Drug methodology validation

Drug methodology validation, Total:209 items.

The international standard classification for "Drug methodology validation" includes: Protection against crime , Pesticides and other agrochemicals .

The Chinese standard classification for "Drug methodology validation" includes: Social and public safety in general , Crime judging technology , Pesticide management and application method , Legal medical expert .

Professional Standard - Agriculture

农业部630号公告-11-2006 Technical guidelines for validation of analytical methods for quality control of veterinary chemicals
2421药典二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
343药典四部-2020 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
362药典三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
289药典三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
324药典四部-2015 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
农业部公告第2508号 List of inspection methods for 11 illegally added chemical drugs (substances) in veterinary drugs
882兽药典一部-2015 Appendix Contents 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Veterinary Drugs
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
1837药典一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products
331药典三部-2015 Technical Guideline 9201 General Guidelines for the Validation of Alternative Methods for Microbiological Testing of Drugs 216
农业部1247号公告-1-2009 Guiding principles for safety pharmacology tests of veterinary chemicals

Professional Standard - Public Safety Standards

GA/T 1423-2017 Analysis of plastics in forensics—Infrared spectrometry(IR)
GA/T 1936-2021 Forensic sciences-Examination methods for cross-section shapes of chemical fiber evidence-Microscopy
GA/T 823.1-2018 Examination methods for paint evidence in forensics―Part 1:Color comparison
GA/T 1424-2017 Methods for synthetic fiber examination in Forensics―Infrared spectrometry
GA/T 823.4-2018 Examination methods for paint evidence in Forensics―Part 4:Raman spectrometry
GA/T 1200-2014 Methods for examination of light distribution of evidence photography in forensic science
GA/T 1945-2021 Forensic sciences-Common inorganic explosives and their residues testing-Chemical method
GA/T 242-2018 Terminology for physical and chemical examination of trace evidence in Forensics
GA/T 1569-2019 Forensic sciences-Specifications for building laboratories for electronic evidence examination
GA/T 1568-2019 Forensic sciences-Terminology for electronic evidence examination

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

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

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

GB/T 15670.29-2017 Toxicological test methods for pesticides registration. Part 29: Metabolism and toxicokinetics study

国家技术监督局

GB/T 15670-1995 Toxicological test methods of pesticides for registration

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

GB 15670-1995 Toxicological test methods of pesticides for registration

Taiwan Provincial Standard of the People's Republic of China

CNS 8993-1982 Chemical Reagent(Determination of Colored Material of Sulfuric Acid)

司法部

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

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2798-2023 Specification for verification of chemical analysis methods in testing laboratories

British Standards Institution (BSI)

BS EN ISO 16140-4:2020+A1:2024 Microbiology of the food chain. Method validation - Protocol for method validation in a single laboratory
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
BS EN ISO 16140-2:2016+A1:2024 Microbiology of the food chain. Method validation - Protocol for the validation of alternative (proprietary) methods against a reference method
BS EN ISO 16140-5:2020 Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods
BS EN ISO 16140-4:2020 Microbiology of the food chain. Method validation - Protocol for method validation in a single laboratory
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
BS PD CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
BS PD CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
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 16140-1:2016 Microbiology of the food chain. Method validation. Vocabulary
ISO 16140-2:2016/Amd.1:2024 Microbiology of the food chain — Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
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
23/30445204 DC BS EN ISO 16140-4 AMD 1. Microbiology of the food chain. Method validation - Part 4. Protocol for method validation in a single laboratory
23/30444274 DC BS EN ISO 16140-2 AMD 1. Microbiology of the food chain. Method validation - Part 2. Protocol for the validation of alternative (proprietary) methods against a reference method
BS EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods
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 EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
BS EN ISO 20072:2010 Aerosol drug delivery device design verification. Requirements and test methods

International Organization for Standardization (ISO)

ISO/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
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 16140-4:2020 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
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 16140-3:2021 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 16140-4:2020/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 16140-4:2020/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 16140-2:2016/CD Amd 1 Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method — Amendment 1
ISO 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
ISO 16140-4:2020/Amd 1:2024 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 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
ISO 16140-6:2019 Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
ISO 20072:2009 Aerosol drug delivery device design verification - Requirements and test methods
ISO 16140:2003/Amd 1:2011 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods; Amendment 1

Spanish Association for Standardization (UNE)

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-CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods (Endorsed by Asociación Española de Normalización in February of 2021.)
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 16140-5:2021 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
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)
UNE-EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
UNE-EN ISO 16140-6:2020 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
UNE-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
UNE-EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation

Association Francaise de Normalisation

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 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
XP T90-800*XP CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
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 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 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
NF EN ISO 16140-1:2016 Microbiology of the food chain - Validation of methods - Part 1: vocabulary
NF EN ISO 16140-6:2019 Microbiology of the food chain - Validation of methods - Part 6: protocol for the validation of alternative (commercial) methods for microbiological confirmation and typing
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 EN ISO 20072:2013 Verification of the design of an aerosol drug delivery device - Requirements and test 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 V08-103-1*NF EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1 : vocabulary
NF X45-307:2000 Filter cartridges - Test methods - Verification of chemical resistance of filter elements.
NF S93-100*NF EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods

German Institute for Standardization

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 E:2013-01 Validation of methods in food chain microbiology Part 2: Validation of alternatives against reference methods (draft)
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 16140-5:2020-12 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020); German version EN ISO 16140-5:2020
DIN EN ISO 16140-7:2023-05 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023); German and English version prEN ISO 16140-7:2023 / Note: Date of issue 2023-04-21
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)
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 16140-1:2016-11 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016); German version EN ISO 16140-1:2016
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 16140-2:2016 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)
DIN EN ISO 16140-6:2020-04 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019); German version EN ISO 16140-6:2019
DIN EN ISO 16140-2/A1:2023 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - AMENDMENT 1: Revision of qualitative MCS data evaluation, RLOD calculations in the ILS, calculati...
DIN EN ISO 16140-3:2018 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference and validated alternative methods implemented in a single laboratory (ISO/DIS 16140-3:2017); German and English version prEN ISO 16140-3:2017
DIN EN ISO 16140-4/A1:2023 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 16140-4:2020/DAM 1:2023); German and English version...
DIN EN ISO 16140-4/A1:2023-08 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 16140-4:2020/DAM 1:2023); German and English version...
DIN EN ISO 16140-6:2020 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
DIN EN ISO 16140-4:2020 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 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 16140-1 E:2013-01 Validation of microbiological methods in the food chain Part 1: Glossary (draft)
DIN EN ISO 16140-7:2023 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023); German and English version prEN ISO 16140-7:2023
DIN 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); German version EN ISO 16140-5:2020

SCC

DANSK DS/ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory
DIN CEN/TS 16800:2024 Guideline for the validation of physico-chemical analytical methods; German version CEN/TS 16800:2020
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
NS-EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
DANSK DS/EN ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
DANSK DS/ISO 16140-5:2020 Microbiology of the food chain – Method validation – Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
DIN EN ISO 16140-7 E:2023 Draft Document - Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023); German and English version prEN ISO 16140-7:2023
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/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 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
NS-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)
AENOR UNE-EN ISO 16140-2:2016 Microbiology of the food chain. Method validation. Part 2: Protocol for the validation of alternative (registered) methods against reference methods. (ISO 16140-2:2016).
DANSK DS/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)
DANSK DS/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)
DIN EN ISO 16140-4 E:2018 Draft Document - Microbiology of the food chain - Method validation - Part 4: Protocol for single-laboratory (in-house) method validation (ISO/DIS 16140-4:2017); German and English version prEN ISO 16140-4:2017
NS-ENV ISO 13843:2001 Water quality — Guidance on validation of microbiological methods (ISO/TR 13843:2000)
DANSK DS/ISO 16140-6:2019 Microbiology of the food chain – Method validation – Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
DANSK DS/EN ISO 16140/A1:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
AWWA WQTC71481 Statistical Consideration for Validating a New Microbial Analysis Method
BS EN ISO 16140:2003 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
DANSK DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
DIN EN ISO 16140-5 E:2018 Draft Document - Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation of non-proprietary methods (ISO/DIS 16140-5:2017); German and English version prEN ISO 16140-5:2017
DANSK DS/EN ISO 16140-6:2019 Microbiology of the food chain – Method validation – Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
DIN EN ISO 16140-4/A1 E:2023 Draft Document - 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 16140-4:2020/DAM 1:2023); German an...
DIN EN ISO 16140-3 E:2018 Draft Document - Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference and validated alternative methods implemented in a single laboratory (ISO/DIS 16140-3:2017); German and English version prEN ISO 16...
DANSK DS/EN ISO 16140-1:2016 Microbiology of the food chain – Method validation – Part 1: Vocabulary (ISO 16140-1:2016)
AENOR UNE-EN ISO 16140-1:2016 Microbiology of the food chain. Method validation. Part 1: Vocabulary. (ISO 16140-1:2016).
NS-EN ISO 16140-1:2016 Microbiology of the food chain — Method validation — Part 1: Vocabulary (ISO 16140-1:2016)
NS-EN ISO 16140-6:2019 Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
DIN EN ISO 16140-2 E:2013 Draft Document - Microbiology of food and animal feed - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO/DIS 16140-2:2012); German version prEN ISO 16140-2:2012
NS-EN 13631-10:2003 Explosives for civil uses — High explosives — Part 10: Method for the verification of the means of initiation
DANSK DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
AWWA WQTC69473 USEPA Guidance Document for Microbiological Methods Validation
NS-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
DIN EN ISO 16140-6 E:2018 Draft Document - Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO/DIS 16140-6:2017); German and English version prE...
AENOR UNE-EN ISO 16140:2003 Microbiology of the foods for animal and human use. Alternative methods validation protocol (ISO 16140:2003).
AENOR UNE-EN ISO 16140/A1:2003 Microbiology of the foods for animal and human use. Alternative methods validation protocol (ISO 16140:2003).
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
DIN EN ISO 20072 E:2013 Draft Document - Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013

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
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)
EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
prEN ISO 16140-7 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023)
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)
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)
EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
EN ISO 20072:2010 Aerosol drug delivery device design verification - Requirements and test methods
EN ISO 16140-4:2020/prA1 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 4:2020/DAM 1:2023)
EN ISO 16140-6:2019 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
prEN 13631-10-2021 Explosives for civil uses - Explosives - Part 10: Method for the verification of the means of initiation of explosives
EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary

Danish Standards Foundation

DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
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/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/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
DS/EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
DS/EN ISO 16140/A1:2011 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1
DS/ENV ISO/TR 13843:2001 Water quality - Guidance on validation of microbiological methods

Lithuanian Standards Office

LST CEN/TS 16800-2021 Guideline for the validation of physico-chemical analytical methods
LST EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
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)
LST 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)
LST EN ISO 16140:2004 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
LST EN 13631-10-2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation

IT-UNI

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

PL-PKN

PN-EN ISO 16140-4-2021-01 E Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
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)
PN-EN ISO 16140-5-2021-01 E Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for nonproprietary methods (ISO 16140-5:2020)

AT-ON

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)
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 16140-5:2021 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)

CH-SNV

SN 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)
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)
SN EN ISO 16140-5:2021 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
SN EN ISO 16140-6:2021 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)

GSO

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
BH GSO ISO 16140-1:2022 Microbiology of the food chain — Method validation — Part 1: Vocabulary
GSO ISO 16140-1:2021 Microbiology of the food chain — Method validation — Part 1: Vocabulary
OS GSO ISO 16140:2014 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
BH GSO ISO 16140:2016 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods

Korean Agency for Technology and Standards (KATS)

KS P ISO 20072:2021 Aerosol drug delivery device design verification —Requirements and test methods
KS I ISO TR 13843-2021 Water quality－Guidance on validation of microbiological methods
KS I ISO TR 13843-2007(2012) Water quality－Guidance on validation of microbiological methods

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)

KR-KS

KS P ISO 20072-2021 Aerosol drug delivery device design verification —Requirements and test methods

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)
DIN EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

American Society for Testing and Materials (ASTM)

ASTM G20-88(2002) Standard Test Method for Chemical Resistance of Pipeline Coatings
ASTM G20-10 Standard Test Method for Chemical Resistance of Pipeline Coatings
ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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

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

RU-GOST R

GOST ISO 16140-2011 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
GOST 32421-2013 Classification of chemicals which hazard is caused by physical and chemical properties. Test methods of explosives

TH-TISI

TIS 2164-2004 Microbiology of food and animal feeding stuffs.protocol for the validation of alternative methods

ET-QSAE

ES 542-2000 Drug Thin Layer Chromatography Test Methods

HU-MSZT

MSZ 3780/15.lap-1960 Industrial Explosives Detection Methods Ammonia Explosives and Explosives Classification Chemical Experiments

Indonesia Standards

SNI ISO/TR 13843:2011 Water quality - Guidance on validation of microbiological methods

CEN - European Committee for Standardization

ENV ISO 13843:2001 Water Quality - Guidance on Validation of Microbiological Methods

Others: