Analytical methods and validation of drugs

Analytical methods and validation of drugs, Total:260 items.

The international standard classification for "Analytical methods and validation of drugs" includes: .

The Chinese standard classification for "Analytical methods and validation of drugs" includes: Legal medical expert .

Professional Standard - Agriculture

289药典三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
317药典四部-2015 9000 Guiding Principles 9101 Guiding Principles for Validation of Analytical Methods for Pharmaceutical Quality Standards
328药典四部-2020 9000 Guidelines 9012 Guidelines for Validation of Quantitative Analysis Methods of Biological Samples
农业部630号公告-6-2006 Guiding principles for verification of analytical methods for quality standards of traditional Chinese medicines and natural medicines for veterinary use
2408药典二部-2010 Appendix XXIX A Guidelines for Validation of Analytical Methods for Drug Quality Standards
361药典三部-2020 Guideline 9101 Guidelines for Validation of Analytical Methods
362药典三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
2421药典二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
878兽药典一部-2015 Appendix Contents 9000 Guidelines 9101 Guidelines for Validation of Analytical Methods for Quality Standards of Veterinary Drugs
330药典三部-2015 Technical Guide 9101 General Principles of Validation Guidelines for Analytical Methods of Pharmaceutical Quality Standards 213
1837药典一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products
1833药典一部-2010 Appendix XVIII A Guidelines for Validation of Analytical Methods for Quality Standards of Traditional Chinese Medicine
313药典四部-2015 9000 Guidelines 9012 Guidelines for Validation of Quantitative Analysis Methods of Biological Samples
SN/T 5326.4-2023 Guideline on validation of test methods for food and cosmetics of import and export - Part 4 : Molecular biological method
农业部630号公告-11-2006 Technical guidelines for validation of analytical methods for quality control of veterinary chemicals

司法部

SF/T 0063-2020 General rules for method validation in forensic toxicology

Group Standards of the People's Republic of China

T/CECPA 002-2020 Evaluation and Validation Method for Nuclear Power Design and Safety Analysis Software
T/CAQI 107-2020 General Rule for Verificaiton and Evaluation of Analytical Instrument
T/CCAS 006-2018 Validation and comprehensive evaluation specification of laser particle size analyzer (wet method)

未注明发布机构

DIN CEN/TS 16800:2016*DIN SPEC 38402-61:2016 Guideline for the validation of physico-chemical analytical methods
DIN 10741 E:2009-03 Analysis of honey - General guidelines for the ad hoc validation of analysis methods for organic residues or contaminants
DIN CEN/TS 17174:2018*DIN SPEC 10796:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
DIN EN ISO 16140-5 E:2018-02 Validation of methods in food chain microbiology Part 5: Factorial interlaboratory validation protocol for non-proprietary methods (draft)
DIN EN ISO 16140-4 E:2018-02 Validation of methods in food chain microbiology Part 4: Protocol for method validation in individual laboratories (draft)

农业农村部

NY/T 3151-2017 Guideline on the development and validation of analytical methods for pesticides in the soil and water

Military Standard of the People's Republic of China-General Armament Department

GJB 770.102-1989 Test methods for gunpowder analysis - Determination of moisture content in double base powder - Drying method
GJB 770.202-1993 Test methods for gunpowder analysis - Weighing method for determination of carbon black content in double base powder
GJB 770.103-1990 Gunpowder Analysis Test Method Double Base Powder Extraction
GJB 770.107-1991 Test methods for gunpowder analysis Determination of moisture content in propellant powder Distillation method
GJB 770.203-1993 Test methods for gunpowder analysis - Determination of carbon black content in double base powder - Spectrophotometric method
GJB 770.106-1991 Test methods for gunpowder analysis - Determination of moisture content in double base powder - Acetylene method
GJB 770.105-1991 Test methods for gunpowder analysis - Determination of moisture content in double base powder - Oven method
GJB 770.101-1989 Gunpowder Analysis Test Method Double Base Powder Sample Preparation

Jilin Provincial Standard of the People's Republic of China

DB22/T 2516-2016 Validation specification for a new method for the detection of drug residues in aquatic products

国家市场监督管理总局

RB/T 033-2020 Guidance on verification and validation of microbiological testing methods

Taiwan Provincial Standard of the People's Republic of China

CNS 14683-2002 Method of test for veterinary drug residues in food－Hormone mulit-residue analysis

Shanxi Provincial Standard of the People's Republic of China

DB1404/T 18-2021 Inspection and testing laboratory instrument analysis method validation requirements Spectroscopy
DB14/T 2798-2023 Specification for verification of chemical analysis methods in testing laboratories
DB1404/T 17-2021 Inspection and testing laboratory instrument analytical method validation requirements chromatography

Professional Standard - Certification and Accreditation

RB/T 190-2015 Procedure for validation of chemical analysis methods for chemicals, minerals and metallic materials

Military Standard of the People's Republic of China-Commission of Science,Technology and Industry for National Defence

GJB 5382.13-2005 Test methods of physical parameter for pyrotechnic. Part 13: Determination of coefficient of linear expansion TMA method

ES-UNE

UNE-CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods (Endorsed by Asociación Española de Normalización in February of 2021.)
UNE-CEN ISO/TR 24094:2012 IN Analysis of natural gas - Validation methods for gaseous reference materials (ISO/TR 24094:2006)
UNE-CEN/TS 17455:2021 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
UNE-EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
UNE-EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
UNE-EN ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)

British Standards Institution (BSI)

BS PD CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
BS PD CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
BS ISO 12828-2:2016 Validation methods for fire gas analyses. Intralaboratory validation of quantification methods
PD CEN ISO/TR 24094:2007 Analysis of natural gas. Validation methods for gaseous reference materials
BS PD CEN ISO/TR 24094:2007 Analysis of natural gas — Validation methods for gaseous reference materials
BS PD CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
PD CEN/TS 17455:2020 Animal feeding stuffs. Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
PD ISO/TS 22176:2020 Cosmetics. Analytical methods. Development of a global approach for validation of quantitative analytical methods
BS ISO 11726:2017 Solid mineral fuels. Guidelines for the validation of alternative methods of analysis
PD ISO/TS 16393:2019 Molecular biomarker analysis. Determination of the performance characteristics of qualitative measurement methods and validation of methods
BS 1016-6:1977 Methods for analysis and testing of coal and coke - Ultimate analysis of coal
BS ISO 11726:2005 Solid mineral fuels - Guidelines for the validation of alternative methods of analysis
BS ISO 24190:2023 Biotechnology. Analytical methods. Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
BS 1016-14:1963 Methods for analysis and testing of coal and coke - Analysis of coal ash and coke ash
21/30423811 DC BS EN 13631-10. Explosives for civil uses. Explosives - Part 10. Method for the verification of the means of initiation of explosives
BS 1016-7:1977 Methods for analysis and testing of coal and coke - Ultimate analysis of coke
BS EN ISO 16140-2:2016 Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods against a reference method
22/30397817 DC BS ISO 24190. Biotechnology. Analytical Methods. Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses
BS 3762-3.25:1989 Analysis of formulated detergents - Quantitative test methods - Methods for determination of water and volatile matter content
BS ISO 7210:2013 Routine analytical cigarette-smoking machine. Additional test methods for machine verification
BS ISO 12787:2011 Cosmetics. Analytical methods. Validation criteria for analytical results using chromatographic techniques
BS EN ISO 16140-3:2021 Microbiology of the food chain. Method validation. Protocol for the verification of reference methods and validated alternative methods in a single laboratory
23/30452546 DC BS EN ISO 16140-7. Microbiology of the food chain. Method validation - Part 7. Protocol for the validation of identification methods of microorganisms
BS EN ISO 16140-4:2020 Microbiology of the food chain. Method validation - Protocol for method validation in a single laboratory
BS EN ISO 16140-5:2020 Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods
BS EN ISO 16140-6:2019 Microbiology of the food chain. Method validation - Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

Lithuanian Standards Office

LST CEN/TS 16800-2021 Guideline for the validation of physico-chemical analytical methods
LST EN 13631-10-2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
LST EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

Association Francaise de Normalisation

XP T90-800*XP CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
NF EN ISO 16140-2:2016 Microbiology of the food chain - Validation of methods - Part 2: protocol for the validation of alternative (commercial) methods compared to a reference method
XP V18-800*XP CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
XP V18-801*XP CEN/TS 17455:2020 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
NF ISO 12828-2:2020 Validation method for fire gas analyzes - Part 2: intralaboratory validation of quantification methods
NF X65-040-2*NF ISO 12828-2:2020 Validation method for fire gas analysis - Part 2 : Intralaboratory validation of quantification methods
XP ISO/TS 16393:2019 Analysis of molecular biomarkers - Determination of performance characteristics of qualitative measurement methods and method validation
XP ISO/TS 22176:2020 Cosmetics - Analytical methods - Development of a global approach for the validation of quantitative analytical methods
XP CEN/TS 16800:2021 Guidelines for the validation of physicochemical analytical methods
NF EN ISO 16140-5:2020 Microbiology of the food chain - Validation of methods - Part 5: protocol for interlaboratory validation of non-commercial methods by factorial design
NF U47-400:2014 Animal health analysis methods - Guide for the organisation of interlaboratory proficiency testing in animal health
XP X65-040-3*XP ISO/TS 12828-3:2020 Validation method for fire gas analysis - Part 3 : considerations related to interlaboratory trials
XP CEN/TS 17455:2020 Animal feed - Sampling and analysis methods - Performance criteria for mycotoxin analysis methods validated in a single laboratory or following an interlaboratory test
XP CEN/TS 17174:2018 Animal feed: Sampling and analysis methods - Performance criteria for analysis methods validated by one or more laboratories for the determination of heavy metals
XP X31-131:2020 Test methods for the environmental characterization of solid matrices - Characterization of analytical methods - Guide for the validation of physico-chemical analytical methods in soil, sediment and sludge matrices and for the selection of test samples
NF EN ISO 16140-3:2021 Microbiology of the food chain - Validation of methods - Part 3: protocol for the verification in a single laboratory of validated reference methods and alternative methods
NF EN ISO 20072:2013 Verification of the design of an aerosol drug delivery device - Requirements and test methods
NF EN ISO 6143:2006 Gas analysis - Comparative methods for determining and verifying the composition of gas mixtures for calibration
FD A06-500*FD CEN/TR 10350:2013 Analysis of steels and irons - Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
NF V08-103-5*NF EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: protocol for method validation in a single laboratory
NF V37-022:2013 Routine analytical cigarette-smoking machine - Additional test methods for machine verification
NF V08-103-4*NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
FD CEN/TR 16059:2011 Analysis of food products - Performance criteria for validated single-laboratory mycotoxin analysis methods
NF V08-103-2*NF EN ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2 : protocol for the validation of alternative (proprietary) methods against a reference method
NF V08-103-3*NF EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3 : protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
NF ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
FD A06-002*FD CEN/TR 10345:2014 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
FD CEN/TR 17063:2017 Foods of plant origin - Multimethod for determining pesticide residues by GC or CL analysis after extraction/partition with acetonitrile and purification by dispersive SPE - Validation data of the modular method ...

SCC

DIN CEN/TS 16800:2024 Guideline for the validation of physico-chemical analytical methods; German version CEN/TS 16800:2020
DANSK DS/CEN ISO/TR 24094:2008 Analysis of natural gas - Validation methods for gaseous reference materials
AWWA WQTC71481 Statistical Consideration for Validating a New Microbial Analysis Method
DANSK DS/ISO 12828-2:2016 Validation methods for fire gas analyses -- Part 2: Intralaboratory validation of quantification methods
DANSK DS/CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis – Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
BS PD CEN/TS 17455:2020 Animal feeding stuffs. Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
BS PD ISO/TS 22176:2020 Cosmetics. Analytical methods. Development of a global approach for validation of quantitative analytical methods
SN-CEN/TS 17455:2020 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
BS ISO 11726:2004 Solid mineral fuels. Guidelines for the validation of alternative methods of analysis
DANSK DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
DANSK DS/ISO/TS 16393:2019 Molecular biomarker analysis – Determination of the performance characteristics of qualitative measurement methods and validation of methods
BS PD ISO/TS 16393:2019 Molecular biomarker analysis. Determination of the performance characteristics of qualitative measurement methods and validation of methods
DIN CEN/TS 16800 E:2014 Draft Document - Guideline for the validation of analytical methods; German version FprCEN/TS 16800:2014
SN-CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
SN-CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
DIN 10741 E:2009 Draft Document - Analysis of honey - General guidelines for the ad hoc validation of analysis methods for organic residues or contaminants
DANSK DS/ISO/TS 12828-3:2020 Validation method for fire gas analysis – Part 3: Considerations related to interlaboratory trials
AENOR UNE-CEN ISO/TR 24094 IN:2012 Analysis of natural gas - Validation methods for gaseous reference materials (ISO/TR 24094:2006)
SN-CEN ISO/TR 24094:2007 Analysis of natural gas — Validation methods for gaseous reference materials (ISO/TR 24094:2006)
DANSK DS/ISO 24190:2023 Biotechnology – Analytical methods – Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
DANSK DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
NS-EN 13631-10:2003 Explosives for civil uses — High explosives — Part 10: Method for the verification of the means of initiation
AENOR UNE 77241:2001 Gas analysis. Verification of calibration gas mixtures by a comparison method.
BS 1016-17:1979 Methods for analysis and testing of coal and coke-Size analysis of coal
BS 1016-18:1981 Methods for analysis and testing of coal and coke-Size analysis of coke
DANSK DS/ISO 16140-3:2021 Microbiology of the food chain â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
DANSK DS/ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory
DANSK DS/CEN/TR 10350:2013 Analysis of steels and irons - Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
DANSK DS/ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
BS PD CEN/TR 10350:2013 Analysis of steels and irons. Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
DANSK DS/EN ISO 16140-3:2021 Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
NS-EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
DANSK DS/CEN/TR 16059:2011 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
10/30201045 DC BS ISO 12787. Cosmetics. Analytical methods. Validation criteria for analytical results using chromatographic techniques
SN-CEN/TR 16059:2010 Food analysis — Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins

European Committee for Standardization (CEN)

PD CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
PD CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
CEN ISO/TR 24094:2007 Analysis of natural gas - Validation methods for gaseous reference materials
EN ISO/TR 24094:2007 Analysis of natural gas - Validation methods for gaseous reference materials
PD CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
prEN 13631-10-2021 Explosives for civil uses - Explosives - Part 10: Method for the verification of the means of initiation of explosives
CEN/TR 10350:2013 Analysis of steels and irons - Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
EN ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)
prEN ISO 11781 Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)
EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
CEN/TR 16059:2010 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
CEN/TR 10345:2013 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

Danish Standards Foundation

DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
DS/CEN ISO/TR 24094:2008 Analysis of natural gas - Validation methods for gaseous reference materials
DS/ISO 16140-3:2021 Microbiology of the food chain â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
DS/CEN/TR 10350:2013 Analysis of steels and irons - Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
DS/ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
DS/EN ISO 16140-3:2021 Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
DS/CEN/TR 16059:2011 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
DS/CEN/TR 10345:2008 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

IT-UNI

UNI CEN/TS 16800-2021 Guideline for the validation of physico-chemical analytical methods

KR-KS

KS I ISO TR 24094-2023 Analysis of natural gas — Validation methods for gaseous reference materials
KS E ISO 11726-2018 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS P ISO 20072-2021 Aerosol drug delivery device design verification —Requirements and test methods

WRC - Welding Research Council

BULLETIN 308-1985 VERIFICATION AND APPLICATION OF AN INELASTIC ANALYSIS METHOD FOR LMFBR PIPING SYSTEM

American Welding Society (AWS)

WRC 308:1985 Verification and Application of an Inelastic Analysis Method for LMFBR Piping System

GSO

GSO ISO/TR 24094:2013 Analysis of natural gas -- Validation methods for gaseous reference materials
BH GSO ISO 22176:2023 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
GSO ISO 22176:2022 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
BH GSO ISO 12828-2:2022 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
GSO ISO 12828-2:2021 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
OS GSO ISO 12787:2013 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques
BH GSO ISO 12787:2016 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques
GSO ISO 6143:2013 Gas analysis -- Comparison methods for determining and checking the composition of calibration gas mixtures
GSO ISO 16140-2:2021 Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
BH GSO ISO 16140-2:2022 Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
GSO ISO 12787:2013 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques

American Society for Testing and Materials (ASTM)

ASTM E2882-19 Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
ASTM E2857-11(2016) Standard Guide for Validating Analytical Methods
ASTM E2857-21 Standard Guide for Validating Analytical Methods
ASTM E2857-11(2021)e1 Standard Guide for Validating Analytical Methods
ASTM E2857-11 Standard Guide for Validating Analytical Methods
ASTM E2857-22 Standard Guide for Validating Analytical Methods
ASTM E2918-23 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2918-18 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2918-13 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2918-18a Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2402-19 Standard Test Method for Mass Loss and Residue Measurement Validation of Thermogravimetric Analyzers
ASTM E2402-11(2017) Standard Test Method for Mass Loss and Residue Measurement Validation of Thermogravimetric Analyzers
ASTM E2402-24 Standard Test Method for Mass Loss, Residue, and Temperature Measurement Validation of Thermogravimetric Analyzers
ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E2549-09 Standard Practice for Validation of Seized-Drug Analytical Methods
ASTM E2898-20 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E2161-07 Standard Terminology Relating to Performance Validation in Thermal Analysis

Compressed Gas Association (U.S.)

CGA M-6-2013 Guideline for analytical method volidation

Korean Agency for Technology and Standards (KATS)

KS I ISO 24094-2010(2021) Analysis of natural gas－Validation methods for gaseous reference materials
KS I ISO 24094-2010(2016) Analysis of natural gas－Validation methods for gaseous reference materials
KS E ISO 11726-2023 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS E ISO 11726:2018 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS M 4801-2006(2021) Analytical methods of explosives
KS M 4801-2006(2016) Analytical methods of explosives
KS E ISO 11726:2007 Solid mineral fuels－Guidelines for the validation of alternative methods of analysis
KS I ISO 24094:2010 Analysis of natural gas－Validation methods for gaseous reference materials
KS M 4801-2021 Analytical methods of explosives
KS P ISO 20072:2021 Aerosol drug delivery device design verification —Requirements and test methods
KS M ISO 12787-2014(2019) Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
KS M ISO 12787-2019 Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
KS M ISO 12787:2014 Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques

German Institute for Standardization

DIN CEN/TS 17174:2018-10*DIN SPEC 10796:2018-10 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals; German version CEN/TS 17174:2018
DIN CEN/TS 17455:2020-07 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins; German version CEN/TS 17455:2020
DIN 10741:2010-08 Analysis of honey - General guidelines for the ad hoc validation of analysis methods for organic residues or contaminants
DIN 10741:2010 Analysis of honey - General guidelines for the ad hoc validation of analysis methods for organic residues or contaminants
DIN EN 13631-10:2004-02 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation; German version EN 13631-10:2003 / Note: To be replaced by DIN EN 13631-10 (2021-05).
DIN EN ISO 16140-3:2021-06 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021); German version EN ISO 16140-3:2021
DIN EN ISO 16140-4:2020-12 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020); German version EN ISO 16140-4:2020
DIN EN ISO 16140-2:2016-11 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016); German version EN ISO 16140-2:2016
DIN EN ISO 11781:2024-01 Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023); German and English version prEN ISO 11781:2023 / Note: Date of issue 2023-11-24*Intended as replacement for DI...
DIN CEN/TS 16800:2016-03*DIN SPEC 38402-61:2016-03 Guideline for the validation of physico-chemical analytical methods (CEN/TS 16800:2015); German version CEN/TS 16800:2015
DIN ISO 7210:2020-06 Routine analytical cigarette-smoking machine - Additional test methods for machine verification (ISO 7210:2018)
DIN CEN/TR 17063:2018-01*DIN SPEC 10489:2018-01 Foods of plant origin - Multimethod for the determination of pesticide residues using GC- or LC-based analysis following acetonitrile extraction/partitioning and cleanup by dispersive SPE - Validation data of the modular QuEChERS-method; German version...

International Organization for Standardization (ISO)

ISO/TS 12828-3:2020 Validation method for fire gas analysis — Part 3: Considerations related to interlaboratory trials
ISO 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
ISO/TS 16393:2019 Molecular biomarker analysis — Determination of the performance characteristics of qualitative measurement methods and validation of methods
ISO 12828-2:2016 Validation methods for fire gas analyses - Part 2: Intralaboratory validation of quantification methods
ISO/TS 22176:2020 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
ISO/CD TS 12828-3:2024 Validation method for fire gas analysis
ISO/DIS 11781:2023 Molecular biomarker analysis — General guidelines for single-laboratory validation of qualitative real-time PCR methods
ISO/FDIS 24190 Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
ISO 11726:2017 Solid mineral fuels - Guidelines for the validation of alternative methods of analysis
ISO 11726:2004 Solid mineral fuels - Guidelines for the validation of alternative methods of analysis
ISO/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
ISO/TR 24094:2006 Analysis of natural gas - Validation methods for gaseous reference materials
ISO 16140-4:2020/CD Amd 2 Microbiology of the food chain-Method validation-Part 4: Protocol for method validation in a single laboratory
ISO 16140-3:2021/CD Amd 1 Microbiology of the food chain-Method validation-Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
ISO 24190:2023 Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
ISO 7210:2013 Routine analytical cigarette-smoking machine - Additional test methods for machine verification
ISO 16140-4:2020/CD Amd 1 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 1: Annex H - Validation of larger test portion size for qualitative methods
ISO 16140-4:2020/DAmd 1 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 1: Validation of a larger test portion size for qualitative methods
ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory

Japanese Industrial Standards Committee (JISC)

JIS K 4809:1996 Analytical methods of explosives
JIS K 4833:2004 Analytical methods of slurry explosives and emulsion explosives

American Society of Mechanical Engineers (ASME)

ASME STP-PT-022-2008 COMPARISON AND VALIDATION OF CREEP-BUCKLING ANALYSIS METHODS

CZ-CSN

CSN 99 4179-1990 Grain testers. Methods of verification and calibrating

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

ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories

PL-PKN

PN-EN ISO 16140-3-2021-07 E Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

AENOR

UNE-EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation

GOST

GOST R 55291-2023 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis

Standard Association of Australia （SAA）

AS 16140.3:2022 Microbiology of the food chain — Method validation, Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021, MOD)

DIN

DIN EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

CH-SNV

SN EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

AT-ON

OENORM EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
OENORM EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

GB-REG

REG NASA-LLIS-6536-2012 Lessons Learned - Communicate Requirements Associated with Analysis Tied to Required Verification Data

Society of Automotive Engineers (SAE)

SAE J2869-2010 Mechanical Systems Physics-of-Failure Analysis Experimental Validation

ZA-SANS

SANS 5221:2007 Microbiological analysis of water - General test methods

Others: