USP Sterility Analytical Method Validation

USP Sterility Analytical Method Validation, Total:248 items.

The international standard classification for "USP Sterility Analytical Method Validation" includes: Pesticides and other agrochemicals , Other standards related to sterilization and disinfection , Sterilization and disinfection in general , Laboratory medicine , Quality management and quality assurance , Product and company certification. Conformity assessment .

The Chinese standard classification for "USP Sterility Analytical Method Validation" includes: Legal medical expert , Basic standards and general methods for pesticides , Hygiene, safety and labor protection , Public medical equipment , Medical apparatus and devices in general , Standardization and Quality Management .

未注明发布机构

DIN ISO 7210 E:2019-11 Routine analytical cigarette-smoking machine - Additional test methods for machine verification
DIN CEN/TS 17174:2018*DIN SPEC 10796:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
DIN CEN/TS 16800:2016*DIN SPEC 38402-61:2016 Guideline for the validation of physico-chemical analytical methods
CSA ISO 11737-2:2021 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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

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

Professional Standard - Commodity Inspection

SN/T 3122-2012 Test method for antibacterial capability of inorganic antibacterial agents

Professional Standard - Certification and Accreditation

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

Professional Standard - Agriculture

GB 5009.295-2023 National food safety standard - General rules for verification of chemical analysis methods
334药典四部-2020 9000 Guidelines 9101 Guidelines for Validation of Analytical Methods
GB 6697-1986 Analytical method of content for carbendazim technical
361药典三部-2020 Guideline 9101 Guidelines for Validation of Analytical Methods
CNAS-TRL-011-2020 Guidelines for Validation and Validation of Chemical Analysis Methods for Light Industrial Products

国家食品药品监督管理局

YY/T 1479-2016 Sterility test method for membrane filters
YY/T 1608-2018 Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits

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

GB/T 6697-1986 Analytical method of content for carbendazim technical
GB/T 32465-2015 Requirements for verification & validation of detection methods and internal quality control on chemical analysis
GB/T 18851.5-2005 Non-destructive testing - Penetrant testing - Part5: Means of verification
GB/T 19973.2-2005 Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process

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 35655-2017 Guideline for verification and validation of chemical analysis method and internal quality control—Chromatography
GB/T 27417-2017 Comformity assessment--Guidance on validation and verification of chemical analytical methods

Group Standards of the People's Republic of China

T/CECPA 002-2020 Evaluation and Validation Method for Nuclear Power Design and Safety Analysis Software
T/JMBX 0188.6-2021 Aromatherapy test methods Part 6: Mold and yeast test methods

海关总署

SN/T 5326.2-2020 Guideline on validation of test methods for food and cosmetics of import and export Part 2: Chemical method

Liaoning Provincial Standard of the People's Republic of China

DB21/T 3851-2023 Specification for verification of chromatographic analysis methods for quality and safety testing of livestock products

European Committee for Standardization (CEN)

EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
CEN/TR 16059:2010 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
PD CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
PD CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
PD CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
CEN ISO/TR 24094:2007 Analysis of natural gas - Validation methods for gaseous reference materials
EN ISO/TR 24094:2007 Analysis of natural gas - Validation methods for gaseous reference materials
CEN/TR 10345:2013 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

Association Francaise de Normalisation

XP V18-801*XP CEN/TS 17455:2020 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
FD CEN/TR 16059:2011 Analysis of food products - Performance criteria for validated single-laboratory mycotoxin analysis methods
XP CEN/TS 16800:2021 Guidelines for the validation of physicochemical analytical methods
NF ISO 12828-2:2020 Validation method for fire gas analyzes - Part 2: intralaboratory validation of quantification methods
XP CEN/TS 17455:2020 Animal feed - Sampling and analysis methods - Performance criteria for mycotoxin analysis methods validated in a single laboratory or following an interlaboratory test
NF X65-040-2*NF ISO 12828-2:2020 Validation method for fire gas analysis - Part 2 : Intralaboratory validation of quantification methods
XP T90-800*XP CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
XP ISO/TS 22176:2020 Cosmetics - Analytical methods - Development of a global approach for the validation of quantitative analytical methods
NF S98-118-2*NF EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process
FD V03-119*FD CEN/TR 16059:2011 Food analysis - Performance criteria for single laboratory validated of analysis for the determination of mycotoxins
XP V18-800*XP CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
NF EN ISO 11737-2:2020 Sterilization of health products - Microbiological methods - Part 2: sterility checks carried out during the definition, validation and maintenance of a sterilization process
NF V37-022:2013 Routine analytical cigarette-smoking machine - Additional test methods for machine verification
FD A06-002*FD CEN/TR 10345:2014 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
NF ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
NF X44-103:2006 Cleanrooms and associated controlled environments - Part 3 : test methods.
NF V37-022*NF ISO 7210:2019 Routine analytical cigarette-smoking machine - Additional test methods for machine verification

CEN - European Committee for Standardization

EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process

SCC

SN-CEN/TR 16059:2010 Food analysis — Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
DANSK DS/CEN/TR 16059:2011 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
SN-CEN/TS 17455:2020 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
BS PD CEN/TS 17455:2020 Animal feeding stuffs. Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
DIN CEN/TS 16800 E:2014 Draft Document - Guideline for the validation of analytical methods; German version FprCEN/TS 16800:2014
DANSK DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
SN-CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods
SN-CEN/TS 16800:2015 Guideline for the validation of physico-chemical analytical methods
DANSK DS/ISO 12828-2:2016 Validation methods for fire gas analyses -- Part 2: Intralaboratory validation of quantification methods
BS PD ISO/TS 22176:2020 Cosmetics. Analytical methods. Development of a global approach for validation of quantitative analytical methods
NS 4751:1976 Water analysis — Methods for bacteriological examination of potable water
UNE-EN ISO 11737-2:2000 STERILIZATION OF MEDICAL DEVICES. MICROBIOLOGICAL METHODS. PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS. (ISO 11737-2:1998)
DIN CEN/TS 16800:2024 Guideline for the validation of physico-chemical analytical methods; German version CEN/TS 16800:2020
NS-EN ISO 11737-2:2000 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
07/30157769 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
DANSK DS/CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis – Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
DANSK DS/ISO 11737-2:2020 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
AAMI TIR76:2021 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
BS ISO 11726:2004 Solid mineral fuels. Guidelines for the validation of alternative methods of analysis
DANSK DS/CEN ISO/TR 24094:2008 Analysis of natural gas - Validation methods for gaseous reference materials
AWWA WQTC71481 Statistical Consideration for Validating a New Microbial Analysis Method
DANSK DS/EN ISO 11737-2:2020 Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
AENOR UNE-EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
NS-EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
NS-EN ISO 11737-2:2020 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
DANSK DS/ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
10/30201045 DC BS ISO 12787. Cosmetics. Analytical methods. Validation criteria for analytical results using chromatographic techniques
DIN EN ISO 11737-2 E:2018 Draft Document - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018); German and English version prEN ISO 1173...
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
SN-CEN/TR 10345:2008 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
DANSK DS/CEN/TR 10345:2013 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
NS 4714:1990 Water analysis — Coliform bacteria, thermotolerant coliform bacteria and presumptive E.Coli — MPN-method
BS PD CEN/TR 10345:2013 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
SN-CEN/TR 10345:2013 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
BS PD ISO/TS 7013:2023 Water quality. Guidance and requirements for designing an interlaboratory trial for validation of analytical methods
DANSK DS/CEN/CR 13505:1999 Food analysis - Biotoxins - Criteria for analytical methods of mycotoxins
SN-CR 13505:1999 Food analysis — Biotoxins — Criteria of analytical methods of mycotoxins
DANSK DS/ISO/TS 7013:2023 Water quality – Guidance and requirements for designing an interlaboratory trial for validation of analytical methods
DANSK DS/ISO 7210:2018 Routine analytical cigarette-smoking machine – Additional test methods for machine verification
DANSK DS/ISO 10705-3:2004 Water quality - Detection and enumeration of bacteriophages - Part 3: Validation of methods for concentration of bacteriophages from water
AWWA WQTC62457 Interlaboratory Validation of EPA Method 1103.1 (mTEC) for E. coli in Wastewater Effluent
AWWA MTC57549 Validation of Membrane Integrity Methods in a Challenge Test with Bacillus subtillis
AWWA WQTC60600 Interlaboratory Validation of US EPA Method 1600 (mEI) for Enterococci in Wastewater Effluent
AENOR UNE 77241:2001 Gas analysis. Verification of calibration gas mixtures by a comparison method.

Danish Standards Foundation

DS/CEN/TR 16059:2011 Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins
DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
DS/EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
DS/CEN ISO/TR 24094:2008 Analysis of natural gas - Validation methods for gaseous reference materials
DS/ISO 12787:2012 Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques
DS/CEN/TR 10345:2008 Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
DS/ISO 10705-3:2004 Water quality - Detection and enumeration of bacteriophages - Part 3: Validation of methods for concentration of bacteriophages from water
DS/CEN/CR 13505:1999 Food analysis - Biotoxins - Criteria for analytical methods of mycotoxins
DS/ISO 12828-1:2012 Validation method for fire gas analysis - Part 1: Limits of detection and quantification
DS/ISO 7210:2013 Routine analytical cigarette-smoking machine - Additional test methods for machine verification

Compressed Gas Association (U.S.)

CGA M-6-2013 Guideline for analytical method volidation
CGA P-8.2-2013 Guideline for validation of air separation unit and cargo tank filling for oxygen usp and nitrogen NF

German Institute for Standardization

DIN CEN/TS 17455:2020-07 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins; German version CEN/TS 17455:2020
DIN EN ISO 11737-2:2020-07 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
DIN CEN/TS 16800:2016-03*DIN SPEC 38402-61:2016-03 Guideline for the validation of physico-chemical analytical methods (CEN/TS 16800:2015); German version CEN/TS 16800:2015
DIN CEN/TS 17174:2018-10*DIN SPEC 10796:2018-10 Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals; German version CEN/TS 17174:2018
DIN EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
DIN ISO 7210:2020-06 Routine analytical cigarette-smoking machine - Additional test methods for machine verification (ISO 7210:2018)
DIN EN 15305 Berichtigung 1:2009 Non-destructive testing - Test method for residual stress analysis by X-ray diffraction; German version EN 15305:2008, Corrigendum to DIN EN 15305:2009-01; German version EN 15305:2008/AC:2009
DIN-Fachbericht 82:1999 Food analysis - Biotoxins - Criteria of analytical methods of mycotoxins; trilingual edition of CR 13505:1999
DIN EN 17697:2021-08 Animal feeding stuffs: Methods of sampling and analysis - PFGE typing of Lactobacilli, Pediococci, Enterococci and Bacilli; German and English version prEN 17697:2021 / Note: Date of issue 2021-07-23
DIN 10186:2022-11 Microbiological analysis of milk - Enumeration of yeasts and moulds - Reference method

ES-UNE

UNE-CEN/TS 17455:2021 Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
UNE-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 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
UNE-CEN ISO/TR 24094:2012 IN Analysis of natural gas - Validation methods for gaseous reference materials (ISO/TR 24094:2006)
UNE-ISO 10705-3:2021 Water quality. Detection and enumeration of bacteriophages. Part 3: Validation of methods for concentration of bacteriophages from water

British Standards Institution (BSI)

PD CEN/TS 17455:2020 Animal feeding stuffs. Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
BS ISO 12828-2:2016 Validation methods for fire gas analyses. Intralaboratory validation of quantification methods
PD ISO/TS 22176:2020 Cosmetics. Analytical methods. Development of a global approach for validation of quantitative analytical methods
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 PD CEN/TS 17174:2018 Animal feeding stuffs: Methods of sampling and analysis. Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals
BS ISO 11726:2017 Solid mineral fuels. Guidelines for the validation of alternative methods of analysis
PD CEN ISO/TR 24094:2007 Analysis of natural gas. Validation methods for gaseous reference materials
BS PD CEN ISO/TR 24094:2007 Analysis of natural gas — Validation methods for gaseous reference materials
BS ISO 7210:2013 Routine analytical cigarette-smoking machine. Additional test methods for machine verification
BS ISO 12787:2011 Cosmetics. Analytical methods. Validation criteria for analytical results using chromatographic techniques
BS ISO 12828-1:2011 Validation method for fire gas analysis. Limits of detection and quantification
18/30338923 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS ISO 7210:2018 Routine analytical cigarette-smoking machine. Additional test methods for machine verification
BS ISO 10705-3:2003 Water quality. Detection and enumeration of bacteriophages. Validation of methods for concentration of bacteriophages from water
21/30384564 DC BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles

International Organization for Standardization (ISO)

ISO/CD TS 12828-3:2024 Validation method for fire gas analysis
ISO/TS 22176:2020 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
ISO 12828-2:2016 Validation methods for fire gas analyses - Part 2: Intralaboratory validation of quantification methods
ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
ISO/DIS 23417:1975 General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO 7210:2013 Routine analytical cigarette-smoking machine - Additional test methods for machine verification
ISO/PRF TS 7013 Water quality — Guidance and requirements for designing an interlaboratory trial for validation of analytical methods
ISO 10705-3:2003 Water quality - Detection and enumeration of bacteriophages - Part 3: Validation of methods for concentration of bacteriophages from water
ISO/TS 7013:2023 Water quality — Guidance and requirements for designing an interlaboratory trial for validation of analytical methods
ISO/TS 12828-3:2020 Validation method for fire gas analysis — Part 3: Considerations related to interlaboratory trials

American Society for Testing and Materials (ASTM)

ASTM E2857-11 Standard Guide for Validating Analytical Methods
ASTM E2857-11(2016) Standard Guide for Validating Analytical Methods
ASTM E2857-21 Standard Guide for Validating Analytical Methods
ASTM E2857-11(2021)e1 Standard Guide for Validating Analytical Methods
ASTM E2857-22 Standard Guide for Validating Analytical Methods
ASTM E2918-23 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2918-18 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2898-20 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E2918-13 Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2918-18a Standard Test Method for Performance Validation of Thermomechanical Analyzers
ASTM E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E2898-13 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E2549-09 Standard Practice for Validation of Seized-Drug Analytical Methods

GSO

BH GSO ISO 22176:2023 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
GSO ISO 22176:2022 Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
BH GSO ISO 12828-2:2022 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
GSO ISO 12828-2:2021 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
OS GSO ISO 11737-2:2015 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BH GSO ISO 11737-2:2016 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
OS GSO ISO 12787:2013 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques
BH GSO ISO 12787:2016 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques
GSO ISO/TS 13004:2021 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
BH GSO ISO/TS 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
GSO ISO 10705-3:2013 Water quality -- Detection and enumeration of bacteriophages -- Part 3: Validation of methods for concentration of bacteriophages from water
GSO ISO/TR 24094:2013 Analysis of natural gas -- Validation methods for gaseous reference materials
GSO ISO 12787:2013 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques
GSO 1413:2002 NON-ALCOHOLIC CARBONATED BEVERAGES – METHODS OF BACTERIOLOGICAL EXAMINATION
BH GSO ISO 10705-3:2016 Water quality -- Detection and enumeration of bacteriophages -- Part 3: Validation of methods for concentration of bacteriophages from water
OS GSO ISO 10705-3:2013 Water quality -- Detection and enumeration of bacteriophages -- Part 3: Validation of methods for concentration of bacteriophages from water

Lithuanian Standards Office

LST CEN/TS 16800-2021 Guideline for the validation of physico-chemical analytical methods
LST EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

CZ-CSN

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

IT-UNI

UNI CEN/TS 16800-2021 Guideline for the validation of physico-chemical analytical methods
UNI EN ISO 11737-2:2021 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

KR-KS

KS P ISO 11737-2-2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11737-2-2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS E ISO 11726-2018 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS I ISO TR 24094-2023 Analysis of natural gas — Validation methods for gaseous reference materials
KS I ISO 10705-3-2015 Water quality — Detection and enumeration of bacteriophages — Part 3: Validation of methods for concentration of bacteriophages from water
KS I ISO 10705-3-2021 Water quality — Detection and enumeration of bacteriophages —Part 3: Validation of methods for concentration of bacteriophages from water
KS H ISO 7210-2019 Routine analytical cigarette-smoking machine — Additional test methods for machine verification

RU-GOST R

GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST 7702.2-1974 Poultry meat. Methods of bacteriological analysis
GOST 21237-1975 Meat. Methods of bacteriological analysis
GOST 25311-1982 Feeding flour of animal origin. Methods for bacteriological analysis
GOST R 8.729-2010 State system for ensuring the uniformity of measurements. Analytical gas laboratory chromatographs. Verification procedure
GOST ISO 12787-2016 Perfumery and cosmetics. Analytical methods. Validation criteria for analytical results using chromatographic techniques
GOST R ISO 11737-2-2003 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

Korean Agency for Technology and Standards (KATS)

KS P ISO 11737-2:2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11737-2:2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS I ISO 24094-2010(2016) Analysis of natural gas－Validation methods for gaseous reference materials
KS E ISO 11726-2023 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS M ISO 12787-2014(2019) Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
KS E ISO 11726:2018 Solid mineral fuels — Guidelines for the validation of alternative methods of analysis
KS I ISO 24094-2010(2021) Analysis of natural gas－Validation methods for gaseous reference materials
KS M ISO 12787:2014 Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
KS M ISO 12787-2019 Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
KS I ISO 10705-3:2015 Water quality — Detection and enumeration of bacteriophages — Part 3: Validation of methods for concentration of bacteriophages from water
KS H ISO 7210:2019 Routine analytical cigarette-smoking machine — Additional test methods for machine verification
KS I ISO 10705-3:2021 Water quality — Detection and enumeration of bacteriophages —Part 3: Validation of methods for concentration of bacteriophages from water
KS B ISO 3453-2006(2011) Non－destructive testing－Liquid penetrant inspection－Means of verification
KS I ISO 10705-3:2010 Water quality-Detection and enumeration of bacteriophages-Part 3:Validation of methods for concentration of bacteriophages from water
KS P 1011-2008 Test method of the 2-D electrophoresis for recombinant bacteria

American Society of Mechanical Engineers (ASME)

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

Japanese Industrial Standards Committee (JISC)

JIS T 11737-2:2013 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
JIS B 9927:1994 Cleanroom -- Air filters -- Test methods
JIS B 9927:1999 Cleanroom -- Air filters -- Test methods

GOST

GOST R ISO 11737-2-2022 Sterilization of health care products. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

CH-SNV

SN EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

AENOR

UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE 71506:2013 Information Technologies (IT). Methodology for the digital evidences forensic analysis
UNE-CR 13505:2003 Food analysis. Biotoxins. Criteria of analytical methods of mycotoxins.

VN-TCVN

TCVN 4584-1988 Waste water.Method for sanitary bacteriological analysis

SE-SIS

SIS SS 02 81 79-1986 Faecal streptococci in water - Enumeration with colony counting methods

IN-BIS

IS 1479 Pt.3-1977 Dairy Industry Test Methods Part III Bacteriological Analysis of Milk

DIN

DIN EN ISO 11737-2:2000 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998); English version of DIN EN ISO 11737-2
DIN 10186:2022 Microbiological analysis of milk - Enumeration of yeasts and moulds - Reference method

PL-PKN

PN-EN ISO 11737-2-2020-11 E Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
PN-ISO 10705-3-2021-01 P Water quality -- Detection and enumeration of bacteriophages -- Part 3: Validation of methods for concentration of bacteriophages from water

American Welding Society (AWS)

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WRC - Welding Research Council

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

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American National Standards Institute （ANSI)

ANSI/AAMI ST79/A 3.7-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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CU-NC

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