Determination method of sterility degree of clean room

Determination method of sterility degree of clean room, Total:197 items.

The international standard classification for "Determination method of sterility degree of clean room" includes: Food microbiology , Laboratory medicine , Other standards related to sterilization and disinfection , Workplace atmospheres , Chemical analysis , Animal husbandry and breeding , Sterilization and disinfection in general .

The Chinese standard classification for "Determination method of sterility degree of clean room" includes: Food sanitation , Medical apparatus and devices in general , Basic standards and general methods for chemical additive , Pharmaceutical in general , Basic standards and general methods for water treatment agent , Domesticate animal , Public medical equipment , General and microsurgical devices .

未注明发布机构

ASTM RR-E35-1007 2013 E2149-Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions
DIN ISO 16000-17 E:2007-02 Indoor air - Part 17: Detection and enumeration of moulds - Culture-based method
DIN EN ISO 11737-2 E:2018-07 Microbiological methods for sterilization of medical devices Part 2: Definition, effectiveness and maintenance of sterility tests during sterilization processes (draft)
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
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

Professional Standard - Commodity Inspection

SN/T 2100-2008 Commercial sterilization of canned food for rapid detection method
SN/T 3122-2012 Test method for antibacterial capability of inorganic antibacterial agents

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

GB/T 14643.6-2009 Examination of bacteria and algae in industrial circulating cooling water - Part 6: Examination of iron bacteria - MPN test
GB/T 21510-2008 Antimicrobial property detection methods for nano-inorganic materials
GB/T 19973.2-2005 Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process
GB/T 21510-2024 Antimicrobial property testing and evaluation methods for nano-inorganic materials
GB/T 16294-2010 Test method for settling microbe in clean room(zone) of the pharmaceutical industry
GB/T 16293-1996 Test method for airborne microbe in clean room(area)the pharmaceutical industry
GB/T 16294-1996 Test method for settling microbe in clean room(area)the pharmaceutical industry
GB/T 14926.41-2001 Laboratory animal-Method for examination of environment and faeces of GF animals
GB/T 16293-2010 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry

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 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process

Fujian Provincial Standard of the People's Republic of China

DB35/T 1022-2010 Method for testing the purity of edible fungi

国家食品药品监督管理局

YY/T 1479-2016 Sterility test method for membrane filters

Group Standards of the People's Republic of China

T/AHPPA 2-2023 Determination of particulate contamination for disposable blood transfusion bag— Light obscuration method
T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
T/GDSF 0003-2023 Duplex Real-time PCR Method for the Detection of Streptococcus agalactiae and Streptococcus iniae in Tilapia
T/NAIA 0243-2023 Food processing and testing clean room (area) determination method for sedimentation bacteria
T/AHPPA 1-2023 Determination of particulate contamination for disposable sterile syringe— Light obscuration method
T/NAIA 0244-2023 Food processing and testing clean room (area) Determination method of planktonic bacteria

Liaoning Provincial Standard of the People's Republic of China

DB21/T 2395-2015 PCR Method for Detection of Avirulent Gene of Magnaporthe grisea

Professional Standard - Agriculture

250药典四部-2015 3400 Biological Assay 3414 Determination of Protein Residue in Yeast Engineering Bacteria
849兽药典一部-2015 Appendix Contents 1100 Biological Inspection Method 1106 Microbial Limit Inspection of Non-sterile Products: Controlled Bacteria Inspection Method
267药典三部-2020 Microbiological examination method 1106 Microbiological limit examination of non-sterile products: control bacteria examination method
294药典三部-2020 Bioassay 3414 Determination of Protein Residue in Yeast Engineering Bacteria
814兽药典二部-2015 Appendix Contents 1100 Biological Inspection Method 1103 Microbial Limit Inspection of Non-sterile Products: Controlled Bacteria Inspection Method
243药典四部-2020 3400 Biological Assay 3414 Determination of Protein Residue in Yeast Engineering Bacteria
244药典三部-2015 Microbiological Examination Method 1106 Microbial Limit Examination of Non-sterile Products: General Principles of Control Bacteria Examination Method 85
147药典四部-2015 1100 Biological inspection method 1106 Microbial limit inspection of non-sterile products: control bacteria inspection method
134药典四部-2020 1100 Biological inspection method 1106 Microbial limit inspection of non-sterile products: control bacteria inspection method

Professional Standard - Medicine

YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices - Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization pro
YY/T 0681.8-2011 Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination

农业农村部

NY/T 2962-2016 Methods for isolation and identification of Staphylococcus aureus，coagulase-negative Staphylococcus and Streptococcus agalactiae in milk from dairy cow with mastitis

Guangdong Provincial Standard of the People's Republic of China

DB44/T 1651-2015 Detection and Identification Methods of Banana Bacterial Soft Rot

Japanese Industrial Standards Committee (JISC)

JIS B 9927:1994 Cleanroom -- Air filters -- Test methods
JIS B 9927:1999 Cleanroom -- Air filters -- Test methods
JIS B 9919:2004 Design, construction and start-up for cleanrooms
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

SCC

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/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
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)
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/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)
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
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...
CAN/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 (Adopted ISO 11737-2:2019, third edition, 2019-12)
AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
AWPA E24-21 Laboratory Method for Evaluating the Mold Resistance of Wood-based Materials: Mold Chamber Test
AWPA E24-16 Laboratory Method for Evaluating the Mold Resistance of Wood-based Materials: Mold Chamber Test
DANSK DS/ISO/TS 22456:2021 Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
DANSK DS/ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
AWPA A20-97 Standard Methods for Chlorothalonil Assay
AWPA A20-11 Standard Methods for Chlorothalonil Assay
AWPA A20-17 Standard Method for Chlorothalonil Assay
AWPA A20-03 Standard Methods for Chlorothalonil Assay
DANSK DS/CEN/TS 17804:2022 Organic, organo-mineral and inorganic fertilizers – Detection of Enterocococaceae
SN-CEN/TS 17804:2022 Organic, organo-mineral and inorganic fertilizers - Detection of Enterocococaceae
BS PD CEN/TS 17804:2022 Organic, organo-mineral and inorganic fertilizers. Detection of Enterocococaceae
AS 1807.23:1989 Cleanrooms, workstations and safety cabinets - Methods of test, Method 23: Determination of intensity of radiation from germicidal ultraviolet lamps
DANSK DS/EN ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods
DIN 58940-6 Supplement 1:1989 Medical microbiology; methods for the determination of susceptibility of pathogens (except mycobacteria) to antimicrobial agents; MICs of agents with control strains for the agar dilution method

International Organization for Standardization (ISO)

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 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
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/DIS 7581 Method for the evaluation of basic bactericidal activity of a non-porous surface
ISO 22196:2011 Measurement of antibacterial activity on plastics and other non-porous surfaces
ISO/ASTM 51940:2022 Guidance for dosimetry for sterile insects release programs
ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
ISO/TS 22456:2021 Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

GSO

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
GSO 1413:2002 NON-ALCOHOLIC CARBONATED BEVERAGES – METHODS OF BACTERIOLOGICAL EXAMINATION
OS GSO 358:1994 Sterile hypodermic syringes for single use and methods of testing
GSO ISO/TS 22456:2023 Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
BH GSO ISO/TS 22456:2023 Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
OS GSO 590:1995 MICROBIOLOGICAL METHODS OF FOOD EXAMINATION - COMMERCIAL STERILITY TEST FOR CANNED FOOD
GSO ASTM D7102:2021 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
GSO 358:1994 Sterile hypodermic syringes for single use and methods of testing
BH GSO ASTM D7102:2022 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
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

American Society for Testing and Materials (ASTM)

ASTM F51-00(2007) Standard Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
ASTM F51/F51M-00(2007)e1 Standard Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
ASTM F51-00 Standard Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
ASTM F51/F51M-00(2014)e1 Standard Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
ASTM F91-06 Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM F91-06(2011) Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM F91-70(2001)e1 Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM F91-70(1996) Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM ISO/ASTM51940-13 Standard Guide for Dosimetry for Sterile Insect Release Programs
ASTM ISO/ASTM 51940-13 Standard Guide for Dosimetry for Sterile Insect Release Programs
ASTM D4196-05(2011) Standard Test Method for Confirming the Sterility of Membrane Filters
ASTM D7102-04 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
ASTM D7102-17 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
ASTM ISO/ASTM51940-22 Standard Guidance for Dosimetry for Sterile Insect Release Programs
ASTM D7102-17(2022) Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
ASTM ISO/ASTM 51940-22 Standard Guidance for Dosimetry for Sterile Insect Release Programs
ASTM D7102-10 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
ASTM D4196-05 Standard Test Method for Confirming the Sterility of Membrane Filters
ASTM D4196-05(2019) Standard Test Method for Confirming the Sterility of Membrane Filters
ASTM E2197-11 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
ASTM ISO/ASTM 51940-04 Standard Guide for Irradiation of Insects for Sterile Release Programs
ASTM D4196-82(1998) Standard Test Method for Confirming the Sterility of Membrane Filters

KR-KS

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 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 7864-2019 Sterile hypodermic needles for single use — Requirements and test methods

Korean Agency for Technology and Standards (KATS)

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 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 TS 19930-2023 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10−6
KS P ISO 7864:2019 Sterile hypodermic needles for single use — Requirements and test methods
KS P ISO 11737-2:2012 Sterilization of medical devices－Microbiological methods－Part 2：Tests of sterility performed in the validation of a sterilization process

German Institute for Standardization

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 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 58953-6:2023-11 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 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); German version EN ISO 11737-2:2009
DIN EN ISO 7864:2016-12 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016); German version EN ISO 7864:2016
DIN 58953-6:2023-04 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).

ES-UNE

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-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

Danish Standards Foundation

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/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices

Association Francaise de Normalisation

XP S98-108*XP ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
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 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
NF X44-103:2006 Cleanrooms and associated controlled environments - Part 3 : test methods.
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF EN ISO 7864:2016 Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai
NF T72-281:2014 Methods of airborne disinfection of surfaces - Determination of bactericidal, fongicidal, yeasticidal, mycobactericidal, tuberculicidal sporicidal and virucidal activity, including bacteriophages
NF X44-110:2004 Cleanrooms and associated controlled environments - Biocontamination control - Part 1 : general principles and methods.
NF U47-106:2004 Animal health analysis methods - In-vitro determination of the susceptibility of bacterial to antimicrobial agents using the agar dilution method.
NF B51-295:1980 Particle boards - Test method for determining rot resistance (Basidiomycetes fungi)

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
GOST 34786-2021 Drinking water. Methods for determining the total number of microorganisms, coliform bacteria, Escherichia coli, Pseudomonas aeruginosa and Enterococcus

RU-GOST R

GOST 28085-2013 Medicine remedies biological for veterinary use. Method of bacteriological control of sterility
GOST 33675-2015 Animals. Laboratory Diagnostics of Brucellosis. Bacteriological methods
GOST 10444.6-1985 Canned foods. Method for determination of thermophile strictly anairobes
GOST 29184-1991 Food products. Methods for detection and quantity determination of family Enterobacteriaceae
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 30706-2000 Infant milk products. Method for determination of yeasts and moulds quantity
GOST 30425-1997 Canned foods. Method for determination of commercial sterility
GOST 10444.9-1988 Food products. Method for determination of Clostridium perfringens
GOST 31928-2013 Probiotics medicine remedies for veterinary use. Methods for determination of the probiotics microorganisms
GOST 10444.3-1985 Canned foods. Method for determination of mesophilic airobes and facultative-anairobes
GOST 10444.5-1985 Canned foods. Method for determination of thermophilic airobes and facultive anairobes
GOST R 53030-2008 Cotton fibre. Methods for determination of mould contamination
GOST 30726-2001 Food-stuffs. Methods for detection and determination of Escherichia coli
GOST R 54065-2010 Probiotics medicine remedies for animals. Methods for determination of the probiotics microorganisms

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)
SNV 24518-1937 Textiles. Determination of antibacterial activity. Bacteria Counting Method

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)

Lithuanian Standards Office

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)
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

American National Standards Institute （ANSI)

ANSI/AAMI/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
ANSI/NFPA 287-2011 Standard Test Methods for Measurement of Flammability of Materials in Cleanrooms Using a Fire Propagation Apparatus (FPA)

GOSTR

GOST 33918-2016 Perfumery and cosmetics. Microbiology. Method of determination of sterility

British Standards Institution (BSI)

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 EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination control - General principles and methods
22/30460212 DC BS EN 16615. Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical…
BS EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
BS PAS 2424:2014 Quantitative surface test for the evaluation of residual antimicrobial ( bactericidal and/or yeasticidal) efficacy of liquid chemical disinfectan ts on hard non-porous surfaces. Test method
BS 6734:2004 Antimicrobial efficacy of disinfectants for veterinary and agricultural use - Method
BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
PD ISO/TS 22456:2021 Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
BS PD ISO/TS 22456:2021 Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
22/30450670 DC BS ISO 7581. Method for the evaluation of basic bactericidal activity of a non-porous surface
BS ISO 16000-17:2008 Indoor air - Detection and enumeration of moulds - Culture-based method
BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
BS 2646-5:1993(2011) Autoclaves for sterilization in laboratories — Part 5 : Methods of test for function and performance

PL-PKN

PN P04781-13-1989 Textile dressing materials Determination of sterility
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)

IT-UNI

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

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)
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

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

PT-IPQ

NP 579-1991 Food microbiology Sterilised milk and UHT sterilised milk. Stability and sterility evaluation

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 58953-6:2023 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

RO-ASRO

STAS 11359/10-1981 NATIVE SULPHUR ORES AND CONCENTRATES Acidity determination

ZA-SANS

SANS 12353:2008 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity

CZ-CSN

CSN 49 0684-1989 Wood preservatives. Laboratory me- thod of determination of toxic values against wood destroying fungi Basi- diomycetes

Others: