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Validation methodology

Validation methodology, Total:98 items.

In the international standard classification, Validation methodology involves: Applications of information technology, Optics and optical measurements, Microbiology, Water quality, General methods of tests and analysis for food products, Quality, Power stations in general, Burners. Boilers, Safety of machinery, Products of the chemical industry.


British Standards Institution (BSI), Validation methodology

  • BS ISO/IEC 10373-9:2011 Identification cards. Test methods. Optical memory cards. Holographic recording method
  • 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 EN ISO 16140-1:2016 Microbiology of the food chain. Method validation. Vocabulary
  • 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
  • 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 16140-5:2020 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 16140-3:2021 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

RU-GOST R, Validation methodology

  • GOST 8.046-1985 State system for ensuring the uniformity of measurements. Optical dividing heads. Verification methods
  • GOST ISO 16140-2011 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods

Danish Standards Foundation, Validation methodology

  • DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
  • DS/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
  • DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
  • 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/A1:2011 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1

IT-UNI, Validation methodology

Lithuanian Standards Office , Validation methodology

  • 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 16140-5:2020 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 16140-3:2021 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 16140:2004 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

Association Francaise de Normalisation, Validation methodology

  • XP T90-800*XP CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
  • NF V08-103-1*NF EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1 : vocabulary
  • NF EN ISO 16140-1:2016 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 1 : vocabulaire
  • 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 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
  • NF EN ISO 16140-4:2020 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4 : protocole pour la validation de méthodes dans un seul laboratoire
  • NF E38-350:1995 Heat exchangers. Verification methods for thermodynamic performance of power plant condensers.
  • 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 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2 : protocole pour la validation de méthodes alternatives (commerciales) par rapport à une méthode de référence
  • NF EN ISO 16140-3:2021 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 3 : protocole pour la vérification dans un seul laboratoire de méthodes de référence et de méthodes alternatives validées
  • NF EN ISO 16140-6:2019 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 6 : protocole pour la validation de méthodes alternatives (commerciales) pour la confirmation microbiologique et le typage
  • 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 16140-5:2020 Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 5 : protocole pour la validation interlaboratoires de méthodes non commerciales par plan factoriel

European Committee for Standardization (CEN), Validation methodology

  • 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 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
  • 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 16140-3:2021 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 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
  • 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)

ES-UNE, Validation methodology

  • 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 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
  • 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 16140-5:2021 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 16140-3:2021 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 16140-6:2020 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)

海关总署, Validation methodology

  • SN/T 5326.2-2020 Guidelines for Validation of Professional Analytical Methods for Imported and Exported Food and Cosmetics Part 2: Chemical Methods

Shanxi Provincial Standard of the People's Republic of China, Validation methodology

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

International Organization for Standardization (ISO), Validation methodology

  • ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
  • ISO 16140-4:2020 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
  • ISO/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
  • 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 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary 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 16140-2:2016/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 16140-4:2020/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 16140-6:2019 Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
  • ISO 14123-2:2015 Safety of machinery - Reduction of risks to health resulting from hazardous substances emitted by machinery - Part 2: Methodology leading to verification procedures

German Institute for Standardization, Validation methodology

  • 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 16140-4:2020-12 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 16140-5:2020-12 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 16140-2:2016-11 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 16140-7:2023-05 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 16140-3:2021-06 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 16140-2:2016 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 16140-3:2018 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 16140-4:2020 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 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 16140-5:2020 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

Professional Standard - Certification and Accreditation, Validation methodology

  • RB/T 190-2015 Validation procedures for chemical analysis methods of gold in chemical mines

Professional Standard - Agriculture, Validation methodology

  • SN/T 5326.5-2023 Guidelines for Validation of Professional Analytical Methods for Import and Export of Food and Cosmetics Part 5: Immunological Methods
  • GB 5009.295-2023 General rules for validation of national food safety standards chemical analysis methods

AT-ON, Validation methodology

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

CH-SNV, Validation methodology

  • 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 16140-5:2021 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 16140-3:2021 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 16140-6:2021 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)

PL-PKN, Validation methodology

  • 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 16140-5-2021-01 E Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for nonproprietary methods (ISO 16140-5:2020)
  • 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)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Validation methodology

  • GB/T 32465-2015 Requirements for verification & validation of detection methods and internal quality control on chemical analysis
  • GB/T 18569.2-2001 Safety of machinery--Reduction of risks to health from hazardous substances emitted by machinery--Part 2: Methodology leading to verification procedures
  • GB/T 32467-2015 Verification and validation of methods and internal quality contorl on chemical analysis.Terms and definitions

VN-TCVN, Validation methodology

  • TCVN 6722-2-2002 Safety of machinery.Reduction of risk to health from hazardous subtances emitted by machinery.Part 2: Methodology leading to verification procedures

Korean Agency for Technology and Standards (KATS), Validation methodology

  • KS B ISO 14123-2:2002 Safety of machinery－ Reduction of risks to health from hazardous substances emitted by machinery-Part 2 : Methodology leading to verification procedures

Standard Association of Australia （SAA）, Validation methodology

  • 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)

TH-TISI, Validation methodology

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

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, Validation methodology

  • GB/T 35655-2017 Guideline for verification and validation of chemical analysis method and internal quality control—Chromatography

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