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box + sterilizer

box + sterilizer, Total:332 items.

In the international standard classification, box + sterilizer involves: Sterilization and disinfection, Pharmaceutics, Pesticides and other agrochemicals, Nuclear energy engineering, Products of the chemical industry, Laboratory medicine, Packaging materials and accessories, Medical equipment, Food products in general, Radiation measurements, Microbiology, General methods of tests and analysis for food products.

British Standards Institution (BSI), box + sterilizer

BS EN ISO 11137-2:2015+A1:2023 Sterilization of health care products. Radiation - Establishing the sterilization dose
BS EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Establishing the sterilization dose
BS ISO 13004:2022 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS EN ISO 13004:2023 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose. Method VDmaxSD
BS EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide 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 11137-2:2012 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
21/30426910 DC BS EN ISO 11137-2 AMD. Sterilization of health care products. Radiation. Part 2. 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 11138-2:2006 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 11138-3:2009 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 11138-4:2017 Tracked Changes. Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
BS 6734:2004 Antimicrobial efficacy of disinfectants for veterinary and agricultural use - Method
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 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 11138-5:2017 Tracked Changes. Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
BS EN 1040:2005 Chemical disinfectants and antispetics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
BS EN 868-7:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
21/30431923 DC BS ISO 13004. Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VD<sub>max</sub><sup>SD</sup>
BS EN ISO 11137-3:2007 Sterilization of health care products - Radiation - Guidance on dosimetric aspects
BS ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests
BS EN ISO 11140-3:2010 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 14160:2021 Tracked Changes. 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 ...
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
18/30363974 DC BS EN ISO 14160. 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 ...
BS EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
BS ISO 11040-4:2015+A1:2020 Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling
BS EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
BS ISO 11040-6:2019 Tracked Changes. Prefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling
BS EN ISO 11137-3:2017 Tracked Changes. Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control

Professional Standard - Machinery, box + sterilizer

JB/T 20001-2011 Sterilizer of parenteral
JB 20001-2003 Sterilizer of large capacity infusion and small capacity infusion

International Organization for Standardization (ISO), box + sterilizer

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/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 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>
ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
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 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 14160:2020 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
ISO 11137-2:2006/Cor 1:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
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 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11138-7:2019 Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
ISO/CD 11140-3 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 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
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 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

American National Standards Institute （ANSI), box + sterilizer

ANSI K62.163-1974 Common Name for the Pest Control Chemical O,O-Diethyl(1,3-dihydro-1,3- dioxo-2H-isoindol-2-yl) phosphonothioate "Ditalimfos"
ANSI K62.25-1961 Common Name for the Pest Control Chemical N- (Trichloromethylthio) phthalimide Folpet
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 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
ANSI/AAMI/ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 11138-8:2023 Sterilization of health care products -Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator
ANSI/AAMI/ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicators systems for use in the Bowie and Dick steam penetration test
ANSI/AAMI/ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
ANSI/AAMI/ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

Danish Standards Foundation, box + sterilizer

DS/EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
DS/EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
DS/EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
DS/EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
DS/EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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/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/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 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
DS/EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
DS/ISO 11138-8:2021 Sterilization of health care products – Biological indicators – Part 8: Method for validation of a reduced incubation time for a biological indicator
DS/EN ISO 11138-8:2021 Sterilization of health care products – Biological indicators – Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
DS/EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
DS/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

Association Francaise de Normalisation, box + sterilizer

NF EN ISO 11137-2:2015 Stérilisation des produits de santé - Irradiation - Partie 2 : établissement de la dose stérilisante
NF EN ISO 11138-3:2017 Stérilisation des produits de santé - Indicateurs biologiques - Partie 3 : indicateurs biologiques pour la stérilisation à la chaleur humide
NF EN ISO 11138-4:2017 Stérilisation des produits de santé - Indicateurs biologiques - Partie 4 : indicateurs biologiques pour la stérilisation à la chaleur sèche
NF EN ISO 11138-2:2017 Stérilisation des produits de santé - Indicateurs biologiques - Partie 2 : indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène
NF ISO 13004:2022 Stérilisation des produits de santé - Irradiation - Justification de la dose stérilisante choisie : méthode DVmaxD
NF S98-004-3*NF EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes
NF EN ISO 11137-2/A1:2023 Stérilisation des produits de santé - Irradiation - Partie 2 : établissement de la dose stérilisante - Amendement 1
NF S98-004-4*NF EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes
NF S98-004-2*NF EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes
NF EN ISO 11138-5:2017 Stérilisation des produits de santé - Indicateurs biologiques - Partie 5 : indicateurs biologiques pour la stérilisation à la vapeur d'eau et au formaldéhyde à basse température
NF S98-004-5*NF EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde 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 S98-004-3:2006 Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes.
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 S98-004-2:2006 Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes.
NF EN ISO 11140-6:2022 Stérilisation des produits de santé - Indicateurs chimiques - Partie 6 : indicateurs de type 2 et dispositifs d'épreuve de procédé destinés à être utilisés pour les essais de performances relatifs aux petits stérilisateurs à la vapeur d'eau
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 T72-152:1997 Chemical disinfectants and antiseptics. Basic bactericidal activity. Test method and requirements (phase 1).
NF T72-202:1997 Chemical disinfectants and antiseptics. Basic fungicidal activity. Test method and requirements (phase 1).
NF EN ISO 15882:2010 Stérilisation des produits de santé - Indicateurs chimiques - Directives pour la sélection, l'utilisation et l'interprétation des résultats
NF T72-202*NF EN 1275:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
NF S98-004-8*NF EN ISO 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8 : method for validation of a reduced incubation time for a biological indicator
NF EN ISO 11138-8:2021 Stérilisation des produits de santé - Indicateurs biologiques - Partie 8 : méthode pour la validation d'un temps d'incubation réduit pour un indicateur biologique
NF T72-602*NF EN 14561:2007 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in medical area - Test method and requirements (phase 2, step 2)
NF T72-171:1988 WATER MISCIBLE ANTISEPTICS AND DISINFECTANTS USED IN LIQUID FORM. DETERMINATION OF BACTERICIDAL ACTIVITY IN THE PRESENCE OF SPECIFIC INTERFERING SUBSTANCES (MEMBRANE FILTRATION METHOD).
NF T72-204:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticical activity of chemical desinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1).
NF S98-112*NF 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
NF S98-112:2011 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
NF EN ISO 14160:2021 Stérilisation des produits de santé - Agents stérilisants chimiques liquides pour dispositifs médicaux non réutilisables utilisant des tissus animaux et leurs dérivés - Exigences pour la caractérisation, le développement, la validation et le c...
NF EN ISO 11138-7:2019 Stérilisation des produits de santé - Indicateurs biologiques - Partie 7 : directives générales pour la sélection, l'utilisation et l'interprétation des résultats
NF EN ISO 11140-3:2009 Stérilisation des produits de santé - Indicateurs chimiques - Partie 3 : systèmes d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration de la vapeur
NF S93-006-6*NF ISO 11040-6:2019 Prefilled syringes - Part 6 : plastic barrels for injectables and sterilized subassembled syringes ready for filling
NF T72-206*NF EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in medical area - Test method and requirements (phase 2, step 2)
NF T72-170:1988 WATER MISCIBLE AND NEUTRALIZABLE ANTISEPTICS AND DISINFECTANTS USED IN LIQUID FORM. DETERMINATION OF BACTERICIDAL ACTIVITY IN THE PRESENCE OF SPECIFIC INTERFERING SUBSTANCES (DILUTION-NEUTRALISATION METHOD).

ES-UNE, box + sterilizer

UNE-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
UNE-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)
UNE-EN ISO 11140-6:2023 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)
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 11138-8:2022 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
UNE-EN ISO 11138-7:2020 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
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)

NZ-SNZ, box + sterilizer

AS/NZS ISO 11137.2:2006 Sterilization of health care products- Radiation Part 2: Establishing the sterilization dose
AS/NZS ISO 11137.3:2006 Sterilization of health care products- Radiation Part 3: Guidance on dosimetric aspects

Korean Agency for Technology and Standards (KATS), box + sterilizer

KS P ISO 11137-2:2008 Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
KS P ISO 11137-2:2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
KS P ISO 11137-2:2014 Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
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 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 11137-3:2008 Sterilization of health care products－Radiation－Part 3：Guidance on dosimetric aspects
KS P ISO 11140-2:2002 Sterilization of health care products－Chemical indicators－Part 2：Test equipment and methods
KS P ISO 11140-2:2007 Sterilization of health care products-Chemical indicators-Part 2:Test equipment and methods
KS P ISO 11140-1:2012 Sterilization of health care products－Chemical indicators－Part 1：General requirements
KS P ISO 11140-5:2009 Sterilization of health care products-Chemical indicators-Part 5:Class 2 indicators for Bowie and Dick-type air removal tests
KS P ISO 11138-7:2021 Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
KS P ISO 11140-3:2009 Sterilization of health care products-Chemical indicators-Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
KS P ISO 11140-4:2009 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 11137-3:2019 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
KS P ISO 8871-1:2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates

US-AAMI, box + sterilizer

ANSI/AAMI/ISO TIR13004:2013 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose:Method VDmaxSD
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

KR-KS, box + sterilizer

KS P ISO 11137-2-2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
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 11140-2-2002 Sterilization of health care products－Chemical indicators－Part 2：Test equipment and methods
KS P ISO 11138-7-2021 Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
KS P ISO 11137-3-2019 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
KS P ISO 8871-1-2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates

German Institute for Standardization, box + sterilizer

DIN EN ISO 13004:2023-03 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German and English version prEN ISO 13004:2023 / Note: Date of issue 2023-02-10*Intended as...
DIN EN ISO 11138-3:2017-07 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017
DIN EN ISO 11138-4:2017-07 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
DIN EN ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023
DIN EN ISO 11138-2:2017-07 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017
DIN EN ISO 11137-2:2023-08 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023
DIN EN ISO 11138-5:2017-07 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
DIN CEN ISO/TS 13004:2014-10*DIN SPEC 13223:2014-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014
DIN EN ISO 11137-2/A1:2021 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021
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 EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017
DIN EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
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 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017
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 13004:2023-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German version EN ISO 13004:2023
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 11140-4:2007 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 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
DIN EN ISO 11138-1:2017-07 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017
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 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 11140-6:2023 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)
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 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
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 15882:2008-12 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); German version EN ISO 15882:2008
DIN EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
DIN EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015
DIN EN 1275:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1); English version of DIN EN 1275:2
DIN EN ISO 11138-8:2021-11 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021
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 11138-7:2019-11 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019
DIN EN 1657:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1); English
DIN 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
DIN EN ISO 11140-3:2009-09 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, including Cor 1:2007); German version EN ISO 11140-3:2009 / Note: DIN EN ISO 11...
DIN EN ISO 11140-3 Berichtigung 1:2008 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, Corrigendum to DIN EN ISO 11140-3:2007-07; Ge
DIN EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) English version of DIN EN 14562:2006-08
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 1657:2016 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1); German v
DIN EN ISO 11140-1 Berichtigung 1:2007 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005, Corrigenda to DIN EN ISO 11140-1:2006-04
DIN ISO 11040-4:2017-07 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
DIN ISO 11040-6:2021-05 Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, box + sterilizer

GB 18280.2-2015 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
GB/T 31995-2015 Sterilization of health care products.Radiation.Substantiation of a selected sterilization dose method VD<下标max>
GB/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects

RO-ASRO, box + sterilizer

STAS 5206-1956

国家食品药品监督管理局, box + sterilizer

YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
YY/T 1607-2018 Method for setting radiation sterilization dose of medical devices

VN-TCVN, box + sterilizer

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.

Lithuanian Standards Office , box + sterilizer

LST EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
LST 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)
LST EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
LST 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)
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 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)
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
LST EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
LST EN ISO 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

Canadian Standards Association (CSA), box + sterilizer

CAN/CSA-Z11137-2-2007 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (First Edition)
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 PLUS 1173-2012 Guide to the selection and use of sterilization indicators (First 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 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 Z15882-09-CAN/CSA-2009 Sterilization of health care products ?Chemical indicators ?Guidance for selection, use and interpretation of results Second Edition
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

European Committee for Standardization (CEN), box + sterilizer

prEN ISO 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
EN ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
CEN ISO/TS 13004:2014 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
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 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
EN 866-8:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 8: Particular Requirements for Self-Contained Biological Indicator Systems for Use in Ethylene Oxide Sterilizers
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 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 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998
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 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
EN 1040:1997 Chemical Disinfectants and Antiseptics - Basic Bactericidal Activity - Test Method and Requirements (Phase 1)
prEN ISO 11140-6:2021 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/DIS 11140-6:2021)
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 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development@ validation and routine control
EN 1275:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
EN 1275:1997 Chemical Disinfectants and Antiseptics - Basic Fungicidal Activity - Test Method and Requirements (Phase 1)
EN ISO/TS 13004:2014 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
EN ISO 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
prEN ISO 11140-3 rev Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
EN 1657:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1) (Incorpor
EN 1657:2016 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2@ step 1)
EN 1657:2000 Chemical Disinfectants and Antiseptics - Quantitative Suspension Test for the Evaluation of Fungicidal Activity of Chemical Disinfectants and Antiseptics Used in Veterinary Field - Test Method and Requirements (Phase 2, Step 1)
EN ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

Taiwan Provincial Standard of the People's Republic of China, box + sterilizer

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 14623.1-2002 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
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

Professional Standard - Medicine, box + sterilizer

YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
YY/T 0970-2013 Validation and routine control of sterilization of liquid sterilants for sterilization of single-use medical devices containing materials of animal origin

US-FCR, box + sterilizer

FCR UFGS-21 13 21.00 20-2009 FOAM FIRE EXTINGUISHING FOR FUEL TANK PROTECTION

American Society for Testing and Materials (ASTM), box + sterilizer

ASTM E1054-21 Standard Test Practices for Evaluation of Inactivators of Antimicrobial Agents
ASTM E1054-21e1 Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
ASTM E1054-22 Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
ASTM E1054-08(2013) Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
ASTM E1054-08 Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
ASTM E2274-09 Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants
ASTM E2406-09 Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations
ASTM E2406-04 Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations
ASTM E3178-18 Standard Practice for Evaluating Static and Cidal Chemical Decontaminants against Bacillus Spores using Centrifugal Filtration Tubes

AENOR, box + sterilizer

UNE-EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
UNE-EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
UNE-EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
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 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
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 11137-3:2007 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

RU-GOST R, box + sterilizer

GOST R 50325-2011 Medical products. Radiation sterilization. Dosimetric techniques
GOST ISO 11137-2-2011 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
GOST ISO 11140-1-2011 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO 11140-5-2011 Sterilization of health care products. Chemical indicators. Part 5. Class 2 indicators for air removal test sheets and packs
GOST ISO 11140-3-2011 Sterilization of care products. Chemical indicators. Part 3. Class 2 indicators for steam penetration test sheets
GOST 8.651-2016 State system for ensuring the uniformity of measurements. Medical products. Radiation sterilization. Dosimetric techniques
GOST ISO 11140-4-2011 Sterilization of health care products. Chemical indicators. Part 4. Class 2 indicators for steam penetration test packs

Group Standards of the People's Republic of China, box + sterilizer

T/SCSX 0103-2020 "Water Treatment Agent Oxidizing Bactericide and Algaecide" Group Standard

AT-ON, box + sterilizer

OENORM EN ISO 11137-2/A1:2021 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013/DAmd 1:2021) (Amendment)
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
OENORM EN ISO 11140-6:2021 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/DIS 11140-6:2021)
OENORM EN ISO 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

Professional Standard - Nuclear Industry, box + sterilizer

EJ/T 1243-2017 Bioburden data analysis method for confirming radiation sterilization dose for radiation sterilization of medical devices

CEN - European Committee for Standardization, box + sterilizer

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
EN ISO 11138-7:2019 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection@ use and interpretation of results
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

ZA-SANS, box + sterilizer

SANS 5004:1987 Sterility of antibiotics and preparations containing antibiotics
SANS 11138-3:2007 Sterilization of health care products - Biological indicators Part 3: Biological indicators for moist heat sterilization processes

Japanese Industrial Standards Committee (JISC), box + sterilizer

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 11140-1:2013 Sterilization of health care products.Chemical indicators.Part 1: General requirements
JIS T 0806-3:2022 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control

Professional Standard - Hygiene , box + sterilizer

WS/T 327-2011 Requirements of mycobactericidal evaluation for disinfectant in laboratory

GOSTR, box + sterilizer

GOST 30392-1995 Medical products. Dosimetric techniques for radiation sterilization

Professional Standard - Agriculture, box + sterilizer

349药典四部-2020 9000 Guidelines 9207 Guidelines for Biological Indicators for Sterilization
农业部公告第1754号 Imported veterinary drug registration catalog: 1. Porcine atrophic rhinitis inactivated vaccine; 2. Chicken egg drop syndrome inactivated vaccine (BC14 strain); 3. Chicken viral arthritis inactivated vaccine (1733 strains + 2408 strains); 4. Tylosin Phosp
842兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Avian Pasteurella Multocida Oil Emulsion Inactivated Vaccine (TJ Strain)

CH-SNV, box + sterilizer

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 11138-8:2021 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

IT-UNI, box + sterilizer

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

国家药监局, box + sterilizer

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
YY/T 1733-2020 Guidelines for Dose Distribution Testing of Radiation Sterilization Irradiation Devices for Medical Devices

BR-ABNT, box + sterilizer

ABNT NB-166-1971

Standard Association of Australia （SAA）, box + sterilizer

AS/NZS 4276.3.2:2003 Water microbiology - Heterotrophic colony count methods - Plate count of water containing biocides

Professional Standard - Commodity Inspection, box + sterilizer

SN/T 1889.5-2007 Minimal dose in irradiation resistance on harmful microorganism in export and import food.Part 5:Fusarium graminearum
SN/T 1889.1-2007 Minimal dose of irradiation resistance on harmful microorganism in import and export foods.Part 1: Fusarium moniliforme shield

国家质量监督检验检疫总局, box + sterilizer

SN/T 1889.5-2016 Minimum irradiation dose for killing harmful microorganisms in imported and exported foods Part 5: Fusarium graminearum