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Sterilization product testing

Sterilization product testing, Total:498 items.

In the international standard classification, Sterilization product testing involves: Sterilization and disinfection, Nuclear energy engineering, Microbiology, Meat, meat products and other animal produce, General methods of tests and analysis for food products, Fruits. Vegetables, Milk and milk products, Medical equipment, Biology. Botany. Zoology, Food products in general, Radiation measurements, Vocabularies, Protection against fire, Animal feeding stuffs, Space systems and operations, Products of the textile industry, Farming and forestry, Products of the chemical industry.

International Organization for Standardization (ISO), Sterilization product testing

• ISO/TS 13409:2002 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
• ISO/TR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
• ISO/TR 13409:1996 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
• ISO/TS 15843:2000 Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
• ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
• ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
• ISO/FDIS 11737-3 Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
• ISO 11737-3:2023 Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
• ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
• ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
• ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
• ISO 13408-2:2018 Aseptic processing of health care products — Part 2: Sterilizing filtration
• ISO 11137:1995/Amd 1:2001 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Amendment 1: Selection of terms for dose setting
• ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>
• ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• ISO 11138-3:1995 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization
• ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
• ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization
• ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO 14161:2000 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• 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 11137-2:2006/Cor 1:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
• ISO 11737-1:2018/Amd 1:2021 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
• ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO/TS 11137-4:2020 Sterilization of health care products — Radiation — Part 4: Guidance on process control
• ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General
• ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• 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
• ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• ISO 11139:2018/DAmd 1 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definition
• ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
• ISO 11137-1:2006/Amd 1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1
• ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1
• ISO/TS 22964:2006 Milk and milk products - Detection of Enterobacter sakazakii
• ISO/TS 22964:2006|IDF/RM 210:2006 Detection of Enterobacteriaceae in Milk and Dairy Products
• ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
• ISO 11140-6:2022 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
• ISO 6785:2001|IDF 93:2001 Milk and milk products — Detection of Salmonella spp.
• ISO 6785:1985 Milk and milk products — Detection of salmonella
• ISO 6785:2001 | IDF 93:2001 Milk and milk products — Detection of Salmonella spp.
• ISO/TS 22964:2006 | IDF/RM 210: 2006 Milk and milk products — Detection of Enterobacter sakazakii
• ISO 11140-2:1998 Sterilization of health care products - Chemical indicators - Part 2: Test equipment and methods
• ISO 20743:2007 Textiles - Determination of antibacterial activity of antibacterial finished products
• ISO 11737-1:2006/Cor 1:2007 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products; Technical Corrigendum 1
• ISO 6579:2002/Amd 1:2007 Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp.; Amendment 1: Annex D: Detection of Salmonella spp. in animal faeces and in samples from the primary production stage

IN-BIS, Sterilization product testing

• IS 10150-1981

Association Francaise de Normalisation, Sterilization product testing

• NF EN ISO 18472:2018 Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage d'essai
• XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
• XP ISO/TS 22421:2021 Stérilisation des produits de santé - Exigences communes applicables aux stérilisateurs utilisés pour la stérilisation terminale des dispositifs médicaux dans les établissements de santé
• NF S98-001-4*NF EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4 : class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration.
• NF S98-103-2:2013 Sterilization of health care products - Radiation - Part 2: establishing the sterilization dose
• NF S98-103-2*NF EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose
• NF S98-004-3:2006 Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes.
• NF EN ISO 14937:2009 Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
• NF S98-004-2:2006 Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes.
• NF S98-004-4:2006 Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes.
• NF L90-200-70-53*NF EN 16602-70-53:2016 Space product assurance - Materials and hardware compatibility tests for sterilization processes
• NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
• NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
• NF S98-100:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results.
• NF EN ISO 11737-2:2020 Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2 : contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation
• NF EN ISO 11737-1:2018 Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1 : détermination d'une population de micro-organismes sur des produits
• 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 EN ISO 11137-1:2016 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
• NF EN ISO 11135:2014 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux
• NF S98-118-1*NF EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products
• NF EN 16602-70-53:2016 Assurance produit des projets spatiaux - Essais de compatibilité des matériaux et matériels pour les processus de stérilisation
• NF S98-101-1:2007 Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.
• NF S98-103-1/A1:2013 Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
• NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
• NF CEN ISO/TS 17665-2:2009 Stérilisation des produits de santé - Chaleur humide - Partie 2 : directives relatives à l'application de l'ISO 17665-1
• NF S98-004-5:2006 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
• NF EN ISO 11737-1/A1:2021 Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1 : détermination d'une population de microorganismes sur des produits - Amendement 1
• NF S98-004-1:2006 Sterilization of health care products - Biological indicators - Part 1 : general requirements.
• NF S98-118-1/A1*NF EN ISO 11737-1/A1:2021 Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products - Amendment 1
• NF S98-118-1:2006 Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products.
• NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
• NF EN ISO 11137-1/A2:2019 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux - Amendement 2 : révision de 4.3.4 e...
• NF EN ISO 11140-4:2007 Stérilisation des produits de santé - Indicateurs chimiques - Partie 4 : indicateurs de classe 2 comme alternative à l'essai de Bowie et Dick pour la détection de la pénétration de la vapeur
• NF EN ISO 20743:2021 Textiles - Détermination de l'activité antibactérienne des produits textiles
• NF V08-013/A1:2007 Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp. - Amendment 1 : annex D : detection of Salmonella spp. in animal faeces and in samples from the primary production stage.
• NF T75-604*NF EN ISO 21150:2016 Cosmetics - Microbiology - Detection of Escherichia coli
• NF EN ISO 21150:2016 Cosmétiques - Microbiologie - Détection d'Escherichia coli

British Standards Institution (BSI), Sterilization product testing

• BS ISO 11737-3:2023 Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing
• BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
• BS EN ISO 11137-2:2012 Sterilization of health care Products. Radiation. Establishing the sterilization dose
• BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose
• BS EN ISO 11137-2:2013 Sterilization of health care products. Radiation. Establishing the sterilization dose
• BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation. Establishing the sterilization dose
• BS EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes
• BS EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
• BS EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
• BS EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
• BS EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
• BS EN ISO 11138-3:2017 Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
• BS EN ISO 11138-2:2017 Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
• BS EN ISO 11737-1:2018 Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
• BS EN ISO 11737-1:2018+A1:2021 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
• 22/30386830 DC BS ISO 11737-3. Sterilization of health care products. Microbiological methods - Part 3. Bacterial endotoxin testing
• BS EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes
• BS EN ISO 11138-8:2021 Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
• BS EN ISO 11137-3:2007 Sterilization of health care products - Radiation - Guidance on dosimetric aspects
• PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization
• BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
• BS EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - General requirements
• BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
• 22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for 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 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
• BS EN ISO 14161:2010 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
• BS EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• 23/30424625 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
• 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
• 21/30431923 DC BS ISO 13004. Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VD_max^SD
• 21/30412844 DC BS EN ISO 22441. Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
• BS PD ISO/TS 13004:2013 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
• BS PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
• 19/30383528 DC BS EN ISO 11737-1 AMD1. Sterilization of health care products. Microbiological methods. Part 1. Determination of a population of microorganisms on products
• BS EN ISO 6785:2007 Milk and milk products. Detection of Salmonella spp.
• BS EN ISO 18472:2018 Tracked Changes. Sterilization of health care products. Biological and chemical indicators. Test equipment
• BS EN ISO 21150:2015+A1:2022 Cosmetics. Microbiology. Detection of Escherichia coli
• BS EN ISO 11140-6:2022 Tracked Changes. Sterilization of health care products. Chemical indicators. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
• BS EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

German Institute for Standardization, Sterilization product testing

• DIN 58950-3:2021-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English / Note: DIN 58950-3 (2011-01) remains valid alongside this standard until 2022-06-01.
• 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 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007);German version EN ISO 11140-4:2007
• DIN EN ISO 14160:2018 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• DIN EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006); English version of DIN EN ISO 11138-4:2006-09
• DIN EN 16602-70-53:2015-05 Space product assurance - Materials and hardware compatibility tests for sterilization processes; English version EN 16602-70-53:2015
• DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
• DIN EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006); German version EN ISO 11138-3:2006
• DIN 51441:2007-04 Testing of mineral products - Determination of the microbial colony number in petroleum products with a boiling range below 400 °C
• DIN EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-2:2006
• DIN EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006
• DIN EN ISO 11137-1:2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
• DIN EN ISO 18472:2018-11 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018); German version EN ISO 18472:2018
• DIN EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) English version of DIN EN ISO 11137-3:2006-07
• DIN EN ISO 11737-1:2021-10 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
• DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
• DIN EN ISO 11137-1:2023-05 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 / Note:...
• DIN EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); English version of DIN EN ISO 11138-1:2006-09
• DIN EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
• DIN EN ISO 14160:2021-11 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization...
• 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 EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); English version of DIN EN ISO 11137-2:2007-09
• DIN EN ISO 11139/A1:2023 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 (ISO 11139:2018/DAM 1:2023); German and English version EN ISO 11139:2018/prA1:2023
• DIN EN ISO 11138-5 Berichtigung 1:2007 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-
• DIN EN 16602-70-53:2015 Space product assurance - Materials and hardware compatibility tests for sterilization processes; English version EN 16602-70-53:2015
• DIN EN ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007); German version EN ISO 11140-3:2007
• DIN EN ISO 11140-6:2023-02 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO 11140-6:2022); German version EN ISO 11140-6:2022
• DIN EN ISO 11137-3:2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017
• DIN EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012
• DIN EN ISO 21150:2023-01 Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015 + Amd 1:2022); German version EN ISO 21150:2015 + A1:2022
• DIN EN ISO 6785:2007 Milk and milk products - Detection of Salmonella spp. (ISO 6785:2001); English version of DIN EN ISO 6785:2007-09
• DIN EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); English version of DIN EN ISO 11138-2:2009-09

Korean Agency for Technology and Standards (KATS), Sterilization product testing

• KS P ISO 11137-2:2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
• KS P ISO 18472:2020 Sterilization of health care products — Biological and chemical indicators — Test equipment
• KS P ISO 11138-3:2018 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
• KS P ISO 11737-1:2021 Sterilization of health care products — Microbiological methods —Part 1: Determination of a population of microorganisms on products
• KS P ISO 11138-3:2012 Sterilization of health care products-Biological indicators-Part 3:Biological indicators for moist heat sterilization processes
• KS P ISO 11138-2:2012 Sterilization of health care products－Biological indicators－Part 2：Biological indicators for ethylene oxide sterilization processes
• KS P ISO 11138-2:2018 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
• KS P ISO 14937:2018 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devi
• KS P ISO 14161:2012 Sterilization of health care products－Biological indicators－Guidance for the selection, use and interpretation of results
• KS P ISO 11138-5:2009 Sterilization of health care products－Biological indicators－Part 5：Biological indicators for low-temperature steam and formaldehyde sterilization processes
• KS P ISO 11138-5:2020 Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• 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 11140-4:2020 Sterilization of health care products — Chemical indicators —Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
• 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 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11140-1:2018 Sterilization of health care products — Chemical indicators — Part 1: General requirements
• KS J 4206-2008 Testing methods for antibacterial activity of antibacterial functional products-Part 1:Shake flask method
• KS P ISO 11138-1:2018 Sterilization of health care products — Biological indicators — Part 1: General requirements
• KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11737-1:2018 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
• KS P ISO 11140-1:2012 Sterilization of health care products－Chemical indicators－Part 1：General requirements
• KS P ISO 14161:2018 Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
• KS M ISO 21150:2019 Cosmetics — Microbiology — Detection of Escherichia coli

KR-KS, Sterilization product testing

• KS P ISO 11137-2-2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
• KS P ISO 18472-2020 Sterilization of health care products — Biological and chemical indicators — Test equipment
• KS P ISO 11138-3-2018 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
• KS P ISO 11737-1-2021 Sterilization of health care products — Microbiological methods —Part 1: Determination of a population of microorganisms on products
• KS P ISO 11737-1-2022 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
• KS P ISO 11138-2-2018 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
• KS P ISO 14937-2018 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devi
• KS P ISO 11138-5-2020 Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• 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 11140-4-2020 Sterilization of health care products — Chemical indicators —Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
• 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 11137-1-2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• KS P ISO 17665-1-2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11140-1-2018 Sterilization of health care products — Chemical indicators — Part 1: General requirements
• KS P ISO 11138-1-2018 Sterilization of health care products — Biological indicators — Part 1: General requirements
• KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
• KS P ISO 11737-1-2018 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
• KS P ISO 14161-2018 Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
• KS M ISO 21150-2019 Cosmetics — Microbiology — Detection of Escherichia coli

Professional Standard - Agriculture, Sterilization product testing

• JAP-108 Cyromazine detection method (agricultural products)
• JAP-109 Cyromazine detection method (animal product)
• JAP-101 Method for detection of imidazolidin (animal product)
• JAP-042 Detection method of boscalid (agricultural products)
• JAP-043 Boscalid detection method (animal product)
• JAP-082 Captan, ethyl ester fofol, chlorothalonil and folpet detection method
• NY/T 550-2002 Defection methods of salmonella for animal and animal products
• NY/T 555-2002 Detection methods for coliform group,faecal coliform group,coliform bacteria in animal products
• 134药典 四部-2020 1100 Biological inspection method 1106 Microbial limit inspection of non-sterile products: control bacteria inspection method
• 267药典 三部-2020 Microbiological examination method 1106 Microbiological limit examination of non-sterile products: control bacteria examination method
• 147药典 四部-2015 1100 Biological inspection method 1106 Microbial limit inspection of non-sterile products: control bacteria inspection method
• COFCC有机认证产品风险检测项目目录
• 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
• GB 4789.13-1994 Food Hygiene Microbiology Test Clostridium Perfringens Test
• 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
• 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
• SN/T 5514-2023
• 440兽药质量标准2017年版 Chemical Drugs Volume 2 Veterinary Drug Product Instructions Template Five-Picture Sterilization Crystal Sulfonamide Instructions
• 水产品质量安全检验手册 3.2.1.0-2005 Chapter 3 Inspection of microorganisms in aquatic products Section 2 Inspection of coliforms, fecal coliforms and Escherichia coli 1. Inspection of coliforms and fecal coliforms (GBT 4789.3-2003)
• SN/T 5090.1-2018 Commercial Kit Detection Method Mold and Yeast Method 1
• SN/T 5090.2-2018 Commercial kit detection method mold and yeast method two

US-AAMI, Sterilization product testing

• ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
• AAMI TIR52-2014 Environmental monitoring for terminally sterilized healthcare products
• ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose
• ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterilization product testing

• GB/T 19971-2015 Sterilization of health care products.Vocabulary
• GB 18280.2-2015 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
• GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
• GB/T 31995-2015 Sterilization of health care products.Radiation.Substantiation of a selected sterilization dose method VD<下标max>
• GB/T 19971-2005 Sterilization of health care products.Vocabulary
• GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
• GB 18281.3-2000 Sterilization of health care products--Biological indicators--Part 3: Biological indicators for moist heat sterilization
• GB 18281.4-2015 Biological indicators for sterilization of healthcare products - Part 4: Biological indicators for dry heat sterilization
• GB 18281.3-2015 Biological indicators for sterilization of healthcare products - Part 3: Biological indicators for moist heat sterilization
• GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities
• GB/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects
• GB/T 24628-2009 Sterilization of health care products.Biological and chemical indicators.Test equipment
• GB/T 19974-2005 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
• GB/T 19974-2018 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
• GB 18281.2-2000 Sterilization of health care products--Biological indicators--Part 2: Biological indicators for ethylene oxide sterilization
• GB 18281.2-2015 Biological indicators for sterilization of healthcare products - Part 2: Biological indicators for ethylene oxide sterilization
• GB/T 19972-2005 Sterilization of health care products.Biological indicators.Guidance for the selection, use and interpretation of results
• GB 18281.5-2015 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam
• GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
• GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
• GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
• GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1: General requirements
• GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General
• GB 18282.1-2015 Chemical indicators for sterilization of healthcare products - part 1: general rules
• GB 18281.1-2015 Sterilization of health care products.Biological indicators.Part 1:General requirements
• GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
• GB/T 19973.1-2023 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products
• GB/T 4789.13-2003 Microbiological examination of food hygiene Examination of Clostridium perfring
• GB/T 26425-2010 Method for determination of Clostridium perfringens in feeds
• GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
• GB/T 18279.2-2015 Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1
• GB/T 32310-2015 Sterilization of health care products.Chemical indicators.Guidance for selection,use and interpretion of results
• GB 4789.13-2012 National Food Safety Standard Microbiological Examination of Food Hygiene - Examination of Clostridium Perfringens

Group Standards of the People's Republic of China, Sterilization product testing

• T/CQAP 3001-2020 Requirements for parameter release of sterile products sterilized by moist heat
• T/CASME 325-2023 Testing method for performance of moist heat sterilizer
• T/CIRA 2-2020 Guidance on radiation sterilization of tissue-based biologics and tissue-derived products
• T/WSJD 11-2020 Guidelines for performance testing and evaluation of medical sterilizers in medical and health institutions
• T/FDSA 003-2019 Test method of the process challenge device（PCD）during low-temperature plasma of hydrogen peroxide
• T/SDAA 0046-2021 Detection of Clostridium perfringens in animal feces

Taiwan Provincial Standard of the People's Republic of China, Sterilization product testing

• CNS 14709-2002 Sterilization of health care products-requirements for validation and routine control-radiation sterliization
• CNS 14621-2002 Sterilization of health care products-requirements for validation and routine control-industrial moist heat sterilization
• CNS 14622-3-2002 Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization
• CNS 14622.3-2002 Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization
• CNS 14622-2-2002 Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization
• CNS 14622.2-2002 Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization
• CNS 14622-1-2002 Sterilization of health care products-biological indicators-part 1：General
• CNS 14622.1-2002 Sterilization of health care products-biological indicators-part 1：General
• CNS 14623.2-2002 Sterilization of health care products-chemical indicators-Part 2：Test equipment and methods
• CNS 14623-2-2002 Sterilization of health care products-chemical indicators-Part 2：Test equipment and methods
• CNS 13759-1996 Method of Test for Pesticide Residues in Foods-Test of Metalaxyl,an Acylalanine Fungicide
• CNS 14623.1-2002 Sterilization of health care products-chemical indicators-Part 1：General requirements
• CNS 14623-1-2002 Sterilization of health care products-chemical indicators-Part 1：General requirements

GOSTR, Sterilization product testing

• GOST 30392-1995 Medical products. Dosimetric techniques for radiation sterilization
• GOST 32010-2013 Food products. Method for detection of Shigella species bacteria
• GOST R 58163-2018 Sterilization of health care products. Moist heat. Part 3. Guidance on the designation of a medical device to a product family and processing category for steam sterilization
• GOST 34422-2018 Sterilized meat canned products for nutrition of children over three years of age. General specifications
• GOST 7702.2.3-1993 Poultry meat, edible offal, ready-to-cook products. Method for detection of Salmonellae
• GOST 7702.2.2-1993 Poultry meat, edible offal, ready-to-cook products. Methods for detection and quantity determination of coliform bacteria (Escherichia, Citrobacter, Enterobacter, Klebsiella, Serratia)
• GOST ISO/TS 22964-2013 Milk and milk products. Detection of Enterobacter sakazakii

Danish Standards Foundation, Sterilization product testing

• DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
• DS/EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• DS/EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• DS/ISO 14160:2021 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization pr
• DS/EN ISO 14160:2021 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization pr
• 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
• DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• DS/EN ISO 11737-1/AC:2009 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
• DS/EN ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
• DS/EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• DS/EN ISO 21150:2009 Cosmetics - Microbiology - Detection of Escherichia coli

VN-TCVN, Sterilization product testing

• TCVN 7393-2-2009 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
• TCVN 7393-3-2009 Sterilization of health care products.Radiation.Part 3: Guidance on dosimetric aspects.
• TCVN 4829-2005/SD 1-2008 Microbiology of food and animal feeding stuffs.Horizontal method for the detection of Salmonella spp.Amendment 1: Annex D: Detection of Salmonella spp-in animal faeces and in environmental samples from the primary production stage
• TCVN 7850-2008 Milk and milk products.Detection of Enterobacter sakazakii

American National Standards Institute （ANSI), Sterilization product testing

• ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
• ANSI/AAMI ST25-1987 Guideline for Industrial Moist Heat Sterilization of Medical Products
• ANSI/AAMI TIR52:2014(R2022) Environmental monitoring for terminally sterilized healthcare products
• ANSI/AAMI ST67-2011 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
• ANSI/AAMI/ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• ANSI/AAMI/ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• ANSI/AAMI/ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
• ANSI/AAMI/ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• ANSI/AAMI/ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• ANSI/AAMI/ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ANSI/AAMI/ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements

RU-GOST R, Sterilization product testing

• GOST R 50325-2011 Medical products. Radiation sterilization. Dosimetric techniques
• GOST R 50106-1992 Sterilized and pasterized fish and seaproducts. Packing and marking
• GOST 33163-2014 Juice products. Detection of Alicyclobacillus bacteria species
• GOST 30519-1997 Food products. Method for detection of Salmonella
• GOST R 50480-1993 Food products. Method for detection of Salmonella
• GOST ISO 11137-2-2011 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
• GOST 3623-1973 Milk and milk products. Methods for determination of pasteurization
• GOST ISO 11138-3-2012 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
• GOST 3623-2015 Milk and milk products. Methods for determination of pasteurization
• GOST ISO 11138-2-2012 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
• GOST R ISO 11134-2000 Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization
• GOST R 50474-1993 Food products. Methods for detection and quantity determination of coliformes
• GOST 30518-1997 Food products. Methods for detection and quantity determination of coliformes
• GOST 8.651-2016 State system for ensuring the uniformity of measurements. Medical products. Radiation sterilization. Dosimetric techniques
• GOST ISO 11140-1-2011 Sterilization of health care products. Chemical indicators. Part 1. General requirements
• GOST R ISO 11138-3-2000 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
• GOST 10444.2-1994 Food products. Methods for detection and quantity determination of Staphylococcus aureus
• GOST R 50396.3-1992 Poultry meat, edible offal, ready-to-cook products. Method for detection of Salmonellae
• GOST R 50396.2-1992 Poultry meat, edible offal, ready-to-cook products. Methods for detection and quantity determination of coliform bacteria (Escherichia, Citrobacter, Enterobacter, Klebsiella, Serratra)
• GOST 31659-2012 Food products. Methods for the detection of Salmonella spp
• GOST ISO 11138-1-2012 Sterilization of health care products. Biological indicators. Part 1. Technical requirements
• GOST R ISO 13683-2000 Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities
• GOST R 52814-2007 Food products. Method for the detection of Salmonella
• GOST 30726-2001 Food-stuffs. Methods for detection and determination of Escherichia coli
• GOST 29184-1991 Food products. Methods for detection and quantity determination of family Enterobacteriaceae
• GOST R ISO 11138-2-2000 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
• GOST ISO 11140-2-2011 Sterilization of health care products. Chemical indicators. Part 2. Test equipment and methods
• GOST R 54085-2010 Food products. Method for detection of Shigella species bacteria
• GOST 10444.7-1986 Food products. Methods of detection of botulinum toxins and Clostridium botulinum
• GOST 28566-1990 Food products. Method for detection and determination of count Enterococci
• GOST R 52816-2007 Food products. Methods for detection and quantity determination of coliformes
• GOST ISO 11737-1-2012 Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products
• GOST R ISO 11737-1-2000 Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products

European Committee for Standardization (CEN), Sterilization product testing

• EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development@ validation and routine control
• EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration
• EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• EN ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
• EN ISO 11137-2:2015/prA1:2021 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
• EN ISO 11137-2:2015/A1:2023 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
• EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• EN ISO 14161:2000 Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results ISO 14161:2000
• EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• EN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
• EN 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
• EN 1174-2:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 2: Guidance
• EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• prEN ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
• EN ISO 11140-6:2022 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
• EN ISO 11137-1:2006/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)
• EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
• EN ISO 6785:2007 Milk and milk products - Detection of Salmonella spp. (ISO 6785:2001)
• EN ISO/TS 13004:2014 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
• EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

HU-MSZT, Sterilization product testing

• MSZ 3643-1959 2.lap
• MSZ 3620/1-1972
• MSZ 3612/4.lap-1961
• MSZ 11728-1963
• MSZ 3640/8-1980
• MSZ 20546/10-1979
• MSZ 20546/8-1979
• MSZ 6270-1968
• MNOSZ 19010-1954
• MSZ 5383-1971

ES-UNE, Sterilization product testing

• 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 ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
• UNE-EN 16602-70-53:2015 Space product assurance - Materials and hardware compatibility tests for sterilization processes (Endorsed by AENOR in March of 2015.)
• UNE-EN ISO 11737-1:2018/A1:2022 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
• UNE-EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
• UNE-EN ISO 18472:2020 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
• UNE-EN ISO 25424:2020/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
• UNE-EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization...
• UNE-EN ISO 11137-1:2015/A2:2020 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
• UNE-EN ISO 20743:2022 Textiles - Determination of antibacterial activity of textile products (ISO 20743:2021)
• UNE-EN ISO 11137-3:2018 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
• UNE-EN ISO 21150:2016 Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)
• UNE-EN ISO 11135:2015/A1:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

未注明发布机构, Sterilization product testing

• BS 3970-6:1993(1999) Sterilizing and disinfecting equipment for medical products — Part 6 : Specification for sterilizers using low temperature steam with formaldehyde
• BS 3970-2:1991(2011) Sterilizing and disinfecting equipment for medical products — Part 2 : Specification for steam sterilizers for aqueous fluids in sealed rigid containers
• DIN EN ISO 25424:2022 Sterilization of healthcare products – Low temperature vapor formaldehyde – Requirements for the development, validation and routine monitoring of sterilization procedures for medical devices
• BS 3970-4:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 4 : Specification for transportable steam sterilizers for unwrapped instruments and utensils
• BS 3970-1:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 1 : Specification for general requirements
• BS 3970-5:1990(2011) Sterilizing and disinfecting equipment for medical products — Part 5 : Specification for low temperature steam disinfectors

CEN - European Committee for Standardization, Sterilization product testing

• EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

Professional Standard - Medicine, Sterilization product testing

• YY/T 0567.5-2011 Aseptic processing of health care products.Part 5:Sterilization in place
• YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
• YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization

UNKNOWN, Sterilization product testing

• GB/T 18281.3-2015 Biological Indicators for Sterilization of Healthcare Products Part 3: Biological Indicators for Moist Heat Sterilization
• GB/T 18281.4-2015 Biological Indicators for Sterilization of Healthcare Products Part 4: Biological Indicators for Dry Heat Sterilization
• GB/T 18281.2-2015 Biological indicators for sterilization of healthcare products - Part 2: Biological indicators for ethylene oxide sterilization
• GB/T 18281.5-2015 Biological Indicators for Sterilization of Healthcare Products Part 5: Biological Indicators for Formaldehyde Sterilization by Low Temperature Steam
• GB/T 18282.1-2015 Chemical Indicators for Sterilization of Healthcare Products Part 1: General Rules
• GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices

Professional Standard - Commodity Inspection, Sterilization product testing

• SN/T 3196-2012 Determination of pathogenic vibrio in aquatic product.Automatic detection system for screening pathogenic bacteria
• SN/T 2564-2010 Detection of pathogenic Vibrio in seafood.MPCR-DHPLC
• SN/T 2320-2009 Determination of chlorthalonil,dichlofluanind,tolylfluanid,captan,folpet,captafol and deltamethrin residues in food for import and export.GC/MS method
• SN 0331-1994 Methods for the inspection of bacillus anthraxin animal by-products for export
• SN/T 0331-2013 Method for the inspection of bacillus anthrax in animal by-products for export
• SN/T 1035-2002 Method for the determination of toxic fungal in food for export
• SN/T 2582-2010 Detection of aflatoxigenic strains of Aspergillus by PCR
• SN/T 1962-2007 Detection of klebdella in food
• SN/T 2150-2008 Determination of residues of aldoxycarb,pyraclostrobin,azoxystrobin 65 pesticides in foodstuffs for import and export.LC-MS/MS method
• SN/T 2525-2010 Detection of Clostridium botulinum in foods by PCR
• SN/T 3624-2013 Detemination of Acrobacter in food for export
• SN/T 2641-2010 Detection of pathogen in food.PCR-DHPLC method
• SN/T 2754.10-2011 Loop-mediated isothermal amplification detection method for pathogens in export food.Part 10:Clostridium perfringens

Japanese Industrial Standards Committee (JISC), Sterilization product testing

• JIS T 0806-2:2010 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
• JIS T 0806-2:2014 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
• JIS T 0806-3:2010 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
• JIS T 11737-1:2013 Sterilization of medical devices.Microbiological methods.Part 1: Determination of a population of microorganisms on products
• JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• JIS T 11140-1:2013 Sterilization of health care products.Chemical indicators.Part 1: General requirements

RO-ASRO, Sterilization product testing

• STAS 6348-1985 MILK AND MILK PRODUCTS Pasteurization efficiency control
• STAS 11359/10-1981 NATIVE SULPHUR ORES AND CONCENTRATES Acidity determination

Canadian Standards Association (CSA), Sterilization product testing

• CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
• CSA ISO 14937-01-CAN/CSA:2001-b Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000
• CSA Z11137-3-07-CAN/CSA-2007 St閞ilisation des produits de sant??Irradiation ?Partie 3: Directives relatives aux aspects dosim閠riques premi鑢e 閐ition [Superseded: CSA ISO 11137-98-CAN/CSA]
• CSA ISO 11134-98-CAN/CSA:1998 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization First Edition; ISO 11134: 1994; Supersedes CAN/CSA-Z214.4: 1987
• CSA Z15882-04-CAN/CSA-2004 St閞ilisation des produits de sant??Indicateurs chimiques ?Guide pour la s閘ection, l'utilisation et l'interpr閠ation des r閟ultats Premi鑢e 閐ition
• CSA Z14161-06-CAN/CSA-2006 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results First Edition; ISO 14161:2000
• CSA Z11137-2-07-CAN/CSA-2007 Sterilization of health care products ?Radiation ?Part 2: Establishing the sterilization dose First Edition [Superseded: CSA ISO 11137-98-CAN/CSA, CSA ISO 11137-98-CAN/CSA]
• CSA Z11138-1-07-CAN/CSA-2007 St閞ilisation des produits de sant??Indicateurs biologiques ?Partie 1: Exigences g閚閞ales deuxi鑝e 閐ition
• CSA Z11140-1-07-CAN/CSA-2007 St閞ilisation des produits de sant??Indicateurs chimiques ?Partie 1 : Exigences g閚閞ales deuxi鑝e 閐ition
• CSA ISO 11137-98-CAN/CSA:1998 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization ISO 11137: 1995

Lithuanian Standards Office , Sterilization product testing

• LST EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
• LST EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• LST EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

AENOR, Sterilization product testing

• UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
• UNE-EN ISO 14160:2012 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

AT-ON, Sterilization product testing

• OENORM EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

CH-SNV, Sterilization product testing

• SN EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• 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)

IT-UNI, Sterilization product testing

• UNI EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• UNI EN ISO 11737-1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• 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

国家药监局, Sterilization product testing

• YY/T 1268-2023 Product additions and process equivalence for ethylene oxide sterilization
• YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
• YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes

PL-PKN, Sterilization product testing

• 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 A75052-13-1990 Fruits, vegetables and vegetable-meat products Methods of microbiological analyses Detection of enterococci
• PN A86034-10-1993 Milk and milk products. Microbiological examination. Detection and enumeration of enterococci-colony count technique

TR-TSE, Sterilization product testing

• TS 3446-1979 MEAT AND MEAT PRODUCTS DETECTION OF SALMONELLAE (REFERENCE METHOD)

国家药品监督管理局, Sterilization product testing

• YY/T 1600-2018 Product families and process categories for moist heat sterilization of medical devices

BR-ABNT, Sterilization product testing

• ABNT NBR 14990-8 Errata 1-2013 Packaging system and materials for sterilization of health products Part 8: Packaging envelope and pouches type for sterilization by ionizing radiation

BELST, Sterilization product testing

• STB 1891-2008 Poultry meat, by-products and semi-finished products. Method of the accelerated salmonellae detection

ZA-SANS, Sterilization product testing

• SANS 11135-1:2008 Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• SANS 5762:1975 Examination for the presence of viable Bacillus anthracis in foods

Guangdong Provincial Standard of the People's Republic of China, Sterilization product testing

• DB44/T 445-2007 Examination of Vibrio alginolticus of Aquatic products
• DB44/T 446-2007 Examination of Vibrio vulnificus of Aquatic products

CZ-CSN, Sterilization product testing

• CSN 56 0088-1987 Food products. ethod for the detection of Salmonella
• CSN 56 0096-1988 Food products. etection and enumeration of acteria of the family nterobacteriaceae

海关总署, Sterilization product testing

• SN/T 3244-2020 Inspection Regulations for Imported Fire Protection Products Portable Fire Extinguishers

US-CFR-file, Sterilization product testing

• CFR 9-113.100-2014 Animals and animal products. Part113:Standard requirements. Section113.100:General requirements for inactivated bacterial products.

IL-SII, Sterilization product testing

• S.I.641-1967 TESTING OF MILK AND ITS PRODUCTS: TEST OF STERILITY OF LIQUID PRODUCTS

Indonesia Standards, Sterilization product testing

• SNI 2332.1-2015 Cara uji mikrobiologi - Bagian 1: Penentuan koliform dan Escherichia coli pada produk perikanan
• SNI 01-2329-1991 Fishery products, Determination of Clostridium perfingens

Professional Standard - Environmental Protection, Sterilization product testing

• HJ 1190-2021 Biological assay for the identification of water quality sterilization biological indicators (Bacillus subtilis var. black)

应急管理部, Sterilization product testing

• XF/T 3006-2020 Technical requirements for rapid verification of fire extinguishing agents and fire retardant products

CN-STDBOOK, Sterilization product testing

• 图书 A-4581 Quality and safety detection of fruit and its products Mycotoxins, pathogenic bacteria and fruit components

Association of Official Analytical Chemists (AOAC), Sterilization product testing

• AOAC Official Method 993.10 Determination of Clostridium perfringens in shellfish products

国家市场监督管理总局、中国国家标准化管理委员会, Sterilization product testing

• GB/T 38579-2020 Determination of photosynthetic bacteria in biologic products

国家质量监督检验检疫总局, Sterilization product testing

• SN/T 4963-2017 Testing methods for Aeromonas vitiligo in exported aquatic products

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, Sterilization product testing

• GB/T 19972-2018 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results
• GB/T 19495.9-2017 Detection of genetically modified organisms and derived products—Liquid bead array detection for plant products

Jiangsu Provincial Food Standard of the People's Republic of China, Sterilization product testing

• DBS32/ 004-2014 Rapid detection of pathogenic bacteria in food for the Youth Olympic Games

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