1-2008 Milk - Enumeration of somatic cells - Part 1: Microscopic method (Reference method)
IDF 4-2004 Cheese and processed cheese - Determination of the total solids content (Reference method)

IX-EU/EC, Reference method for in vitro diagnostics

2011/C 242/02-2011 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
2011/C 307/03-2011 Commission communication in the framework of the implementation of Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys
MEDDEV 2.14/3-2007 GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
2011/C 16/03-2011 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
2011/C 185/03-2011 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
2011/C 242/03-2011 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
2012/C 262/03-2012 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Text with EEA relevance; Publication of titles and reference
2013/C 22/03-2013 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Text with EEA relevance; Publication of titles and reference
2015/C 014/06-2015 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards
2015/C 226/03-2015 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards
2007/C186/05-2007 Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
MEDDEV 2.14/1-2004 GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES Rev. 1
M 252-1997 Standardization mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices

IN-BIS, Reference method for in vitro diagnostics

International Telecommunication Union (ITU), Reference method for in vitro diagnostics

ITU-T G.1011-2015 Reference guide to quality of experience assessment methodologies (Study Group 12)
ITU-T G.1011-2013 Reference guide to quality of experience assessment methodologies Study Group 12

ITU-T - International Telecommunication Union/ITU Telcommunication Sector, Reference method for in vitro diagnostics

ITU-T G.1011-2010 Reference guide to quality of experience assessment methodologies (Study Group 12)

Danish Standards Foundation, Reference method for in vitro diagnostics

DS/EN 480-1+A1:2011 Admixtures for concrete, mortar and grout - Test methods - Part 1: Reference concrete and reference mortar for testing
DS/EN ISO 5534:2004 Cheese and processed cheese products - Determination of the total solids content (Reference method)
DS/EN 14789:2005 Stationary source emissions - Determination of volume concentration of oxygen (O2) - Reference method - Paramagnetism
DS/EN 480-15:2013 Admixtures for concrete, mortar and grout - Test methods - Part 15: Reference concrete and method for testing viscosity modifying admixtures
DS/EN ISO 21258:2010 Stationary source emissions - Determination of the mass concentration of dinitrogen monoxide (N2O) - Reference method: Non-dispersive infrared method
DS/EN 15058:2006 Stationary source emissions – Determination of the mass concentration of carbon monoxide (CO) – Reference method: Non-dispersive infrared spectrometry
DS/EN ISO 283:2007 Textile conveyor belts - Full thickness tensile strength, elongation at break and elongation at the reference load - Test method
DS/EN 480-13+A1:2011 Admixtures for concrete, mortar and grout - Test methods - Part 13: Reference masonry mortar for testing mortar admixtures
DS/EN 14774-1:2010 Solid biofuels - Determination of moisture content - Oven dry method - Part 1: Total moisture - Reference method

EU/EC - European Union/Commission Legislative Documents, Reference method for in vitro diagnostics

2016/C 249/05 CORR-2016 Corrigendum to Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under U
2012/C 123/03-2012 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Text with EEA relevance; Publication of titles and reference
2010/C 183/04-2010 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ((Text with EEA relevance) (Publication of titles and referen
2016/C 173/04-2016 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (Text with EEA relevance; Publication of titles and references of harmonised sta
COM(2012) 541 FINAL-2012 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (2012/0267 (COD); Text with EEA relevance; SWD(2012) 273; SWD(2012) 274)

RO-ASRO, Reference method for in vitro diagnostics

STAS SR ISO 6731:1996 Milk, cream and evaporated milk - Determination of total solids content (Reference method)

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Reference method for in vitro diagnostics

ASHRAE CH-99-5-2-1999 Automated Fault Detection and Diagnostics for Outdoor-Air Ventilation Systems and Economizers: Methodology and Results from Field Testing

Standard Association of Australia （SAA）, Reference method for in vitro diagnostics

AS/NZS 3580.2.2:2016 Methods for sampling and analysis of ambient air, Method 2.2: Preparation of reference test atmospheres — Compressed gas method
AS/NZS 3580.2.2:2009

Professional Standard - Energy, Reference method for in vitro diagnostics

NB/T 20292-2014 Test method for determination of reference temperature, T<下标0>, for ferritic steels in the ductile-to-brittle transition range for nuclear power plants

Underwriters Laboratories (UL), Reference method for in vitro diagnostics

UL 489 CRD-2015 UL Standard for Safety Molded-Case Circuit Breakers, Molded-Case Switches and Circuit-Breaker Enclosures - Section / Paragraph Reference: 6.1.4.3.6 Subject: Revision to Field Wiring Conductor Length (Edition 12: January 15, 2013)

CU-NC, Reference method for in vitro diagnostics

NC 90-13-21-1984 Metrological Assurance. Spectrophotometers. Reference Dissolutions for the Verification of Spectrophotometers

American National Standards Institute （ANSI), Reference method for in vitro diagnostics

BS EN ISO 18134-1:2022 Tracked Changes. Solid biofuels. Determination of moisture content Reference method (British Standard)

SE-SIS, Reference method for in vitro diagnostics

SIS SS IEC 343:1982 Recommended test methods for determining the relative resistance of insulating materials to break-down by surface discharges