Biological Sample Method Validation

Biological Sample Method Validation, Total:160 items.

The international standard classification for "Biological Sample Method Validation" includes: Biology. Botany. Zoology , Plastics in general , Radiation protection , Solid fuels , Protection against crime , Sterilizing equipment .

The Chinese standard classification for "Biological Sample Method Validation" includes: Basic standards and general methods , Hygiene, safety and labor protection , Biological agent and blood products , Basic standards and general methods for synthetic resin and plastic , Radiation protection and monitoring in general , Coal analysis methods , Basic standard and general method on forestry , Crime judging technology , Public medical equipment .

Professional Standard - Agriculture

GB/T 43731-2024 General requirements for the validation and verification of processing methods for biological material in biobanks
343药典四部-2020 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
GB 4789.45-2023 National food safety standard - General rules for verification of microbial test methods
358药典四部-2020 9000 Guidelines 9401 Guidelines for the Validation of Bioactivity/Potency Determination Methods for Biological Products
289药典三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
1837药典一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products
324药典四部-2015 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
362药典三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
313药典四部-2015 9000 Guidelines 9012 Guidelines for Validation of Quantitative Analysis Methods of Biological Samples
328药典四部-2020 9000 Guidelines 9012 Guidelines for Validation of Quantitative Analysis Methods of Biological Samples
364药典三部-2020 Guiding Principle 9401 Guiding Principles for Validation of Bioactivity/Potency Assay Methods for Biological Products
2421药典二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs

Professional Standard - Ocean

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

Professional Standard - Hygiene

WS/T 68-1996 Biological materials―Methods of monitoring―Guide of development

Guangxi Provincial Standard of the People's Republic of China

DB45/T 2319-2021 Tritium Analysis Method in Biological Samples

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 37865-2019 Analysis method of 14C in biological samples—Oxgen bomb combustion method
GB/T 38787-2020 Plastics—Methods for the preparation of samples for biodegradation testing of plastic materials

未注明发布机构

AMPP TM21465-2024 Molecular Microbiological Methods—Sample Handling and Laboratory Processing
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 16140-4 E:2018-02 Validation of methods in food chain microbiology Part 4: Protocol for method validation in individual laboratories (draft)
DIN EN ISO 16140-1 E:2013-01 Validation of microbiological methods in the food chain Part 1: Glossary (draft)

Professional Standard - Nuclear Industry

EJ 194.3-1982 Environmental samples.Method for analyzing total trace of mercury in biological samples

Professional Standard - Commodity Inspection

SN/T 2552.1-2010 Microbiological Examination Method for Milk and Milk Products Hygiene - Part 1: Guidance on Sampling
SN/T 2552.2-2010 Microbiological Examination Method for Milk and Milk Products Hygiene - Part 2: Preparation of Test Samples|| Initial Suspensions and Decimal Dilutions

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

GB/T 28730-2012 Method for preparation of solid biofuels sample

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 35814-2018 Method for analysis of forestry biomass―Preparation of samples

Professional Standard - Public Safety Standards

GA/T 930-2011 GC and chemistry examination methods for cyanogens ion in biology samples

国家市场监督管理总局

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

国家食品药品监督管理局

YY/T 1495-2016 Microbiological test method for demonstrating cleaning and disinfecting efficacy

Association Francaise de Normalisation

NF ISO 21899:2020 Biotechnology - Biobanks - General requirements for validation and verification of methods for processing biological material in biobanks
NF X42-150*NF ISO 21899:2020 Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks
NF V08-103-1*NF EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1 : vocabulary
NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: protocol for method validation in a single laboratory
NF V08-103-4*NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
NF V08-103-5*NF EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
NF EN ISO 16140-6:2019 Microbiology of the food chain - Validation of methods - Part 6: protocol for the validation of alternative (commercial) methods for microbiological confirmation and typing
NF EN ISO 10210:2017 Plastics - Sample preparation methods for biodegradation testing of plastic materials
NF T51-809*NF EN ISO 10210:2017 Plastics - Methods for the preparation of samples for biodegradation testing of plastic materials
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 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 16140-1:2016 Microbiology of the food chain - Validation of methods - Part 1: vocabulary

SCC

DANSK DS/ISO 21899:2020 Biotechnology – Biobanking – General requirements for the validation and verification of processing methods for biological material in biobanks
AS 1766.4:1987 Methods for the microbiological examination of food, Part 4: Sampling of foods
BS EN ISO 16140:2003 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
DANSK DS/EN ISO 16140/A1:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
DANSK DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods
UNE-CEN/TS 14779:2007 EX Solid biofuels - Sampling - Methods for preparing sampling plans and sampling certificates
SN-CEN/TS 14779:2005 Solid biofuels — Sampling — Methods for preparing sampling plans and sampling certificates
DIN CEN/TS 14779:2005 Solid biofuels - Sampling - Methods for preparing sampling plans and sampling certificates; German version CEN/TS 14779:2005
DANSK DS/ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory
DIN CEN/TS 14780:2005 Solid biofuels - Methods for sample preparation; German version CEN/TS 14780:2005
SN-CEN/TS 14780:2005 Solid biofuels — Methods for sample preparation
UNE-CEN/TS 14780:2008 EX Solid biofuels - Methods for sample preparation
DANSK DS/CEN/TS 14780:2005 Solid biofuels - Methods for sample preparation
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
NACE AMPP TM21465-2024 Molecular Microbiological Methods— Sample Handling and Laboratory Processing
DANSK DS/ISO 16140-3:2021 Microbiology of the food chain â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
NS-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
UNE-EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
DANSK DS/ISO 16140-6:2019 Microbiology of the food chain – Method validation – Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
DANSK DS/EN ISO 16140-4:2020 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
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)
AENOR UNE-EN ISO 16140/A1:2003 Microbiology of the foods for animal and human use. Alternative methods validation protocol (ISO 16140:2003).
AENOR UNE-EN ISO 16140:2003 Microbiology of the foods for animal and human use. Alternative methods validation protocol (ISO 16140:2003).
DIN EN ISO 16140-2 E:2013 Draft Document - Microbiology of food and animal feed - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO/DIS 16140-2:2012); German version prEN ISO 16140-2:2012
BS ISO 10836:1994 Iron ores. Method of sampling and sample preparation for physical testing

British Standards Institution (BSI)

BS ISO 21899:2020 Biotechnology. Biobanking. General requirements for the validation and verification of processing methods for biological material in biobanks
19/30364961 DC BS ISO 21899. Biotechnology. Biobanking. General requirements for the validation and verification of processing methods for biological material in biobanks
BS EN ISO 16140-1:2016 Microbiology of the food chain. Method validation. Vocabulary
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 16140-3:2021 Microbiology of the food chain. Method validation. Protocol for the verification of reference methods and validated alternative methods in a single laboratory
BS EN ISO 16140-2:2016 Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods against a reference method
DD CEN/TS 14779:2005 Solid biofuels. Sampling. Methods for preparing sampling plans and sampling certificates
BS DD CEN/TS 14779:2005 Solid biofuels — Sampling — Methods for preparing sampling plans and sampling certificates
BS DD CEN/TS 14779:2006 Solid biofuels. Sampling. Methods for preparing sampling plans and sampling certificates
BS DD CEN/TS 14780:2005 Solid biofuels — Methods for sample preparation
BS DD CEN/TS 14780:2006 Solid biofuels. Methods for sample preparation
BS EN ISO 16140-4:2020 Microbiology of the food chain. Method validation - Protocol for method validation in a single laboratory
BS EN ISO 16140-5:2020 Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods
BS EN ISO 16140-6:2019 Microbiology of the food chain. Method validation - Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
BS EN ISO 10210:2017 Plastics. Methods for the preparation of samples for biodegradation testing of plastic materials

IT-UNI

UNI ISO 21899:2021 Biotechnology -- Biobanking -- General requirements for the validation and verification of processing methods for biological material in biobanks

VN-TCVN

TCVN 5666-1992 Biological substances.Methods for sampling and storaging of samples
TCVN 5119-1990 Packages.Methods of sample preparation for determination of microorganisms

International Organization for Standardization (ISO)

ISO/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
ISO 16140-4:2020 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation 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 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 16140-4:2020/CD Amd 2 Microbiology of the food chain-Method validation-Part 4: Protocol for method validation in a single laboratory
ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
ISO 16140-5:2020 Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
ISO 21899:2020 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
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 16140-2:2016 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 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 5667-16:1998 Water quality - Sampling - Part 16: Guidance on biotesting of samples

RU-GOST R

GOST R 57233-2016 Microbiological products. Acceptance regulations and methods of sampling
GOST 28495-1990 Microbiological products. Acceptance regulations and methods of sampling
GOST 31904-2012 Food products. Methods of sampling for microbiological analyses
GOST R 54004-2010 Food products. Methods of sampling for microbiological analyses
GOST R 54187-2010 Solid biofuels. Sampling. General requirements
GOST R 54187-2010(2019) Solid biofuels. Sampling. General requirements
GOST 33255-2015 Solid biofuels. Methods for sample preparation
GOST R 54212-2010 Solid biofuels. Methods for sample preparation
GOST ISO 16140-2011 Microbiology of food and animal feeding stuffs. Protocol for the validation of alternative methods
GOST R 51448-1999 Meat and meat products. Methods of test samples preparation for microbiological examination

European Committee for Standardization (CEN)

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 16140-3:2021 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)
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 16140-5:2020 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
EN ISO 16140-2:2016 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 5667-16:2017 Water quality - Sampling - Part 16: Guidance on biotesting of samples

GSO

OS GSO 261:1994 MICROBIOLOGICAL METHODS OF FOOD EXAMINATION – PART 1: PREPARATION OF SAMPLES
OS GSO ISO 16140:2014 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
BH GSO ISO 16140:2016 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
GSO ISO 7373:2013 Ferroalloys -- Experimental methods for checking the precision of sample division
GSO ISO 16140-2:2021 Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
BH GSO ISO 16140-2:2022 Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
GSO 261:1994 MICROBIOLOGICAL METHODS OF FOOD EXAMINATION – PART 1: PREPARATION OF SAMPLES
BH GSO ISO 16140-1:2022 Microbiology of the food chain — Method validation — Part 1: Vocabulary

KR-KS

KS J ISO 21899-2023 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks

Korean Agency for Technology and Standards (KATS)

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 I ISO 5667-16:2009 Water quality－Sampling－Part 16：Guidance on biotesting of samples

CEN - European Committee for Standardization

PD CEN/TS 14779:2005 Solid biofuels - Sampling - Methods for preparing sampling plans and sampling certificates
ENV ISO 13843:2001 Water Quality - Guidance on Validation of Microbiological Methods
PD CEN/TS 14780:2005 Solid biofuels - Methods for sample preparation

German Institute for Standardization

DIN EN ISO 16140-7:2023-05 Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023); German and English version prEN ISO 16140-7:2023 / Note: Date of issue 2023-04-21
DIN EN ISO 16140-4:2020-12 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020); German version EN ISO 16140-4:2020
DIN EN ISO 16140-6:2020-04 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019); German version EN ISO 16140-6:2019
DIN EN ISO 16140-3:2021-06 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021); German version EN ISO 16140-3:2021
DIN EN ISO 16140-5:2020-12 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020); German version EN ISO 16140-5:2020
DIN EN ISO 16140-2:2016-11 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

Danish Standards Foundation

DS/ENV ISO/TR 13843:2001 Water quality - Guidance on validation of microbiological methods
DS/EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
DS/ISO 16140-3:2021 Microbiology of the food chain â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
DS/EN ISO 16140-3:2021 Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

ES-UNE

UNE-EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
UNE-EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
UNE-EN ISO 16140-6:2020 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
UNE-EN ISO 16140-5:2021 Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
UNE-EN ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)
UNE-EN ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)

Indonesia Standards

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

CZ-CSN

CSN 56 0080-1983 Food products. SampUng ethods for mlcrobiological xamination

TH-TISI

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

PL-PKN

PN A78511-1973 Mushroom products Sampling, preparation of samples and method of microbiological analyses
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)

Standard Association of Australia （SAA）

AS 5013.20:2017 Food microbiology, Method 20: Preparation of test samples for microbiological examination — Poultry and poultry product surfaces

AT-ON

OENORM EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

DIN

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

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

CH-SNV

SN EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

Japanese Industrial Standards Committee (JISC)

JIS K 3836:1995 Testing methods for collection efficiency of airborne microbe samplers

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