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Preparation sterilization

Preparation sterilization, Total:497 items.

In the international standard classification, Preparation sterilization involves: Sterilization and disinfection, Laboratory medicine, Pharmaceutics, Pesticides and other agrochemicals, Nuclear energy engineering, Products of the chemical industry, Milk and milk products, Farming and forestry, Construction materials, Adhesives, Packaging materials and accessories, Vocabularies, Medical equipment, Sugar. Sugar products. Starch, Veterinary medicine, Food products in general, Radiation measurements, Microbiology, Biology. Botany. Zoology, Fertilizers.

ZA-SANS, Preparation sterilization

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
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 1597:1994 Antiseptics based on chlorhexidine gluconate
SANS 1615:1995 Disinfectants based on glutaraldehyde for general use

British Standards Institution (BSI), Preparation sterilization

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 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
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 11135-1:2007 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
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 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
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 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 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 ISO 25424:2019+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
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
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 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
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 ...
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 EN ISO 11137-3:2007 Sterilization of health care products - Radiation - Guidance on dosimetric aspects
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 ...
23/30426672 DC BS EN 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
17/30363659 DC BS EN ISO 11137-1 AMD2. Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
21/30427336 DC BS EN ISO 25424 AMD1. Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
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 EN ISO 11137-3:2017 Tracked Changes. Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control
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 3970-1:1990 Sterilizing and disinfecting equipment for medical products - Specification for general requirements

International Organization for Standardization (ISO), Preparation sterilization

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/TR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
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 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
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 11137:1995/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 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/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2006/Cor 1:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
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/DIS 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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 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 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 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO/TS 11137-4:2020 Sterilization of health care products — Radiation — Part 4: Guidance on process control
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 11135:1994/Cor 1:1994 Medical devices - Validation and routine control of ethylene oxide sterilization; Technical Corrigendum 1

Professional Standard - Machinery, Preparation sterilization

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

Professional Standard - Medicine, Preparation sterilization

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
YY 0646-2008 Small steam sterilizers.automatic type
YY 0731-2009 Large steam sterilizers.Manual control type
YY/T 0646-2015 Small steam sterilizer automatic control type
YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
YY 1276-2016 Requirements for development, validation and routine control of dry heat sterilization process for medical devices

American National Standards Institute （ANSI), Preparation sterilization

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 ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
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
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
PD CEN ISO/TS 11137-4:2023 Sterilization of health care products. Radiation Guidance on process control (British Standard)
ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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

Danish Standards Foundation, Preparation sterilization

DS/EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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 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/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/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
DS/EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
DS/EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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/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

Association Francaise de Normalisation, Preparation sterilization

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 S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
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 S98-101:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
NF S98-103:1994 Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
NF S98-004-2:2006 Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes.
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
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 S98-101*NF EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the 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 S98-104*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 EN ISO 17665-1:2006 Stérilisation des produits de santé - Chaleur humide - Partie 1 : exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispositifs médicaux
NF P19-101:2008 Prefabricated reinforced components of autoclaved aerated concrete.
NF EN ISO 25424:2019 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
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 S98-112*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 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 ISO 22441:2022 Stérilisation des produits de santé - Vapeur de peroxyde d'hydrogène à basse température - Exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
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*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 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 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 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 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 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 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 S98-101/A1*NF EN ISO 11135/A1:2019 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
NF EN ISO 11137-3:2017 Stérilisation des produits de santé - Irradiation - Partie 3 : directives relatives aux aspects dosimétriques de développement, la validation et le contrôle de routine

ES-UNE, Preparation sterilization

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 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 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 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 (ISO 25424:2018)
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 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 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 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 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)

NZ-SNZ, Preparation sterilization

AS/NZS ISO 11137.2:2006 Sterilization of health care products- Radiation Part 2: Establishing the sterilization dose
AS/NZS 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
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), Preparation sterilization

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 11137:2008 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11137:2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
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 11138-3:2012 Sterilization of health care products-Biological indicators-Part 3:Biological indicators for moist heat sterilization processes
KS P ISO 11134:2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11134:2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
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 11138-5:2020 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 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 11137-1:2008 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 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 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 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 11137-3:2019 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
KS P ISO 11140-1:2012 Sterilization of health care products－Chemical indicators－Part 1：General requirements
KS P ISO 8871-1:2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates

US-AAMI, Preparation sterilization

ANSI/AAMI/ISO TIR13004:2013 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose:Method VDmaxSD
AAMI TIR37-2013 Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based 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
AAMI TIR29-2012 Guide for process characterization and control in radiation sterilization of medical devices
AAMI TIR56-2013 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

KR-KS, Preparation sterilization

KS P ISO 11137-2-2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
KS P ISO 11137-2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
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 11134-2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
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 11135-2022 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 11137-1-2022 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 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 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 11140-2-2002 Sterilization of health care products－Chemical indicators－Part 2：Test equipment and methods
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, Preparation sterilization

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 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 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 58952-2:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
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 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 20857:2013-08 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); German version EN ISO 20857:2013
DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
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 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
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 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; English version of DIN EN 15424:2007-08
DIN 58952-3:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
DIN SPEC 58929:2012-08 Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes / Note: Applies in conjunction with DIN EN ISO 17665-1 (2006-11).
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 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006 / Note: To be replaced b...
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 SPEC 58929:2012 Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes
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 11140-6:2023 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 11137-1:2020-04 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 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); English version of DIN EN ISO 11135-1:2007-08
DIN EN 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 (ISO 25424:2018)
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 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 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014); German version EN ISO 11135:2014
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 11137-1:2023-05 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 25424:2022-07 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019...
DIN EN ISO 11135:2012 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012
DIN 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
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 11135:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
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 25424/A1:2021 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/DAM 1:2021); German and English vers
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

ES-AENOR, Preparation sterilization

Canadian Standards Association (CSA), Preparation sterilization

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)
CAN/CSA-Z11137-2-2007 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (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 PLUS 1173-2012 Guide to the selection and use of sterilization indicators (First Edition)
CAN/CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
CAN/CSA-Z11137-2007 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (First Edition)
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 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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Preparation sterilization

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 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
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/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities
GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
GB 16383-2014 Quality control for radiation sterilization of medical and hygienical products
GB 8599-2008 Technical requirements for large steam sterilizers.Automatic type
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/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects
GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products
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 30393-2013 Multiple microbial agent in straw pretreatment for biogas production

Lithuanian Standards Office , Preparation sterilization

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 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 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 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 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
LST 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 (ISO 11137-1:2006)
LST EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
LST EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
LST EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

AENOR, Preparation sterilization

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 11138-3:2017 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 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 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 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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)
UNE-EN ISO 17665-1:2007 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
UNE-EN ISO 11137-3:2007 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

RO-ASRO, Preparation sterilization

STAS 5206-1956
STAS 6348-1985 MILK AND MILK PRODUCTS Pasteurization efficiency control

国家食品药品监督管理局, Preparation sterilization

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
YY/T 1613-2018 Characteristics and control requirements of medical device irradiation sterilization process

VN-TCVN, Preparation sterilization

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.

European Committee for Standardization (CEN), Preparation sterilization

EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
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 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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 11137-2:2013 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 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
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 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
prEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
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)
prEN ISO 11135 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)
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
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
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 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 25424:2019/prA1:2021 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/DAM 1:2021)
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 25424:2019/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)
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
FprCEN ISO/TS 11137-4 Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
CEN ISO/TS 11137-4:2023 Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
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)

未注明发布机构, Preparation sterilization

BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 25424:2018+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

Taiwan Provincial Standard of the People's Republic of China, Preparation 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 14709-2002 Sterilization of health care products-requirements for validation and routine control-radiation sterliization
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 14621-2002 Sterilization of health care products-requirements for validation and routine control-industrial moist heat 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 14708-2002 Medical decice-validation and routine control of ethylene oxide strilization
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

American Society for Testing and Materials (ASTM), Preparation sterilization

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 D4783-01(2021) Standard Test Methods for Resistance of Adhesive Preparations in Container to Attack by Bacteria, Yeast, and Fungi
ASTM D4783-98a Standard Test Methods for Resistance of Adhesive Preparations in Container to Attack by Bacteria, Yeast, and Fungi
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

RU-GOST R, Preparation sterilization

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 3623-1973 Milk and milk products. Methods for determination of pasteurization
GOST 3623-2015 Milk and milk products. Methods for determination of pasteurization
GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
GOST ISO 11140-1-2011 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST 25375-1982 Methods, means and conditions of sterilisation and disinfection of medical use products. Terms and definitions
GOST R ISO 11134-2000 Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization
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 28085-1989 Biological preparations. Method for the bacteriological control of sterility
GOST ISO 11140-3-2011 Sterilization of care products. Chemical indicators. Part 3. Class 2 indicators for steam penetration test sheets
GOST R ISO 13683-2000 Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities

Group Standards of the People's Republic of China, Preparation sterilization

T/SCSX 0103-2020 "Water Treatment Agent Oxidizing Bactericide and Algaecide" Group Standard
T/DAHEB 006-2019 Hebei Classroom Milk Sterilized Modified Milk
T/QDAS 080-2022 Bacteriophage preparations of Salmonella pullorum
T/WSJD 38-2023 Good Manufacturing Practice for Antimicrobial and Bacteriostatic Preparations
T/SDAA 015-2021 Bacteriophage Preparation for Livestock
T/SHDSGY 127-2022 Donor screening and graft quality control for intestinal flora transplantation
T/SHDSGY 126-2022 Microflora preparations used for intestinal microflora transplantation quality testing specifications
T/CIRA 2-2020 Guidance on radiation sterilization of tissue-based biologics and tissue-derived products
T/CAS 618-2022 General technical requirements for probiotics (Bacillus) preparations for external use in pets
T/CAB 0205-2022 Lipid Nanoparticle-formulated mRNA Sterile Preparations

AT-ON, Preparation sterilization

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 25424/A1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018/DAM 1:2021) (Amendment)

Professional Standard - Nuclear Industry, Preparation sterilization

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

CEN - European Committee for Standardization, Preparation sterilization

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 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices

CH-SNV, Preparation sterilization

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

IT-UNI, Preparation sterilization

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, Preparation sterilization

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 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
YY/T 1733-2020 Guidelines for Dose Distribution Testing of Radiation Sterilization Irradiation Devices for Medical Devices

Japanese Industrial Standards Committee (JISC), Preparation sterilization

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 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
JIS T 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

TH-TISI, Preparation sterilization

TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
TIS 2612.1-2013 Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices

Professional Standard - Hygiene , Preparation sterilization

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

GOSTR, Preparation sterilization

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

Professional Standard - Agriculture, Preparation sterilization

RHB 702-2012 Pasteurized buffalo milk, pasteurized buffalo milk and reconstituted buffalo milk
RHB 802-2012 Pasteurized yak milk, sterilized yak milk and modulated yak milk
1336药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Bacillus subtilis and Enterococcus Dual Live Bacteria Preparations
1331药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Bifidobacterium Live Bacteria Preparations
349药典四部-2020 9000 Guidelines 9207 Guidelines for Biological Indicators for Sterilization
1332药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Bifidobacterium Triple Live Bacteria Preparations
1291药典化学药和生物制品卷-2010 Chapter 18 Biological Products 2. Bacterial Preparations Corynebacterium brevis
1297药典化学药和生物制品卷-2010 Chapter 18 Biological Products 2. Bacterial Preparations Pseudomonas
NY 293-1995 Bacillus thuringiensis preparation
1295药典化学药和生物制品卷-2010 Chapter 18 Biological Products II. Bacterial Preparations Group A Streptococcus
1296药典化学药和生物制品卷-2010 Chapter 18 Biological Products II. Bacterial Preparations Pseudomonas aeruginosa
1292药典化学药和生物制品卷-2010 Chapter 18 Biological Products 2. Bacterial Preparations for Therapeutic Brucella
831兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Butyric Acid Bacteria Live Bacteria Preparation
1293药典化学药和生物制品卷-2010 Chapter 18 Biological Products 2. Bacterial Preparations BCG Polysaccharides and Nucleic Acids
873兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Bifidobacterium, Lactobacillus, Faecalis Streptococcus, Yeast Complex Live Bacteria Preparation
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)
1335药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Live Bacillus cereus
1337药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Microecological Preparations Lactobacillus Acidophilus Preparations
1334药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Bacillus licheniformis Preparations
827兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standards Bacillus cereus and Streptococcus faecalis live bacterial preparations
1333药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Bifidobacterium Quadruple Live Bacteria Tablets
728兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Bacteroides fragilis, Streptococcus faecalis, Bacillus cereus complex bacterial preparation
1060兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Instructions for Butyric Bacteria Live Bacteria Preparations
1298药典化学药和生物制品卷-2010 Chapter 18 Biological Products 2. Bacterial Preparations Nocardia rubrum Cell Wall Skeleton
1338药典化学药和生物制品卷-2010 Chapter 18 Biological Products VII. Probiotics Clostridium Butyricum Preparations
1056兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Instructions for Bacillus cereus and Streptococcus faecalis Live Bacteria Preparations
829兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standards Live Bacillus cereus Preparations (SA38)
828兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standards Live Bacillus cereus Preparations (DM423)
1071兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Instructions for Inactivated Pasteurella Multocida Oil Emulsion Vaccine (TJ Strain)

BR-ABNT, Preparation sterilization

ABNT NB-166-1971

Professional Standard - Forestry, Preparation sterilization

LY/T 1181-1995 Bacillus thuringiensis preparation

Professional Standard - Light Industry, Preparation sterilization

QB/T 4091-2010 Sugar industry aid.Bacteriostatic agent (Types of organic sulfur)

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, Preparation sterilization

GB/T 36030-2018 General technical requirements of CIP and SIP for pharmaceutical machinery

BE-NBN, Preparation sterilization

NBN-ISO 8421-5:1992 Fire protection. Vocabulary. Part 5: Smoke control

UNKNOWN, Preparation sterilization

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

IX-FAO, Preparation sterilization

CAC/RCP 15-1976(En) Hygienic operating procedures for egg products (including microbiological requirements for sterilized egg products)
CAC/RCP 61-2005(Ch) Reduce and control antimicrobial resistance and operating procedures for safe use of antimicrobials
CAC/RCP 61-2005(En) Reduce and control antimicrobial resistance and operating procedures for safe use of antimicrobials

Inner Mongolia Provincial Standard of the People's Republic of China, Preparation sterilization

DB15/T 3149-2023 Technical regulations for detection of resistance of Sclerotinia sclerotiorum to sterol demethylation inhibitor fungicides

PT-IPQ, Preparation sterilization

NP EN ISO 14160:2000 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants(ISO 14160-1998)