ZH
RU
ES

Sterilizer

Sterilizer, Total:499 items.

In the international standard classification, Sterilizer involves: Sterilization and disinfection, Pharmaceutics, Biology. Botany. Zoology, Microbiology, Medical equipment, Agricultural machines, implements and equipment, Vocabularies, Protection against fire, Semiconductor devices, Medical sciences and health care facilities in general, Packaging materials and accessories, Nuclear energy engineering, Pipeline components and pipelines, Electronic component assemblies, Aids for disabled or handicapped persons, Meat, meat products and other animal produce, Analytical chemistry.

European Committee for Standardization (CEN), Sterilizer

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
CEN EN 285-2006 Sterilization - Steam Sterilizers - Large Sterilizers
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN 285:1996 Sterilization - Steam Sterilizers - Large Sterilizers
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 866-3:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
EN 866-6:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
EN 866-2:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 866-5:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 5: Particular Systems for Use in Low Temperature Steam and Formaldehyde Sterilizers
EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Incorporates Amendment A1: 2009
EN 285:2015+A1:2021 Sterilization - Steam sterilizers - Large sterilizers
EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
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 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 866-7:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 7: Particular Requirements for Self-Contained Biological Indicator Systems for Use in Moist Heat Sterilizers
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 866-1:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 1: General Requirements
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 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
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 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 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 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide 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 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)
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/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 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)

Association Francaise de Normalisation, Sterilizer

NF S98-011*NF EN 285:2015+A1:2021:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011/IN1*NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011*NF EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
NF EN 285/IN1:2021 Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
NF S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
NF EN 1422:2014 Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
XP ISO/TS 5111:2023 Recommandations relatives à la qualité de l'eau destinée aux stérilisateurs, à la stérilisation et aux laveurs désinfecteurs de produits de santé
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 14180:2014 Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
NF S98-020:2010 Small steam sterilizers.
NF S98-020/IN2:2010 Small steam sterilizers.
NF S98-020:2015 Small steam sterilizers
NF S98-020*NF EN 13060+A1:2018 Small steam sterilizers
NF S98-020/IN1*NF EN 13060/IN1:2018 Small steam sterilizers
NF EN 13060+A1:2018 Petits stérilisateurs à la vapeur d'eau
NF EN 13060/IN1:2018 Petits stérilisateurs à la vapeur d'eau
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
XP ISO/TS 22421:2021 Stérilisation des produits de santé - Exigences communes applicables aux stérilisateurs utilisés pour la stérilisation terminale des dispositifs médicaux dans les établissements de santé
NF EN 12347:1998 Biotechnologie - Équipement - Critères de performance pour les stérilisateurs à la vapeur d'eau et les autoclaves
NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF S98-051-8*NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF EN 868-8:2018 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 8 : conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d'essai
NF S98-051-8:2009 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods.
NF S98-004-4:2006 Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes.
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 EN 868-2:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : enveloppe de stérilisation - Exigences et méthodes d'essai
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
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 EN 1353:1997 Détermination du taux d'humidité du béton cellulaire autoclavé
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 EN 868-6:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : papier pour des procédés de stérilisation à basse température - Exigences et méthodes d'essai
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 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 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
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 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 S98-004-5:2006 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
NF EN ISO 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 S98-051-7*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 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 S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF S98-103-1/A1:2013 Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
NF EN 868-7:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 7 : papier enduit d'adhésif pour des procédés de stérilisation à basse température - Exigences et méthodes d'essai
NF S98-012/IN2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
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)

AENOR, Sterilizer

UNE-EN 285:2007+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
UNE-EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
UNE-EN 13060:2015 Small steam sterilizers
UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
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 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - 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 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 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 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 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 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 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

Danish Standards Foundation, Sterilizer

DS/EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
DS/EN 285:2021 Sterilization – Steam sterilizers – Large sterilizers
DS/EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 14180+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
DS/EN 13060+A2:2010 Small steam sterilizers
DS/EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized 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 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 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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 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 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 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
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/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/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 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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed 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/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 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

Lithuanian Standards Office , Sterilizer

LST EN 285-2006+A2-2009 Sterilization - Steam sterilizers - Large sterilizers
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 14180-2004+A2-2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
LST EN 12347-2000 Biotechnology - Performance criteria for steam sterilizers and autoclaves
LST EN 13060-2004+A2-2010 Small steam sterilizers
LST EN 868-8-2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
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 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - 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 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 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 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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 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 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 867-5-2002 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
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)

German Institute for Standardization, Sterilizer

DIN EN 285/A1:2018 Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
DIN EN 285:2021-12 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
DIN EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015
DIN EN 285:2021 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
DIN 58953-9:2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container
DIN EN 13060:2023-05 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023 / Note: Date of issue 2023-04-21*Intended as replacement for DIN EN 13060 (2019-02).
DIN 58950-1:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; Text in German and English
DIN 58950-6:2019 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
DIN 58950-3:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-3:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-1:2022-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Vocabulary; Text in German and English
DIN 58950-6:2019-03 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English / Note: DIN 58950-6 (2011-01) remains valid alongside this standard until 2019-08-31.
DIN 58950-3:2021-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English / Note: DIN 58950-3 (2011-01) remains valid alongside this standard until 2022-06-01.
DIN EN 285:2009 Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
DIN EN 1422:2014-08 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
DIN EN 14180:2023 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
DIN EN 12347:1998-06 Biotechnology - Performance criteria for steam sterilizers and autoclaves; German version EN 12347:1998
DIN EN 14180:2023-04 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023 / Note: Date of issue 2023-03-24*Intended as replacement for DIN EN 14180 (2014-09).
DIN EN 14180:2014-09 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
DIN 58950-2:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
DIN 58950-2:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
DIN 58950-2:2021-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English / Note: DIN 58950-2 (2011-01) remains valid alongside this standard until 2022-06-01.
DIN EN 13060:2019-02 Small steam sterilizers; German version EN 13060:2014+A1:2018
DIN EN 17180:2023 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
DIN EN 17180:2023-03 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023 / Note: Date of issue 2023-02-10
DIN 58948-7:2017-03 Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources
DIN 58948-17:2016-10 Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources
DIN 58951-2:2003 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
DIN EN 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-8:2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
DIN 58950-7:2022-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English / Note: DIN 58950-7 (2011-01) remains valid alongside this standard until 2023-05-31.
DIN EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
DIN 58946-7:2014-01 Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities
DIN EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
DIN EN 13060:2023 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023
DIN 58953-8:2019-03 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
DIN 58950-7:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English
DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2023-04 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
DIN 58953-6:2023-11 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN EN 14180:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009
DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN 58951-2:2018-01 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
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 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 13060:2019 Small steam sterilizers (includes Amendment :2018)
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 868-6:2017-05 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 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 58952-3:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
DIN EN 13060:2015 Small steam sterilizers; German version EN 13060:2014
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 EN 13060 Berichtigung 1:2007 Small steam sterilizers; German version EN 13060:2004, Corrigenda to DIN EN 13060:2004-09
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 13060:2009 Small steam sterilizers; German version EN 13060:2004+A1:2009
DIN EN 13060:2010 Small steam sterilizers; German version EN 13060:2004+A2:2010
DIN EN 868-7:2017-05 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
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 11138-5 Berichtigung 1:2007 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-
DIN EN 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 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 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
DIN EN ISO 11137-1:2023-05 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 / Note:...
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...

ES-UNE, Sterilizer

UNE-EN 285:2016+A1:2023 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 13060:2015+A1:2019 Small steam sterilizers
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
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 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 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)

British Standards Institution (BSI), Sterilizer

BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
18/30379433 DC BS EN 285 AMD1. Sterilization. Steam sterilizers. Large sterilizers
PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
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
PD ISO/TS 5111:2022 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
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 13060:2004+A1:2009 Small steam sterilizers
BS EN 13060:2004+A2:2010 Small steam sterilizers
BS EN 13060:2014 Small steam sterilizers
BS EN 13060:2014+A1:2018 Small steam sterilizers
BS EN 13060:2005 Small steam sterilizers
BS EN 13060:2004 Small steam sterilizers
BS EN 13060+A2:2005 Small steam sterilizers
BS EN 13060+A1:2005 Small steam sterilizers
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
BS EN 868-8:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing
23/30457222 DC BS EN 17180. Sterilizers for medical purposes. Low temperature vapourized hydrogen peroxide sterilizers. Requirements and testing
17/30364306 DC BS EN 17180. Sterilizers for medical purposes. Low temperature vaporized hydrogen peroxide sterilizers. Requirements and testing
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
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
BS EN 868-2:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
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 PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN ISO 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 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
BS EN 868-6:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization
BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 11140-6:2022 Tracked Changes. Sterilization of health care products. Chemical indicators. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
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
18/30338923 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
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 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
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
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

US-FCR, Sterilizer

FCR FED H-08-1 SEC 11710-2002 STERILIZERS
FCR FED FCGS 11722-1981 STERILIZERS AND ASSOCIATED EQUIPMENT
FCR COE CEAGS 11710A-1994 WARMING CABINETS, STERILIZERS, AND ASSOCIATED EQUIPMENT
FCR COE CEGS 11710-1999 WARMING CABINETS, STERILIZERS, AND ASSOCIATED EQUIPMENT, NOTICE 1-6 (1999) INCORPORATED

ZA-SANS, Sterilizer

SANS 40:2009 Manually operated medium-vacuum sterilizers (autoclaves)
SANS 982:1990 High-pressure high-vacuum steam sterilizers (autoclaves)
SANS 982:2009 High-pressure high-vacuum steam sterilizers (autoclaves)
SANS 40:1973 Manually operated medium-vacuum sterilizers (autoclaves)
SANS 981:1973 High-pressure down-draught steam sterilizers (autoclaves) (with independent steam supply)

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

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 30690-2014 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer
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/T 19633-2005 Packaging for terminally sterilized medical devices
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 32309-2015 Hydrogen Peroxide Low Temperature Plasma Sterilizer
GB 8599-2023 Technical requirements for large pressure steam sterilizers
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 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 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
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

Professional Standard - Machinery, Sterilizer

JB/T 20001-2011 Sterilizer of parenteral
JB/T 20163-2014 Pharmaceutical dry heating sterilizer
JB 20001-2003 Sterilizer of large capacity infusion and small capacity infusion

Indonesia Standards, Sterilizer

SNI 16-4285-1996 Water sterilizers by ultraviolet rays

BR-ABNT, Sterilizer

ABNT EB-131-1960

Professional Standard - Medicine, Sterilizer

YY 0503-2005 Ethylene oxide sterilizer
YY 1007-2010 Vertical mode steam sterilizers
YY 0503-2023 Ethylene oxide sterilizer
YY 0503-2016 Ethylene oxide sterilizer
YY 0504-2016 Portable Steam Sterilizer
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 1007-2005 Vertical mode steam sterilizers
YY/T 0646-2022
YY 1275-2016 Dry heat (heated air) sterilizers
YY 0504-2005 Portable mode steam sterilizers
YY 0085.2-1992 Forevacuum pressure steam sterilizer
YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
YY/T 0970-2013 Validation and routine control of sterilization of liquid sterilants for sterilization of single-use medical devices containing materials of animal origin
YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY 0679-2008 Sterilizers for medical purposes.Low temperature steam and formaldehyde sterilizers
YY 91111-1999 Series of horizontal autoclave sterilizers
YY 0085.1-1992 Pulse vacuum pressure steam sterilizer
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 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 1277-2016 Biosafety performance requirements for steam sterilizers
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 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
YY 1277-2023 Biosafety performance requirements for pressure steam sterilizers
YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
YY/T 1463-2016 Sterilization validation of medical device.Guidance on selecting a microbial challenge and inoculation sites
YY/T 1263-2015 Evaluation of materials of medical device subject to dry heat sterilization
YY/T 1264-2015 Evaluation of materials of medical device subject to ozone sterilization
YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat sterilization

GOSTR, Sterilizer

GOST R EN 13060-2011 Small steam sterilizers

US-AAMI, Sterilizer

ANSI/AAMI ST8-2013 Hospital steam sterilizers
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

American National Standards Institute （ANSI), Sterilizer

ANSI/AAMI ST55:2016(R2023) Table-top steam sterilizers
ANSI/AAMI ST55-2010 Table-top steam sterilizers
ANSI/AAMI ST50-2004 Dry heat (heated air) sterilizers
ANSI/AAMI/ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ANSI/AAMI/ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ANSI/AAMI/ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ANSI/NFPA 1965-2009 Standard for Fire Hose Appliances
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
ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 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

Korean Agency for Technology and Standards (KATS), Sterilizer

KS P 6130-2020 Table-top steam sterilizers
KS P 6131-2020 Hospital steam sterilizers
KS P 6101-2017 Boiling and steam sterilizer
KS P ISO 11607:2002 Packaging for terminally sterilized medical devices
KS P ISO 11607:2007 Packaging for terminally sterilized medical devices
KS P 6115-2021 Ethylene oxide gas sterilizers for medical use
KS C IEC PAS 62172-2003(2008) Accelerated moisture resistance－Unbiased autoclave
KS P 6116-2021 Ethylene oxide gas sterilizers for medical use(small size)
KS P 1963-2018 Low temperature plasma sterilizer — Performance evaluation
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 6102-2009(2019) High-pressure steam sterilizers for medical use
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 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

国家食品药品监督管理局, Sterilizer

YY/T 1609-2018 Cassette steam sterilizer
YY/T 1007-2018 Vertical steam sterilizer
YY/T 0679-2016 Medical low temperature steam formaldehyde sterilizer
YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
YY/T 1607-2018 Method for setting radiation sterilization dose of medical devices
YY/T 1613-2018 Characteristics and control requirements of medical device irradiation sterilization process
YY/T 1478-2016 Traceability information for sterilization and sterilization of reusable medical devices

未注明发布机构, Sterilizer

BS 3970-4:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 4 : Specification for transportable steam sterilizers for unwrapped instruments and utensils
BS 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 866-4:2000 Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
BS 2646-4:1991(2011) Autoclaves for sterilization in laboratories — Part 4 : Guide to maintenance
BS EN 866-6:2000 Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers
BS EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes Part 3. Particular systems for use in moist heat sterilizers
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN 866-5:2000 Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers
BS EN 866-7:2000 Biological systems for testing sterilizers and sterilization processes - Part 7: Particular requirements for self - contained biological indicator systems for use in moist heat sterilizers
BS 2646-5:1993(2011) Autoclaves for sterilization in laboratories — Part 5 : Methods of test for function and performance
BS EN 866-8:2000 Biological systems for testing sterilizers and sterilization processes - Part 8: Particular requirements for self - contained biological indicator systems for use in ethylene oxide sterilizers
BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes Part 1. General requirements
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS 3970-6:1993(1999) Sterilizing and disinfecting equipment for medical products — Part 6 : Specification for sterilizers using low temperature steam with formaldehyde
BS 3970-2:1991(2011) Sterilizing and disinfecting equipment for medical products — Part 2 : Specification for steam sterilizers for aqueous fluids in sealed rigid containers
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

IN-BIS, Sterilizer

CEN - European Committee for Standardization, Sterilizer

PREN 17180-2017 Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing
EN 285:2015/PRA1:2018 Sterilization - Steam sterilizers - Large sterilizers
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 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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
EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

International Organization for Standardization (ISO), Sterilizer

ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
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 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 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO/DIS 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 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ISO 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 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
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

RU-GOST R, Sterilizer

GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
GOST R 57623-2017 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
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 25375-1982 Methods, means and conditions of sterilisation and disinfection of medical use products. Terms and definitions
GOST R 57622-2017 Specialized food products. Canned sterilized minced meat with biocorrecting effect. Specifications
GOST 19569-1989 Medical steam sterilizers. General technical requirements and test methods

中华全国供销合作总社, Sterilizer

GH/T 1139-2017 "Steam sterilizer for edible fungi culture media"

Professional Standard - Supply and Marketing Cooperative, Sterilizer

GH/T 1417-2023 Steam sterilizer for edible fungi culture medium

工业和信息化部/国家能源局, Sterilizer

JB/T 20171-2016 Medical pure steam sterilizer

PL-PKN, Sterilizer

PN M71061-1969 Enameled cast-iron autoclaves

TH-TISI, Sterilizer

TIS 2665-2014 Small steam sterilizers for medical uses
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

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

T/ZZB 2701-2022 Industrial ethvlene oxide sterilizer
T/SHBX 005-2023 Sterilizable packaging films for medical devices
T/CSPSTC 48-2020 Indoor plasma air sanitization device
T/ZZB 2396-2021 Micro tabletop type B steam sterilizers
T/WSJD 9-2020 Technical guidelines for on-line monitoring of sterilization effect of small pressure steam sterilizers in medical institutions
T/CAME 51-2022 Cleaning, disinfection and sterilization of robotic surgical instruments
T/CASME 325-2023 Testing method for performance of moist heat sterilizer
T/CAMDI 056-2020 Ethylene oxide sterilization process practice of sterile medical device
T/CAMDI 005-2016 Disposable non-sterile liquid filter
T/FDSA 027-2021 General technical criteria of peroxyacetic acid low temperature sterilizer
T/CAMDI 017-2018 Good Manufacturing Practice for Medical Non-Sterile Filters

Japanese Industrial Standards Committee (JISC), Sterilizer

JIS T 7322:1989 High-pressure steam sterilizers for medical use
JIS T 7323:1989 Ethylene oxide gas sterilizers for medical use
JIS T 7324:1989 High-pressure steam sterilizers for medical use (small size)
JIS T 7325:1989 Ethylene oxide gas sterilizers for medical use (small size)
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

KR-KS, Sterilizer

KS P ISO 11607-2002 Packaging for terminally sterilized medical devices
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 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 11137-1-2022 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

CU-NC, Sterilizer

NC 57-70-1985 Table Autoclave Quality Specifications

Military Standards (MIL-STD), Sterilizer

DOD A-A-54708-1992 STERILIZER, SURGICAL INSTRUMENT AND DRESSING (AUTOCLAVE)

Canadian Standards Association (CSA), Sterilizer

CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
CSA ISO 14937-01-CAN/CSA:2001-b Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000
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)
CSA Z314.1-2009 Ethylene oxide sterilizers for health care facilities (Fifth 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 Z314.7-M91-CAN/CSA-1991 Steam Sterilizers Used for Hospitals.General Instruction No 1

国家市场监督管理总局、中国国家标准化管理委员会, Sterilizer

GB/T 15981-2021 Evaluating method for the efficacy of sterilization for disinfection equipment

Professional Standard - Nuclear Industry, Sterilizer

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

(U.S.) Joint Electron Device Engineering Council Soild State Technology Association, Sterilizer

JEDEC JESD22-A102D-2010 Accelerated Moisture Resistance - Unbiased Autoclave
JEDEC JESD22-A102E-2015 Accelerated Moisture Resistance - Unbiased Autoclave

国家药监局, Sterilizer

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

RO-ASRO, Sterilizer

STAS 5206-1956
STAS 11359/10-1981 NATIVE SULPHUR ORES AND CONCENTRATES Acidity determination

Professional Standard - Hygiene , Sterilizer

WS 506-2016 Regulation for disinfection and sterilization technique of dental instruments

International Electrotechnical Commission (IEC), Sterilizer

IEC PAS 62172:2000 Accelerated moisture resistance - Unbiased autoclave

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

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

NZ-SNZ, Sterilizer

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

卫生健康委员会, Sterilizer

WS/T 649-2019 Hygiene requirements for medical low-temperature steam formaldehyde sterilizers

IEC - International Electrotechnical Commission, Sterilizer

PAS 62172-2000 Accelerated Moisture Resistance - Unbiased Autoclave (; Edition 1.0)

Professional Standard - Commodity Inspection, Sterilizer

SN/T 3061-2011 Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices

AT-ON, Sterilizer

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

CH-SNV, Sterilizer

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

IT-UNI, Sterilizer

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

Taiwan Provincial Standard of the People's Republic of China, Sterilizer

CNS 14708-2002 Medical decice-validation and routine control of ethylene oxide strilization

GB-REG, Sterilizer

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

国家药品监督管理局, Sterilizer

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

American Society for Testing and Materials (ASTM), Sterilizer

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

UNKNOWN, Sterilizer

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