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Sterilizer Validator

Sterilizer Validator, Total:362 items.

In the international standard classification, Sterilizer Validator involves: Sterilization and disinfection, Microbiology, Pharmaceutics, Medical equipment, Dentistry, Quality, Non-destructive testing, Analytical chemistry, Nuclear energy engineering, Testing of metals, Mechanical testing, Construction materials, Vibrations, shock and vibration measurements, Mining equipment, Metrology and measurement in general, Measurement of force, weight and pressure, Linear and angular measurements, Cans. Tins. Tubes, Optics and optical measurements, Textile fibres.

European Committee for Standardization (CEN), Sterilizer Validator

EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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)
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 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Incorporates Amendment A1: 2009
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 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
EN ISO 11137-1:2006/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)
EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
EN ISO 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)
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN ISO 11140-6:2022 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
EN 1174-3:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 3: Guide to the Methods for Validation of Microbiological Techniques
EN ISO/TS 13004:2014 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
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 (ISO 14937:2009)
EN 13860-1:2003 Non destructive testing - Eddy current examination - Equipment characteristics and verification - Part 1: Instrument characteristics and verification
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN ISO 11607-2:2020/prA1 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
EN 12668-1:2010 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Part 1: Instruments

未注明发布机构, Sterilizer Validator

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
DIN EN ISO 25424:2022 Sterilization of healthcare products – Low temperature vapor formaldehyde – Requirements for the development, validation and routine monitoring of sterilization procedures for medical devices
BS 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
BS 2646-4:1991(2011) Autoclaves for sterilization in laboratories — Part 4 : Guide to maintenance
BS 2646-5:1993(2011) Autoclaves for sterilization in laboratories — Part 5 : Methods of test for function and performance
BS EN 61010-2-042:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2 - 042 : Particular requirements for autoclaves and sterilizers using toxic gas for the treatment ofmedical materials, and for laboratory processes

IN-BIS, Sterilizer Validator

IS 5022-1989

Association Francaise de Normalisation, Sterilizer Validator

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 S98-101*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 S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
XP ISO/TS 21387:2020 Stérilisation des dispositifs médicaux - Lignes directrices concernant les exigences de validation et de traitement de routine des procédés de stérilisation à l'oxyde d'éthylène par libération paramétrique
NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
NF S98-012:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-012*NF EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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 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 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 S98-103-1*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
GA S98-130:2002 Sterilisation of medical devices - Interpretation guide for NF EN 554 intended for health establishments - Validation and routine inspection for steam sterilisation (October 1994)
NF S98-118-2*NF EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process
NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
NF EN ISO 11737-2:2020 Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2 : contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation
NF EN ISO 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 S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
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 S98-051-6*NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods
NF S98-052-2*NF EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes
NF EN ISO 11607-2:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage
NF EN ISO 11135/A1:2019 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 - AMENDEMENT 1 : révision de l'Annexe E, Libération ...
NF S98-012/IN2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-051-7*NF EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods
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 11607-2/A11:2022 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement A11
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 E05-059-1:2003 Geometrical products specification (GPS) - Acceptance tests and reverification tests of profile measuring instruments - Part 1 : measuring instruments for areal surface texture.
NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
NF A09-170-1:2008 Non-destructive testing - Equipment for eddy current examination - Part 1 : instrument characteristics and verification.
NF A03-003*NF EN ISO 376:2011 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines.

German Institute for Standardization, Sterilizer Validator

DIN 58951-2:2003 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
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 58950-3:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-3:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
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 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 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 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 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 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 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 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 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
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 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
DIN EN ISO 11737-2:2020-07 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
DIN EN ISO 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 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 14180:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009
DIN 58951-2:2018-01 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
DIN EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
DIN EN ISO 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 11607-2:2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
DIN EN ISO 11607-2/A11:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
DIN EN ISO 11135:2023 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
DIN EN ISO 11137-1:2023 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
DIN 45662:1996 Vibration measuring instrumentation - Fundamental requirements and verification
DIN 45662:1996-12 Vibration measuring instrumentation - Fundamental requirements and verification
DIN EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
DIN EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
DIN EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
DIN EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; English version of DIN EN 868-6:2009-09
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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009
DIN EN ISO 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 58921:2011 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
DIN EN ISO 11607-2/A1:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022 / Note: Date of issu...
DIN EN ISO 376:2011-09 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines (ISO 376:2011); German version EN ISO 376:2011 / Note: DIN EN ISO 376 (2005-02) remains valid alongside this standard until 2011-12-31.
DIN EN 12668-1:2010 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Part 1: Instruments; German version EN 12668-1:2010

CEN - European Committee for Standardization, Sterilizer Validator

EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process
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
PREN 17180-2017 Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing

国家食品药品监督管理局, Sterilizer Validator

YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
YY/T 1623-2018 Test method for effectiveness of sterilization processes for reusable medical devices

Korean Agency for Technology and Standards (KATS), Sterilizer Validator

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 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 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 11737-2:2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 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 11737-2:2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11137-1:2008 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 11607-2:2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2:2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 13402:2019 Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
KS P ISO 14937:2012 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
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 C IEC 61010-2-42-2002(2013) Safety requipements for electrical equipment for measurement, control, and laboratory use－Part 2－42：Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical
KS F 2599-1-2013 Standard test method for the accelerated corrosion of reinforced concrete(autoclave method)
KS F 2599-1-2008 The accelerated corrosion test of reinforced concrete(autoclave method)

KR-KS, Sterilizer Validator

KS P ISO 11137-2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11134-2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
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 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 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 11737-2-2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 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 11737-2-2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11607-2-2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2-2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 13402-2019 Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
KS P ISO 11137-3-2019 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

International Organization for Standardization (ISO), Sterilizer Validator

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/TS 13409:2002 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO/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 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
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/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 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 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 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 21387:2020 Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11140-6:2022 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
ISO 11607-2:2006/Amd 1:2014 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019/FDAmd 1 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
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
ISO 11607-2:2019/Amd 1:2011 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management

Danish Standards Foundation, Sterilizer Validator

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 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 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
DS/EN 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 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 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DS/EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DS/EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
DS/EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
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 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
DS/EN ISO 376:2011 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines

American National Standards Institute （ANSI), Sterilizer Validator

ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI TIR39:2009(R2022) Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
AAMI/ISO TIR21387:2023 Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI/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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterilizer Validator

GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery
GB/T 19973.2-2005 Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
GB 4793.8-2008 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 2-042:Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials,and for laboratory processes

British Standards Institution (BSI), Sterilizer Validator

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 1422:1998 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
BS EN 1422+A1:1998 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
BS EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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 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
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 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
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
BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
PD ISO/TS 21387:2020 Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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
18/30338923 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
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
20/30394635 DC BS 2646-1. Autoclaves for sterilization in laboratories. Part 1. Design, construction, safety and performance. Specification
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 ...
22/30422020 DC BS ISO 11607-2:2019/AMD1. Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
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 7516:1995 Nuclear instrumentation. Liquid-scintillation counting systems. Performance verification
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN 12668-1:2000 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Instruments
BS EN 12668-1:2010 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Instruments
BS 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
BS 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
BS EN ISO 18563-1:2015 Non-destructive testing. Characterization and verification of ultrasonic phased array equipment. Instruments
BS EN ISO 15548-1:2013 Non-destructive testing. Equipment for eddy current examination. Instrument characteristics and verification
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 EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN 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)

RU-GOST R, Sterilizer Validator

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 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
GOST ISO 13402-2011 Surgical and dental hand instruments. Determination of resistance against autoclaving, corrosion and thermal exposure. Test methods
GOST 19569-1989 Medical steam sterilizers. General technical requirements and test methods
GOST R ISO 13402-2008 Surgical and dental hand instruments. Determination of resistance against autoclaving, corrosion and thermal exposure. Test methods
GOST R 8.796-2012 State system for ensuring the uniformity of measurements. Torque measuring devices. Verification procedure

Lithuanian Standards Office , Sterilizer Validator

LST EN 1422-2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
LST EN 1422-1997+A1-2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 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 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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
LST EN 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 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 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
LST EN 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-7-2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
LST EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
LST EN ISO 376:2011 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines (ISO 376:2011)
LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
LST EN 61010-2-042-2000 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes (IEC 61010-2-

AENOR, Sterilizer Validator

UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 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 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 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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
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 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN ISO 376:2011 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines (ISO 376:2011)
UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

Canadian Standards Association (CSA), Sterilizer Validator

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-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 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

NZ-SNZ, Sterilizer Validator

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

ES-UNE, Sterilizer Validator

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 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 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
UNE-EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization...
UNE-EN ISO 11137-1:2015/A2:2020 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
UNE-EN ISO 11135:2015/A1:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
UNE-EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
UNE-EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
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)
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)

TH-TISI, Sterilizer Validator

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

Japanese Industrial Standards Committee (JISC), Sterilizer Validator

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 11737-2:2013 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
JIS B 7728:1997 Calibration of force-proving instruments used for the verification of uniaxial testing machines
JIS B 7728:2013 Calibration of force-proving instruments used for the verification of uniaxial testing machines
JIS B 7728:2002 Calibration of force-proving instruments used for the verification of uniaxial testing machines
JIS T 0806-3:2022 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control
JIS Z 2316-2:2014 Non-destructive testing .Eddy current testing .Part 2: Instrument characteristics and verification

Professional Standard - Medicine, Sterilizer Validator

YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
YY/T 0698.6-2009 Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization
YY/T 0698.7-2009 Packing materials for terminal sterilized medical devices.Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation.Requirements and test methods
YY/T 0698.4-2009 Packaging materials for terminally sterilized medical devices - Part 4: Requirements and test methods for paper bags

US-AAMI, Sterilizer Validator

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

IT-UNI, Sterilizer Validator

UNI EN ISO 11737-2:2021 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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

PT-IPQ, Sterilizer Validator

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)

AT-ON, Sterilizer Validator

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 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)

CH-SNV, Sterilizer Validator

SN EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
SN EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

Professional Standard - Agriculture, Sterilizer Validator

CNAS-GL040-2019 Instrument Validation Implementation Guide

PL-PKN, Sterilizer Validator

PN-EN ISO 11737-2-2020-11 E Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
PN-EN ISO 11135-2014-08/A1-2020-04 P Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018
PN-EN ISO 11607-2-2020-06 P Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

国家药监局, Sterilizer Validator

YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials

Professional Standard - Commodity Inspection, Sterilizer Validator

SN/T 3061-2011 Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
SN/T 3062.2-2011 Pachaking materials for terminally sterilized medical devices for import.Part 2:Paper bags.Requirements and test methods

GOSTR, Sterilizer Validator

GOST ISO 11607-2-2018 Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes

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, Sterilizer Validator

GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process
GB/T 33888-2017 Non-destructive testing instruments—Characterization and verification of ultrasonic thickness measuring equipment

Group Standards of the People's Republic of China, Sterilizer Validator

T/CAQI 107-2020 General Rule for Verificaiton and Evaluation of Analytical Instrument
T/CAQI 328-2023 Specification for verification and evaluation of nitrogen generators for liquid chromatography mass spectrometers

GB-REG, Sterilizer Validator

REG NASA-LLIS-1383-2003 Lessons Learned ?Autoclave Purge Blower Failure

CZ-CSN, Sterilizer Validator

CSN 25 6112-1986 Measuring device for length measuring of abric. Methods for verification
CSN 25 6112-2004 Measuring device for lenght measuring of fabric - Methods for verification

American Society for Testing and Materials (ASTM), Sterilizer Validator

ASTM D4199-82(1998) Standard Test Methods for Autoclavability of Membrane Filters
ASTM E1522-93(1997) Standard Specification for Autoclavable Protective Coatings on Laboratory Glassware
ASTM E1522-93(2019) Standard Specification for Autoclavable Protective Coatings on Laboratory Glassware
ASTM E74-18 Standard Practices for Calibration and Verification for Force-Measuring Instruments
ASTM E74-18e1 Standard Practices for Calibration and Verification for Force-Measuring Instruments
ASTM E2214-16 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments
ASTM E2214-19 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments
ASTM E2214-08 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments
ASTM E2214-18 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments
ASTM E2214-17 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments
ASTM E2214-20 Standard Practice for Specifying and Verifying the Performance of Color-Measuring Instruments

Professional Standard - Machinery, Sterilizer Validator

JB/T 6214-1992 Guideline for reliability validation test and determination test (exponential distribution) for instrumentation
JB/T 6214-2014 Guideline for reliability validation test and determination test (exponential distribution) for instrumentation

机械工业部, Sterilizer Validator

JB/T 56214-1992 Guidelines for instrument reliability verification tests and measurement tests (exponential distribution)

Standard Association of Australia （SAA）, Sterilizer Validator

AS 4489.4.3:1997 Test methods for limes and limestones - Soundness - Autoclave
ISO 11607-2:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — AMENDMENT 1: Application of risk management

Professional Standard - Geology, Sterilizer Validator

DZ/T 0198.11-1997 Guidelines for Process Management of Geological Instruments Process Validation

VN-TCVN, Sterilizer Validator

TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.
TCVN 7392-1-2009 Sterilization of health care products.Ethylene oxide.Part 1: Requirements for developement validation and routine control of a sterilization process for medical devices.

Indonesia Standards, Sterilizer Validator

SNI 18-7027-2004 Nuclear instrumentation - Liquid scintillation counting systems - Performance verification

International Electrotechnical Commission (IEC), Sterilizer Validator

IEC 61304:1994 Nuclear instrumentation - Liquid-scintillation counting systems - Performance verification

Underwriters Laboratories (UL), Sterilizer Validator

UL 61010A-2-042 BULLETIN-2005 UL Standard for Safety Electrical Equipment for Laboratory Use; Part 2: Particular Requirements for Autoclaves and Sterilizers Using Toxic Gas for the Treatment of Medical Materials and for Laboratory Processes
UL 61010A-2-042 (ND)-2002 National Differences For UL 61010A-2-042 Standard for Electrical Equipment for Laboratory Use; Part 2: Particular Requirements for Autoclaves and Sterilizers Using Toxic Gas for the Treatment of Medical Materials@ and for Laboratory Processes (First Editi

Shanxi Provincial Standard of the People's Republic of China, Sterilizer Validator

DB1404/T 18-2021 Inspection and testing laboratory instrument analysis method validation requirements Spectroscopy
DB1404/T 17-2021 Inspection and testing laboratory instrument analytical method validation requirements chromatography

CU-NC, Sterilizer Validator

NC 90-06-39-1984 Metrologleal Assuranoe. Welghing Instrumenta for Plece Computation. Verifioation Methods and Means

Professional Standard - Certification and Accreditation, Sterilizer Validator

RB/T 160-2017 Guidance on verification and overall evaluation of analytical chemistry instrument

ZA-SANS, Sterilizer Validator

SANS 50868-8:2003 Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

YU-JUS, Sterilizer Validator

JUS N.A5.041-1987 Verification mechanical strength resistance ageinst impact. Impact-test apparatus

Xinjiang Provincial Standard of the People's Republic of China, Sterilizer Validator

DB65/T 3920-2016 Cotton quality instrumentation notarization inspection laboratory construction and management specifications