Validation of biological activity methods of antibody drugs

Validation of biological activity methods of antibody drugs, Total:421 items.

The international standard classification for "Validation of biological activity methods of antibody drugs" includes: Pesticides and other agrochemicals , Medical Sciences and health care facilities in general , Surface active agents , Biology. Botany. Zoology , Refractories , Water quality .

The Chinese standard classification for "Validation of biological activity methods of antibody drugs" includes: Pesticide management and application method , Pesticide , Medical science , Basic standards and general methods for surface active agent , Fireproof material in general , Environmental sanitation , Marking, packaging, transport and storage in general , Medical apparatus and devices in general , Sanitation in general , Health quarantine , Hygiene, safety and labor protection .

Professional Standard - Agriculture

333药典三部-2020 Biological activity-potency assay 3522 human erythropoin biological activity assay in vivo
283药典四部-2020 3500 Biological activity-potency assay 3525 Recombinant human granulocyte-stimulating factor biological activity assay
158药典四部-2015 1200 Bioactivity Determination Method 1201 Antibiotic Microbiological Test Method
324药典三部-2020 Biological activity-potency determination method 3513 Diphtheria antibody titer determination method in human immunoglobulin
265药典三部-2015 Bioassays 3410 Anticomplement Activity Assays General 110
335药典三部-2020 Biological Activity-Potency Assay 3524 Human Interleukin-2 Biological Activity Assay
282药典四部-2020 3500 Biological Activity-Potency Assay 3524 Recombinant Human Interleukin-2 Biological Activity Assay
309药典三部-2015 Biological activity-potency assay 3527 Recombinant bovine basic fibroblast growth factor biological activity assay general rules 136
304药典三部-2015 Biological Activity - Potency Assay 3522 General Rules for In vivo Biological Activity Assay of Recombinant Human Erythropoin 132
295药典四部-2015 3500 Biological Activity-Potency Assay 3532 Recombinant Human Interleukin-11 Biological Activity Assay
292药典四部-2015 3500 Biological Activity-Potency Assay 3529 Recombinant Streptokinase Biological Activity Assay
310药典三部-2015 Biological Activity - Potency Assay 3528 Recombinant Human Epidermal Growth Factor Biological Activity Assay General Rules 136
277药典四部-2015 3500 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
331药典三部-2015 Technical Guideline 9201 General Guidelines for the Validation of Alternative Methods for Microbiological Testing of Drugs 216
172药典四部-2015 1200 Bioactivity Assay 1217 Luteinizing Hormone Bioassay
1837药典一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products
288药典四部-2020 3500 biological activity-potency assay 3530 mouse nerve growth factor biological activity assay
287药典四部-2015 3500 Biological Activity-Potency Assay 3524 Recombinant Human Interleukin-2 Biological Activity Assay
农业部630号公告-11-2006 Technical guidelines for validation of analytical methods for quality control of veterinary chemicals
293药典四部-2020 3500 Biological Activity-Potency Assay 3535 Conbercept Biological Activity Assay
160药典四部-2020 1200 Bioactivity Assay 1217 Luteinizing Hormone Bioassay
281药典四部-2020 3500 Biological Activity-Potency Assay 3523 Interferon Biological Activity Assay
288药典四部-2015 3500 Biological activity-potency assay 3525 Recombinant human granulocyte-stimulating factor biological activity assay
345药典三部-2020 Biological Activity-Potency Assay 3535 Conbercept Biological Activity Assay
337药典三部-2020 Biological Activity-Potency Assay 3526 Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
农业部1425号公告-12-2010 Guiding principles for field test techniques for efficacy evaluation of anti-ectoparasite drugs for pets
334药典三部-2020 Biological Activity-Potency Assay 3523 Interferon Biological Activity Assay
340药典三部-2020 Biological Activity-Potency Assay 3530 Mouse Nerve Growth Factor Biological Activity Assay
287药典四部-2020 3500 Biological Activity-Potency Assay 3529 Recombinant Streptokinase Biological Activity Assay
2421药典二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
NY/T 4186-2022 Chemical pesticide-Guideline for fish,early-life stage toxicity test
293药典四部-2015 3500 biological activity-potency assay 3530 mouse nerve growth factor biological activity assay
146药典四部-2020 1200 Bioactivity Determination Method 1201 Antibiotic Microbiological Test Method
285药典四部-2020 3500 Biological activity-potency assay 3527 Recombinant bovine basic fibroblast growth factor biological activity assay
312药典三部-2015 Biological Activity - Potency Assay 3530 Mouse Nerve Growth Factor Biological Activity Assay General Rules 137
343药典四部-2020 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
305药典三部-2015 Biological activity-potency assay 3523 General principles of interferon biological activity assay 132
294药典四部-2015 3500 Biological Activity-Potency Assay 3531 Nimotuzumab Biological Activity Assay
341药典三部-2020 Biological Activity-Potency Assay 3531 Nimotuzumab Biological Activity Assay
311药典三部-2015 Biological Activity - Potency Assay 3529 Recombinant Streptokinase Biological Activity Assay General Rules 137
362药典三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
280药典四部-2020 3500 Biological activity-potency assay 3522 Recombinant human erythropoin in vivo biological activity assay
324药典四部-2015 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
农业部1425号公告-11-2010 Technical guidelines for efficacy evaluation test of anti-ectoparasitic drugs for pets
859兽药典一部-2015 Appendix Contents 1200 Biological Activity Determination Method 1201 Antibiotic Microbiological Test Method
307药典三部-2015 Biological activity-potency assay 3525 Recombinant human granulocyte-stimulating factor biological activity assay general rules 134
286药典四部-2015 3500 Biological Activity-Potency Assay 3523 Interferon Biological Activity Assay
175药典四部-2015 1200 Bioactivity Determination Method 1401 Radiopharmaceutical Testing Method
338药典三部-2020 Biological activity-potency assay 3527 bovine basic fibroblast growth factor biological activity assay
364药典三部-2020 Guiding Principle 9401 Guiding Principles for Validation of Bioactivity/Potency Assay Methods for Biological Products
163药典四部-2020 1200 Bioactivity Determination Method 1401 Radiopharmaceutical Testing Method
339药典三部-2020 Biological Activity-Potency Assay 3528 Human Epidermal Growth Factor Biological Activity Assay
290药典四部-2015 3500 Biological activity-potency assay 3527 Recombinant bovine basic fibroblast growth factor biological activity assay
358药典四部-2020 9000 Guidelines 9401 Guidelines for the Validation of Bioactivity/Potency Determination Methods for Biological Products
246药典四部-2015 3400 Bioassay 3410 Anticomplement Activity Assay
290药典三部-2020 Bioassay 3410 Anticomplement Activity Assay
285药典四部-2015 3500 Biological activity-potency assay 3522 Recombinant human erythropoin in vivo biological activity assay
239药典四部-2020 3400 Bioassay 3410 Anticomplement Activity Assay
286药典四部-2020 3500 Biological Activity-Potency Assay 3528 Recombinant Human Epidermal Growth Factor Biological Activity Assay
243药典三部-2010 Appendix Ⅹ XB In vivo biological activity assay of recombinant human erythropoin
NY/T 1155.1-2006 Pesticides guidelines for laboratory bioactivity tests Part 1: Petri dish test for herbicide bioactivity
325药典三部-2020 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
336药典三部-2020 Biological Activity-Potency Assay 3525 Human Granulocyte Stimulating Factor Biological Activity Assay
289药典三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
314药典三部-2015 Biological Activity-Potency Assay 3532 Recombinant Human Interleukin-11 Biological Activity Assay General Rules 139
313药典三部-2015 Biological Activity - Potency Assay 3531 Nimotuzumab Biological Activity Assay General Rules 138
272药典四部-2020 3500 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
290药典四部-2020 3500 Biological Activity-Potency Assay 3532 Recombinant Human Interleukin-11 Biological Activity Assay
342药典三部-2020 Biological Activity-Potency Assay 3532 Human Interleukin-11 Biological Activity Assay
291药典四部-2015 3500 Biological Activity-Potency Assay 3528 Recombinant Human Epidermal Growth Factor Biological Activity Assay
289药典四部-2020 3500 Biological Activity-Potency Assay 3531 Nimotuzumab Biological Activity Assay
296药典三部-2015 Biological activity-potency assay 3514 Human immunoglobulin Fc fragment biological activity assay general rules 128
306药典三部-2015 Biological Activity - Potency Assay 3524 Recombinant Human Interleukin-2 Biological Activity Assay General Rules 134

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

GB/T 15818-2018 Test method for biodegradability of surfactants
GB/T 29567-2013 The bioassay method for flies’resistance to insecticides—Topical application method
GB/T 26350-2010 Test methods of fly resistance to insecticides—The bioassay methods for musca domestica
GB/T 42367-2023 Chemicals—Protozoan activated sludge inhibition test
GB/T 5750.9-2006 Standard examination methods for drinking water - Pesticides parameters
GB/T 15818-2006e Test method for biodegradability of surfactants
GB/T 35172-2017 Determination of corrosion resistance of refractories for cement kilns to CMSW
GB/T 15818-2006 Test method for biodegradability of surfactants
GB/T 38483-2020 Determination of antibacterial activity for microbial secondary metabolites. Inhibition zone method
GB/T 38480-2020 Determination of antifungal activity for microbial secondary metabolites. Mycelial growth rate method
GB/T 29566-2013 The bioassay methods for mosquitoesresistance to insecticides
GB/T 15818-2018(英文版) Test method for biodegradability of surfactants
GB/T 26352-2010 Test methods of cockroach resistance to insecticides—The bioassay methods for Blattella germanica
GB/T 26347-2010 Test methods of mosquito resistance to insecticides—Bioassay methods
GB/T 38096-2019 Determination of nematicidal activity for microbial antibiotic secondary metabolites—Immersion method

Professional Standard - Medicine

YY/T 0688.2-2024 Clinical laboratory testing and in vitro diagnostic systems - Performance evaluation of equipment for infectious pathogen susceptibility testing and antimicrobial susceptibility testing - Part 2: Performance evaluation of equipment for antimicrobial susce
YY/T 0688.1-2023 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 aerobic

未注明发布机构

CLSI M100 ED33-2023 CHINESE Antimicrobial susceptibility testing standards
CLSI M43-A-2011 Method for Antimicrobial Susceptibility Test of Human Mycoplasma
CLSI VET03-A-2006 Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline

Professional Standard - Hygiene

WS/T 248-2005 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

Professional Standard - Commodity Inspection

SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 3168-2012 Risk analysis for living modified organisms
SN/T 1750-2006 Determination of antibiotics residuses in animal derived food-MIA method
SN/T 5158-2019 Chemicals-BG1Luc estrogen receptor transactivation test method for identifying estrogen receptor agonists and antagonists
SN/T 3168-2022 Risk analysis for living modified organisms

Professional Standard - Ocean

HY/T 229-2018 Structure confirmation method of marine bioactive material of certified reference material

National Health Commission of the People's Republic of China

GB 26352-2010 Cockroach drug resistance detection method, German cockroach bioassay
GB 4789.43-2016 National Food Safety Standard - Food Microbiological Examination -Determination of Antibacterial Activity of Microbe-source Enzyme

Group Standards of the People's Republic of China

T/HBST 003-2023 Technical practice for microbiological safety evaluation of veterinary antibacterial
T/CSBM 0026-2022 In vitro mineralization test method of bioactive glass
T/TPPA 0004-2022 DPPH method for evaluating the in vitro antioxidant activity of traditional Chinese medicine injections

Taiwan Provincial Standard of the People's Republic of China

CNS 14384-3-1999 Protective gloces against chemicals and micro-organisms - Part 3:Determination of resistance to permeation by chemicals
CNS 9028-1983 Method of Test for Feed Additives: General Rules for Microbiological Determination of Antibotics
CNS 14384.3-1999 Protective gloces against chemicals and micro-organisms - Part 3:Determination of resistance to permeation by chemicals
CNS 14384-2-1999 Protective gloves against chemicals and micro-organisms - Part 2:Determination of resistance to penetration
CNS 14384.2-1999 Protective gloves against chemicals and micro-organisms - Part 2:Determination of resistance to penetration

National Metrological Technical Specifications of the People's Republic of China

JJF 1974-2022 Quantitative Measurement Method for Activity of Inoculum in Biodegradation Tests

Professional Standard - Light Industry

QB 938-1984 Test method for biodegradability of anionic surfactants
QB 939-1984 Test method for biodegradability of nonionic surfactants

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

GJB 771.104-1991 Gunpowder performance test methods Compressive strength test

Shaanxi Provincial Standard of the People's Republic of China

DB61/T 1018-2016 Performance test method of bioactive oil displacement agent

Spanish Association for Standardization (UNE)

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 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 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
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 16140-6:2020 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 16140-2:2016 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)
AENOR 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 an...
UNE-EN ISO 20776-1:2021 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 aer...
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).
AENOR UNE-EN ISO 16140-1:2016 Microbiology of the food chain. Method validation. Part 1: Vocabulary. (ISO 16140-1:2016).
UNE-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

German Institute for Standardization

DIN 58940-3 Beiblatt 2:1989 Medical microbiology - Test method for susceptibility of bacterial pathogens (except tuberculosis) to antibiotic drugs - Agar diffusion test
DIN 58940-84:2002-10 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 84: Microdilution; Special requirements for testing of fungi against antifungal agents
DIN 58940-2:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Text in German and English
DIN EN ISO 20776-1 E:2018-08 Performance evaluation of infectious agent susceptibility testing and antimicrobial susceptibility testing devices Part 1: Liquid culture medium microdilution reference method for testing the in vitro activity of antimicrobial agents against fast-growing
DIN 58940-2:2007-10 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Text in German and English
DIN 58940-2 Beiblatt 2:1990 Methods for determination of antibiotic susceptibility in medical microbiology
DIN 58940-10 Beiblatt 1:1998 Medical microbiology - Antimicrobial susceptibility testing methods - Part 10: Criteria for the in vitro effectiveness assessment of new antimicrobial agents
DIN 58940-4 Supplement 1:2004 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 4: Evaluation classes of the minimum inhibitory concentration - MIC-breakpoints of antibacterial agents
DIN 58940-4 Beiblatt 1:2010-05 Medical microbiology — Susceptibility testing of microbial pathogens against chemotherapeutic agents
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 58940-3 Beiblatt 1:1989 Methods for antibiotic susceptibility testing in medical microbiology (nontuberculous mycobacteria)
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 58940-3 Beiblatt 1:2000-01 Medical microbiology methods - Test methods for determining the susceptibility of microbial pathogens to chemotherapeutic agents - Part 3: Agar diffusion test
DIN CEN/TR 17296:2019*DIN SPEC 13268:2019 Distinguishing between active and inactive substances in chemical disinfectants and antimicrobial agents
DIN 58940-1:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
DIN EN ISO 16140-7 E:2023-05 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
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
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 16140-1:2016-11 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016); German version EN ISO 16140-1:2016
DIN EN ISO 16140-6:2020-04 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 16140-5:2020-12 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 58940-3 Supplement 2:1989 Medical microbiology; methods for the determination of susceptibility of pathogens (except mycobacteria) to antimicrobial agents; agar diffusion test; zone diameters with control strains
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 16140-3:2021-06 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 CEN/TS 17035:2017*DIN SPEC 19280:2017 Surfactants Bio-based surfactants Requirements and test methods
DIN 58959-14 Beiblatt-1 E:1991-11 Medical microbiology: quality assurance in medical microbiological laboratories; use of control strains for antibiotic susceptibility testing of aerobic pathogens
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 20776-1:2020-12 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 aer...
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 58940-2 Supplement 2:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Carrier loads and values required for drawing a standard curve
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 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
DIN 58940-2 Supplement 2:2002 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Carrier loads and values required for drawing a standard curve
DIN EN 17035:2018-09 Draft Document - Surface Active Agents - Bio-based surfactants - Requirements and test methods; German and English version prEN 17035:2018
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 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 16140-3:2021 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 16140-2/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 16140-4 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
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 16140-4:2018-02 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
DIN EN ISO 16140-4/A1 E:2023-08 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 58940-4 Beiblatt 1:2004-02 Medical microbiology - Antimicrobial susceptibility testing of antimicrobial pathogens - Part 4: Minimum inhibitory concentration evaluation scale - Antimicrobial MIC cut-off values
DIN 58940-3 Supplement 1:2000 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 3: Agar diffusion test; data for the interpretation of inhibition zone diameters
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 16140-3:2018 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 16140-7:2025-04 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024); German version EN ISO 16140-7:2024
DIN 58940-3:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 3: Agar diffusion test; Text in German and English
DIN EN ISO 16140-6:2018-02 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...
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...
DIN EN ISO 16140-1 E:2013-01 Validation of microbiological methods in the food chain Part 1: Glossary (draft)
DIN 58940-20:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 20: Codes for antimicrobial agents
DIN 58940-8:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 8: Microdilution; General method-specific requirements
DIN EN 12353:2013-04 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
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
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
DIN EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
DIN 58940-5 Beiblatt 1:1989 Methods for determination of susceptibility of bacterial pathogens (except tuberculosis bacilli) to antimicrobial drugs by agar dilution method (macrodilution method) Minimum inhibitory concentration of control strains
DIN 58944-1 Beiblatt-1 E:1991-11 Medical microbiology; method for the determination of susceptibility of anaerobic pathogenic bacteria to chemotherapeutic agents

GCC Standardization Organization

GSO ISO 21703:2024 Surface active agents — Microbiology — Microbiological test methods for liquid hand dishwashing
GSO ISO 16140-4:2024 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
BH GSO ISO 16140-4:2024 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
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
GSO ISO 16140-1:2021 Microbiology of the food chain — Method validation — Part 1: Vocabulary
BH GSO ISO 16140-3:2024 Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
BH GSO ISO 20776-1:2024 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 ae...
BH GSO ISO 16140-6:2024 Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
BH GSO ISO 16140-5:2024 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
GSO ISO 16140-5:2024 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
GSO ISO 16140-6:2024 Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

British Standards Institution (BSI)

BS EN ISO 16140-7:2024 Microbiology of the food chain. Method validation - Protocol for the validation of identification methods of microorganisms
BS ISO 21703:2019 Surface active agents. Microbiology. Microbiological test methods for liquid hand dishwashing
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 16140-6:2019 Microbiology of the food chain. Method validation - Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
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 16140-2:2016 Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods against a reference method
BS EN ISO 16140-1:2016 Microbiology of the food chain. Method validation. Vocabulary
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 16140-4:2020 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 20776-1:2020 Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing…
BS DD 177:1988 Method of test for the antimicrobial activity of disinfectants in food hygiene
PD CEN/TS 17035:2017 Surface Active Agents - Bio-based surfactants - Requirements and test methods
BS EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods
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
BS EN ISO 16140:2003 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
BS ISO 4768:2023 Measurement method of anti-biofilm activity on plastic and other non-porous surface
24/30492545 DC BS EN ISO 16140-4:2020/Amd 2 Microbiology of the food chain. Method validation - Part 4: Protocol for method validation in a single laboratory. Amendment 2: Protocol for single-laboratory validation of identification methods of microorganisms
18/30370871 DC BS EN ISO 20776-1. 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 r...
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
24/30488611 DC BS ISO 16140-3:2021/A1 Microbiology of the food chain — Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
BS PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
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 ISO 21899:2020 Biotechnology. Biobanking. General requirements for the validation and verification of processing methods for biological material in biobanks

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 21703:2019 Surface active agents — Microbiology — Microbiological test methods for liquid hand dishwashing
ISO 16140-7:2024 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 16140-4:2020/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 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 16140-4:2020/DAmd 2 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 2: Protocol for single-laboratory validation of identification methods of microorganisms
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
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 16140-3:2021/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 16140-3:2021 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 4768:2023 Measurement method of anti-biofilm activity on plastic and other non-porous surfaces
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 4768:2004 Measurement method of anti-biofilm activity on plastic and other non-porous surfaces
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/FDIS 4768:1975 Measurement method of anti-biofilm activity on plastic and other non-porous surfaces
ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
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 9509:1989 Water quality; method for assessing the inhibition of nitrification of activated sludge micro-organisms by chemicals and waste waters
ISO 19574:2022 Footwear and footwear components — Qualitative test method to assess antifungal activity (growth test)
ISO 21899:2020 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks

Standards Norway

NS-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 aer...
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)
NS-ENV ISO 13843:2001 Water quality — Guidance on validation of microbiological methods (ISO/TR 13843:2000)
NS-EN 17035:2021 Surface active agents – Bio-based surfactants – Requirements and test methods
NS-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 an...
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)
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)
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)
NS-EN ISO 16140-1:2016 Microbiology of the food chain — Method validation — Part 1: Vocabulary (ISO 16140-1:2016)
NS-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 D6530-00(2006) Standard Test Method for Total Active Biomass in Cooling Tower Waters (Kool Kount Assay; KKA)
ASTM E3151-18(2025) Standard Test Method for Determining Antimicrobial Activity and Biofilm Resistance Properties of Tube, Yarn, or Fiber Specimens
ASTM D6530-00 Standard Test Method for Total Active Biomass in Cooling Tower Waters (Kool Kount Assay; KKA)
ASTM E2149-20 Standard Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions
ASTM E3151-18 Standard Test Method for Determining Antimicrobial Activity and Biofilm Resistance Properties of Tube, Yarn, or Fiber Specimens
ASTM E2149-13 Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions
ASTM D684-57 Methods of Test for Resistance of Textile Materials to Microorganisms
ASTM E1428-15a Standard Test Method for Evaluating the Performance of Antimicrobials in or on Polymeric Solids Against Staining by Streptomyce species (A Pink Stain Organism)
ASTM E2500-25 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach
ASTM RR-E35-1011 2018 E3151-Test Method For Determining the Antimicrobial Activity and Biofilm Resistance Properties of Tube, Yarn or Fiber Specimens
ASTM E1625-94 Standard Test Method for Determining Biodegradability of Organic Chemicals in Semi-Continuous Activated Sludge (SCAS)
ASTM STP 673-1979 Methodology for Biomass Determinations and Microbial Activities in Sediments

Association Francaise de Normalisation

NF EN ISO 16140-7:2024 Microbiology of the food chain - Method validation - Part 7 : protocol for the validation of identification methods of microorganisms
NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: protocol for method validation in a single laboratory
NF V08-103-5*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 16140-6:2019 Microbiology of the food chain - Validation of methods - Part 6: protocol for the validation of alternative (commercial) methods for microbiological confirmation and typing
NF S92-053-1*NF 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 aerob
NF V08-103-4/A1*NF EN ISO 16140-4/A1:2024 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
NF EN ISO 16140-4/A1:2024 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
NF EN ISO 16140-1:2016 Microbiology of the food chain - Validation of methods - Part 1: vocabulary
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 16140-3:2021 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 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 16256:2021 Medical biology analysis laboratories and in vitro diagnostic systems - Reference method of microdilution in liquid medium to test the in vitro activity of antimicrobial agents in relation to the yeasts involved ...
NF V08-103-1*NF EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1 : vocabulary
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 V08-105:2010 Microbiology for food and animal feeding stuffs - Guidelines of impedancemetry for microbiological examinations.
NF G62-029*NF EN ISO 19574:2022 Footwear and footwear components - Qualitative test method to assess antifungal activity (growth test)
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

Danish Standards Foundation

DANSK DS/ISO 16140-7:2024 Microbiology of the food chain – Method validation – Part 7: Protocol for the validation of identification methods of microorganisms
DANSK DS/EN ISO 16140-7:2024 Microbiology of the food chain – Method validation – Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024)
DANSK DS/ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory
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
DANSK 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
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
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 17035:2021 Surface active agents – Bio-based surfactants – Requirements and test methods
DS/EN 17035:2021 Surface active agents – Bio-based surfactants – Requirements and test methods
DANSK DS/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 aer...
DANSK DS/EN ISO 16140/A1:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
DANSK DS/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 aer...
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)
DANSK DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
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)
DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
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)
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)
DANSK DS/EN ISO 16140-1:2016 Microbiology of the food chain – Method validation – Part 1: Vocabulary (ISO 16140-1:2016)
DS/EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration
DS/ENV ISO/TR 13843:2001 Water quality - Guidance on validation of microbiological methods

PL-PKN

PN-EN ISO 20776-1-2021-01 E 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 aerob
PN E04160 ArkusZ37-1973 Elec?rlc cables Me?hods ot ?es?ing Test for resistance to the action of chemical subs?ances vapours
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)

Ente Nazionale Italiano di Unificazione

UNI 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
UNI EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory
UNI EN ISO 16140-4:2024 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory
UNI EN ISO 16140-2:2024 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
UNI 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
UNI CEN/TS 17035:2017 Surface Active Agents - Bio-based surfactants - Requirements and test methods
UNI EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
UNI 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
EC 1-2022 UNI 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
UNI EN 17035:2021 Surface active agents - Bio-based surfactants - Requirements and test methods
UNI EN ISO 16140:2011 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
UNI 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
UNI EN ISO 16140:2005 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
EC 1-2011 UNI EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration
UNI EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
UNI EN ISO 19574:2022 Footwear and footwear components - Qualitative test method to assess antifungal activity (growth test)
UNI EN 13518:2006 Footwear - Test methods for uppers - Water resistance
UNI ENV ISO 13843:2003 Water quality - Guidance on validation of microbiological methods
UNI EN 1656:2001 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary field - Test method and requirements (phase 2/step 1)

Bureau of Indian Standards

IS 17113-4-2022 Microbiology of the Food Chain-Method Validation - Part 4 Protocol for Method Validation in a Single Laboratory
IS 17113-1-2019 Microbiology of the Food Chain —— Method Validation Part 1 Vocabulary
IS 17113-6-2022 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative proprietary methods for microbiological confirmation and typing procedures
IS 17113-3-2022 Microbiology of the Food Chain-Method Validation - Part 3 Protocol for the Verification of Reference Methods and Validated Alternative Methods in a Single Laboratory
IS/ISO 20776-1-2019 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 Aerobic B
IS 17113-5-2022 Microbiology of the Food Chain-Method Validation - Part 5 Protocol for Factorial Interlaboratory Validation for Non-Proprietary Methods
IS 17113-2-2019 Microbiology of the Food Chain —— Method Validation Part 2 Protocol for the Validation of Alternative ( Proprietary ) Methods against a Reference Method
IS 3856-2022 Method for testing flax fabrics for resistance to attack by micro-organisms

AT-ON

OENORM 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
ONORM EN 369-1993 Protective clothing - Protection against liquid chemicals -Test method: Resistance of materials to permeation by liquids
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)
ONORM EN 368-1993 Protective clothing for use against liquid chemicals -Test method: Resistance of materials to penetration by liquids
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)

IT-UNI

UNI EN ISO 20776-1:2021 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

CH-SNV

SN 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
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)

European Committee for Standardization (CEN)

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 16140-7:2024 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024)
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/prA1:2024 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory - Amendment 1: Validated identification methods of microorganisms - Technical protocol
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 16140-6:2019 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)
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 16140-5:2020 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
EN ISO 19574:2022 Footwear and footwear components - Qualitative test method to assess antifungal activity (growth test) (ISO 19574:2022)
EN ISO 16140-4:2020/prA2 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 2: Protocol for single-laboratory validation of identification methods of microorganisms (ISO 16140-4:2020/DAM 2:2024)
EN 368:1992 Protective clothing; protection against liquid chemicals; test method: resistance of materials to penetration by liquids
EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
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 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)

Gosstandart of Russia

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
GOST 34803-2021 Perfumery and cosmetic products. Methods for determining antimicrobial activity
GOST EN 12353-2023 Chemical disinfectants and antiseptics. Preservation of test microorganisms used to determine bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity..
GOST ISO 16140-2011 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
GOST 8.046-1985 State system for ensuring the uniformity of measurements. Optical dividing heads. Verification methods

IN-BIS

IS 1389-1984 Test method for antimicrobial invasion of cotton fabrics

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 16140-1:2022 Microbiology of the food chain — Method validation — Part 1: Vocabulary
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 21703:2024 Surface active agents — Microbiology — Microbiological test methods for liquid hand dishwashing
BH GSO ISO 16140:2016 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods

Lithuanian Standards Office

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)

Korean Agency for Technology and Standards (KATS)

KS I ISO 9509-2008(2018) Water quality－Method for assessing the inhibition of nitrification of activated sludge micro organisms by chemicals and wastewaters
KS P ISO 8871-4-2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods
KS P ISO 8871-4:2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods
KS P ISO 8871-4-2010(2016) Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 4：Biological requirements and test methods
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 I 3221-2007 Water quality－Evaluation of the aerobic biodegradability of organic compounds in an aqueous medium[Semi-continuous activated sludge method(SCAS)]
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 K 0693-2022 Test method for antibacterial activity of textile materials
KS J ISO 21899-2023 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
KS K 0693-2016 Test method for antibacterial activity of textile materials
KS K 0823-1995 Testing method for antimicrobial activity assessment of carpets
KS K 0693-2016(2021) Test method for antibacterial activity of textile materials
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
KS P 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
KS P 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

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 4659.4:1999 Guide to determining the equivalence of food microbiology test methods - Antibiotic tests

GOST

GOST 35116-2024 Enzyme preparations for the food industry of microbial origin. Method for determining antibiotic activity

South African Bureau of Standard

SANS 5550:2009 Potency of antibiotics - Microbiological agar diffusion method of assay (two-point technique)
SANS 5471:2006 Pesticides - Biological evaluation of the resistance of materials to termite attack

Swedish Institute for Standards

SS-EN ISO 16140-7:2024 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024, IDT)
SS-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)
SS-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)
SS-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

American Water Works Association (AWWA)

AWWA WQTC71481 Statistical Consideration for Validating a New Microbial Analysis Method
AWWA WQTC69473 USEPA Guidance Document for Microbiological Methods Validation

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 16140:2014 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
OS GSO ISO 22612:2013 Clothing for protection against infectious agents -- Test method for resistance to dry microbial penetration

CU-NC

NC 20-30-2-1988 Medical Sciences. School Hygiene. Physical Examination to Students. Determination of Audity Acuity. Testing Method
NC 90-19-16-1987 Metrological Assurance. Impedance Meters. Methods and Means of Verification

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)
AS 1095.3.5:1976 Microbiological methods for the dairy industry, Part 3.5: Methods of examination for specific groups of microorganisms - Psychrotrophic organisms

Japanese Industrial Standards Committee (JISC)

JIS K 6950:1994 Plastics -- Testing method for aerobic biodegradability by activated sludge

TH-TISI

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

CEN - European Committee for Standardization

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

Indonesia Standards

SNI ISO/TR 13843:2011 Water quality - Guidance on validation of microbiological methods
SNI 03-1768-1990 Aggregates for concrete, Test methods for reactive properties against alkalin by chemical method

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