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Sterile degassing

Sterile degassing, Total:426 items.

The international standard classification for "Sterile degassing" includes: Ignitability and burning behaviour of materials and products , Domestic electrical appliances in general , Sterilizing equipment , Sterilization and disinfection in general , Sterilization and disinfection , Milk and processed milk products , Other standards related to nuclear energy , Mechanical systems and components for general use (Vocabularies) .

The Chinese standard classification for "Sterile degassing" includes: Plastic profile , Household cleaning and cosmetic appliances , Public medical equipment , Medical apparatus and devices in general , Milk and dairy products , Medical isotopes , Pharmaceutical processing machinery and equipment , Medicinal materials pickoff and Chinese medicine processing machinery , Standardization and quality management .


Group Standards of the People's Republic of China

未注明发布机构

  • DIN EN ISO 11137-1:2006 Sterilization of Health Care Products — Radiation
  • DIN 58948-7 E:2016-07 Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources
  • DIN EN 1422:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • DIN 58950-2 E:2009-09 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements
  • DIN EN 13060 E:2012-06 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
  • 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
  • ANSI/AAMI/ISO 14937:2009(2013) 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
  • DIN EN 285:1997 Sterilization - Steam sterilizers - Large sterilizers
  • DIN EN 1422 E:2013-01 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • ANSI/AAMI/ISO 11140-5:2007(2015) Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
  • ANSI/AAMI/ISO 11137-2:2013(2019) Sterilization of health care products—Radiation— Part 2: Establishing the sterilization dose
  • DIN EN 285 E:2014-09 Sterilization - Steam sterilizers - Large sterilizers
  • DIN EN 285 E:2013-05 Sterilization - Steam sterilizers - Large sterilizers

Professional Standard - Medicine

  • YY/T 0822-2011 Ethylene oxide liquefied gas for sterilization
  • YY 0503-2005 Ethylene oxide sterilizer
  • YY 1275-2016 Dry heat (heated air) sterilizers
  • YY 0503-2023 Ethylene oxide sterilizer
  • YY 1007-2010 Vertical mode steam sterilizers
  • YY 0503-2016 Ethylene oxide sterilizer
  • 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 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilants

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

  • GB 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
  • GB/T 31995-2015 Sterilization of health care products―Radiation―Substantiation of a selected sterilization dose method VDmax
  • GB 18280.2-2015 Sterilization of health care products―Radiation―Part 2:Establishing the sterilization dose
  • GB 5408.2-1999 Sterilized milk
  • GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
  • GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
  • GB 19645-2005 Hygienic standard for pasteurized and sterilized milk
  • GB 18282.5-2015 Sterilization of health care products—Chemical indicators—Part 5:Class 2 indicators for Bowie and Dick-type air removal tests

Yunnan Provincial Standard of the People's Republic of China

  • DB53/T 143.7-2005 Luxi Insecticide Comprehensive Standard Part VII: Avermectin Insecticide Aerosol

Professional Standard - Agriculture

Professional Standard - Machinery

Taiwan Provincial Standard of the People's Republic of China

  • CNS 14709-2002 Sterilization of health care products-requirements for validation and routine control-radiation sterliization
  • CNS 5937-1980 Sterilizing Trays

Jilin Provincial Standard of the People's Republic of China

Professional Standard - Supply and Marketing Cooperative

国家食品药品监督管理局

中华全国供销合作总社

Tianjin Provincial Standard of the People's Republic of China

  • DB12/ 149-2003 Pollution-free food pasteurized milk, sterilized milk

ES-AENOR

German Institute for Standardization

  • DIN EN 285:2021-12 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
  • DIN EN 285/A1:2018 Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
  • 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 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 58950-6:2019-03 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 58950-6:2019 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
  • 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 58950-1:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; 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 EN 285:2009 Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
  • DIN 58953-9:2024 Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers
  • DIN 58950-2:2020 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 13060:2023-05 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 58950-2:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
  • DIN EN 1422:2014-08 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
  • DIN EN ISO 13004:2023-03 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German and English version prEN ISO 13004:2023 / Note: Date of issue 2023-02-10*Intended as...
  • DIN 58952-2:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
  • 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 EN 14180:2014-09 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
  • 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 14180:2023 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 17180:2023 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
  • DIN EN 13060:2019-02 Small steam sterilizers; German version EN 13060:2014+A1:2018
  • 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 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 ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023

SCC

  • DANSK DS/EN 285+A1:2021 Sterilization – Steam sterilizers – Large sterilizers
  • BS EN 285:1997 Sterilization. Steam sterilizers. Large sterilizers
  • NS-EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
  • DANSK DS/EN 285:2016 Sterilization – Steam sterilizers – Large sterilizers
  • NS-EN 285:2006+A1:2008 Sterilization — Steam sterilizers — Large sterilizers
  • AENOR UNE-EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
  • NS-EN 285:2006+A2:2009 Sterilization — Steam sterilizers — Large sterilizers
  • NS-EN 285:2015+A1:2021 Sterilization - Steam sterilizers - Large sterilizers
  • NS-EN 285:1996 Sterilization - Steam sterilizers - Large sterilizers
  • UNE-EN 285:1997 STERILIZATION. STEAM STERILIZERS. LARGE STERILIZERS.
  • UNE-EN 285:2007+A1:2008 Sterilization - Steam sterilizers - Large sterilizers
  • AENOR UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
  • UNE-EN 285:2007 Sterilization - Steam sterilizers - Large sterilizers
  • AAMI ST66:1999 Sterilization of healthcare products - Chemical indicators - Part 2: Class 2 indicators for air removal test
  • NS-EN 285:2006 Sterilization — Steam sterilizers — Large sterilizers
  • DIN EN 285/A1 E:2018 Draft Document - Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
  • DIN EN 285 E:2014 Draft Document - Sterilization - Steam sterilizers - Large sterilizers; German version prEN 285:2014
  • AENOR UNE-EN 285/AC:1970 Sterilization. Steam sterilizers. Large sterilizers.
  • AENOR UNE-EN 285+A1:2008 Sterilization. Steam sterilizers. Large sterilizers.
  • UNE-EN 285/AC:1998 STERILIZATION. STEAM STERILIZERS. LARGE STERILIZERS.
  • BS 3970-2:1966 Specification for steam sterilizers-Sterilizers for bottled fluids
  • BS 3970-1:1966 Specification for steam sterilizers-Sterilizers for porous loads
  • DIN 58953-9 E:2008 Draft Document - Sterilization - Sterile supply - Part 9: Use of sterilization container
  • AAMI/ISO TIR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch
  • CAN/CSA-ISO 11140-5-2018(R2023) Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • CAN/CSA-ISO 11140-5:2018 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • DANSK DS/ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • DANSK DS/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 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
  • DANSK DS/EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • UNE-EN 866-3:1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 3: PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS.
  • DIN 58950-6 E:2018 Draft Document - Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
  • AAMI/ISO 11137-2:2013(R2019) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • AAMI/ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • CAN/CSA-Z11137-2-2007(R2012) Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose
  • DIN 58950-1 E:2009 Draft Document - Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology
  • DANSK DS/EN ISO 11137-2/AC:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • DANSK DS/EN ISO 11137-2/A1:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • AS 1410:1973 Pre-vacuum pressure steam sterilizers (with mechanical air removal)
  • NS-EN 552:1994 Sterilization of medical devices — Validation and routine control of sterilization by irradiation
  • BS 2646-1:1988 Autoclaves for sterilization in laboratories-Specification for design and construction
  • AS 1410:1981 Pre-vacuum pressure steam sterilizers (with mechanical air removal)
  • AWWA PATH50780 The Photocatalytic Inactivation of Clostridium perfringens Spores
  • DANSK DS/EN 552/A1:1999 Sterilization of medical devices - Validation and routine control of sterilization by irradiation
  • CAN/CSA-Z11137-2-2007(C2012) Sterilization of health products - Irradiation - Part 2: Establishment of the sterilizing dose
  • UNE-EN 552:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
  • NS-EN 554:1994 Sterilization of medical devices — Validation and routine control of sterilization by moist heat
  • CAN/CSA-ISO 11137-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
  • BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
  • NS-EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes — Part 3: Particular systems for use in moist heat sterilizers
  • DANSK DS/CEN ISO/TS 13004:2014 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
  • AS 1862:1976 Aeration cabinets (for use with ethylene oxide sterilizers)
  • NS-EN 1422:1997+A1:2009 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
  • NS-EN 1422:2014 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
  • UNE-EN 554:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
  • CAN/CSA-ISO 11137-1998(C2003) Sterilization of medical devices - Requirements for validation and routine control - Sterilization by irradiation
  • DANSK DS/EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • AENOR UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • DANSK DS/ISO/TS 15843:2001 Sterilization of healthcare products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
  • UNE-EN 1422:1998+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • UNE-EN 1422:1998 STERILIZERS FOR MEDICAL PURPOSES. ETHYLENE OXIDE STERILIZERS. REQUIREMENTS AND TEST METHODS.
  • AENOR UNE-EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • NS-EN 12347:1998 Biotechnology — Performance criteria for steam sterilizers and autoclaves
  • AENOR UNE-EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • AAMI TIR37:2013 Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
  • AENOR UNE-EN 866-4:2001 Biological systems for testing sterilizers and sterilization processes. Part 4: Particular systems for use in irradiation sterilizers.
  • DANSK DS/EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • UNE-EN 14180:2004 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • DIN 58948-7 E:2016 Draft Document - Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources
  • UNE-EN 866-2:1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 2: PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS.
  • NS-EN 866-4:1999 Biological systems for testing sterilizers and sterilization processes — Part 4: Particular systems for use in irradiation sterilizers
  • NS-EN 14180:2003+A2:2009 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
  • DIN 58952-2 E:2011 Draft Document - Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
  • NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
  • BS EN ISO 14937:2001 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
  • CAN/CSA-ISO 11134-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
  • UNE-EN 14180:2004+A1:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • NS-EN 866-6:1999 Biological systems for testing sterilizers and sterilization processes — Part 6: Particular systems for use in dry heat sterilizers
  • UNE-EN 866-5:2001 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 5: PARTICULAR SYSTEMS FOR USE IN LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS.
  • NS-EN 14180:2003 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
  • NS-EN 14180:2014 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
  • NS-EN 14180:2003+A1:2009 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
  • UNE-EN 13060:2005+A2:2010 Small steam sterilizers
  • UNE-EN 14180:2004+A2:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • DANSK DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
  • DANSK DS/EN 13060:2015 Small steam sterilizers
  • AAMI ST55:2010 Table-Top Steam Sterilizers
  • UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
  • CAN/CSA-Z314.7-M91-1991(R2000) Steam Sterilizers for Hospitals
  • NS-EN 13060:2004 Small steam sterilizers
  • AWWA WQTC57147 Inactivation Kinetics of Aeromonas hydrophila with Monochloramine
  • NS-EN 866-2:1997 Biological systems for testing sterilizers and sterilization processes — Part 2: Particular systems for use in ethylene oxide sterilizers
  • AAMI/ISO TIR11139:2006 Sterilization of health care products - Vocabulary
  • CAN/CSA Z314.7-M91-1991(R2000) Steam Sterilizers for Hospitals
  • BS 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
  • NS-EN ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
  • NS-EN ISO 11137-2:2012 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
  • UNE-EN 866-6:2001 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 6: PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS.
  • AS 1079:1971 The sterilization of packaged goods
  • UNE 34809:1985 STERILIZED MILK. CONTROL METHOD.
  • AAMI ST55-1997 Table-Top Steam Sterilizers
  • AENOR UNE-EN 13060:2015 Small steam sterilizers
  • UNE-EN 13060:2005 Small steam sterilizers
  • NS-EN 13060:2004+A1:2009 Small steam sterilizers
  • AAMI ST8-2001 Hospital Steam Sterilizers
  • NS-EN 13060:2004+A2:2010 Small steam sterilizers
  • AAMI ST8:2008 Hospital steam sterilizers
  • NS-EN 13060:2014+A1:2018 Small steam sterilizers
  • CAN/CSA-ISO/TS 11139:2018 Sterilization of health care products — Vocabulary
  • UNE-EN 13060:2005+A1:2009 Small steam sterilizers.
  • ADA AAMI ST55:2020 Table-top Steam Sterilizers
  • DIN EN 1422 E:2013 Draft Document - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version prEN 1422:2012
  • NS-EN ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • ADA ST40:2004(R2010) Table-top Dry Heat (heated air) Sterilization and Sterility Assurance in Health Care Facilities
  • DANSK DS/EN 13060+A1:2018 Small steam sterilizers
  • DANSK DS/ISO/TS 11139:2015 Sterilization of health care products – Vocabulary
  • AAMI TIR11139:2002 Sterilization of health care products - Vocabulary
  • NS-EN 13060:2014 Small steam sterilizers
  • ADA ST55:2010 Table-top Steam Sterilizers
  • AENOR UNE-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • NS-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • NS-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
  • AAMI TIR35:2016(R2021) Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
  • CAN/CSA-ISO 14937-2011(R2021) 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 (Adopted ISO 14937:2009, second edition, 2009-10...
  • DANSK DS/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
  • AS 1714:1975 Ethylene oxide sterilizers (Using Ethyleneoxide/Dichlorodifluoro-methane 12%/88% m/m Sterilizing Gas Mixture) Metric Unit
  • AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
  • 11/30252448 DC BS EN 1422. Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
  • DIN 58950-7 E:2009 Draft Document - Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and installation
  • AAMI/ISO 14937:2000 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

Lithuanian Standards Office

Association Francaise de Normalisation

AENOR

  • 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 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
  • UNE-EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • UNE-EN 13060:2015 Small steam sterilizers

Danish Standards Foundation

  • DS/EN 285:2021 Sterilization – Steam sterilizers – Large sterilizers
  • DS/EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
  • DS/ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • DS/EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • 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 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
  • DS/EN 14180+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • DS/EN 13060+A2:2010 Small steam sterilizers

ES-UNE

European Committee for Standardization (CEN)

  • CEN EN 285-2006 Sterilization - Steam Sterilizers - Large Sterilizers
  • EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
  • EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • EN 866-6:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
  • EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
  • EN 866-3:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
  • EN 285:1996 Sterilization - Steam Sterilizers - Large Sterilizers
  • EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
  • EN 866-2:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers
  • prEN ISO 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
  • EN ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

American National Standards Institute (ANSI)

  • ANSI/AAMI ST55-2010 Table-top steam sterilizers
  • ANSI/AAMI ST50-2004 Dry heat (heated air) sterilizers
  • AAMI TIR27:2001 Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax
  • AAMI TIR37:2007 Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products
  • AAMI TIR35:2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
  • ANSI K62.2-1957 Common Name for the Pest Control Chemical 3- (p-Chlorophenyl)-1,1- dimethylurea Monuron
  • AAMI TIR33:2005 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
  • ANSI K62.163-1974 Common Name for the Pest Control Chemical O,O-Diethyl(1,3-dihydro-1,3- dioxo-2H-isoindol-2-yl) phosphonothioate "Ditalimfos"
  • ANSI/AAMI ST40-2004 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
  • ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
  • ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
  • ANSI/AAMI ST55:2016(R2023) Table-top steam sterilizers
  • AAMI TIR35:2016 Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

IN-BIS

International Organization for Standardization (ISO)

  • ISO/CD 11140-5 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • ISO/TR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
  • 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 17665:2023 Sterilization of health care products
  • ISO/FDIS 11137-1:2023 Sterilization of health care products
  • ISO/TR 13409:1996 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
  • ISO/DIS 11135.2:2024 Sterilization of health care products
  • ISO 5553:2024 Meat and meat products
  • 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/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
  • ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization

HU-MSZT

RU-GOST R

  • GOST ISO 11140-5-2011 Sterilization of health care products. Chemical indicators. Part 5. Class 2 indicators for air removal test sheets and packs
  • GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests

GSO

  • GSO ISO 11140-5:2015 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • OS GSO ISO 11140-5:2015 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • BH GSO ISO 11140-5:2016 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • BH GSO 985:2023 Sterilized Milk
  • GSO 985:2023 Sterilized Milk
  • GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • GSO ISO 11137-2:2014 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
  • BH GSO ISO 11137-2:2015 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
  • GSO ISO/TS 13004:2021 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
  • BH GSO ISO/TS 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
  • GSO ISO 14937:2015 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
  • GSO ISO 13408-5:2014 Aseptic processing of health care products -- part 5 : sterilization in place
  • OS GSO ISO/TS 11139:2015 Sterilization of health care products -- Vocabulary
  • GSO ISO/TS 11139:2015 Sterilization of health care products -- Vocabulary
  • GSO ISO 11737-2:2015 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
  • BH GSO ISO/TS 11139:2016 Sterilization of health care products -- Vocabulary

British Standards Institution (BSI)

  • BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
  • BS EN ISO 11137-2:2015+A1:2023 Sterilization of health care products. Radiation - Establishing the sterilization dose
  • 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 11137-2:2007 Sterilization of health care products - Radiation - Establishing the sterilization dose
  • BS ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests
  • BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
  • 18/30379433 DC BS EN 285 AMD1. Sterilization. Steam sterilizers. Large sterilizers
  • BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
  • BS EN 1422+A1:1998 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
  • BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
  • BS EN 1422:1998 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • BS EN ISO 13004:2023 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose. Method VDmaxSD
  • BS ISO 13004:2022 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
  • BS 2646-4:1991(2011) Autoclaves for sterilization in laboratories — Part 4 : Guide to maintenance
  • BS EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • BS 2646-2:2023 Autoclaves for sterilization in laboratories - Planning and installation. Code of practice
  • BS EN 866-4:2000 Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
  • BS EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • BS EN 13060+A1:2005 Small steam sterilizers
  • BS EN 13060:2004 Small steam sterilizers
  • BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
  • BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
  • 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 13060:2014 Small steam sterilizers
  • BS EN 13060:2004+A1:2009 Small steam 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 13060:2005 Small steam sterilizers
  • BS EN 13060+A2:2005 Small steam sterilizers
  • BS EN 13060:2004+A2:2010 Small steam sterilizers
  • BS EN 13060:2014+A1:2018 Small steam sterilizers
  • BS EN ISO 11138-4:2017 Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
  • BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - 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 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods

Korean Agency for Technology and Standards (KATS)

  • KS P 6115-2021 Ethylene oxide gas sterilizers for medical use
  • KS P ISO 11140-5:2020 Sterilization of health care products — Chemical indicators —Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • KS P 6116-2021 Ethylene oxide gas sterilizers for medical use(small size)
  • KS P ISO 11138-3:2012 Sterilization of health care products-Biological indicators-Part 3:Biological indicators for moist heat sterilization processes
  • KS P ISO 11137:2008 Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization
  • 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 11137-2:2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
  • KS P ISO 11137-2:2014 Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
  • KS P ISO 11137-2:2008 Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
  • KS P ISO 11134-2008 Sterilization of health care products-Requirements for validation androutine control-Industrial moist heat 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 M 3841-2019 Sterilized plastic petri dishes
  • KS P ISO 11140-5:2009 Sterilization of health care products-Chemical indicators-Part 5:Class 2 indicators for Bowie and Dick-type air removal tests
  • KS P 6131-2020 Hospital steam sterilizers
  • KS P 6130-2020 Table-top steam sterilizers
  • KS M 3841-1993 Sterilized plastic petri dishes
  • KS P 3007-2013 Sterile filiform acupuncture needles for single use
  • KS P ISO 14937-2023 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

Japanese Industrial Standards Committee (JISC)

ZA-SANS

US-FCR

KR-KS

  • KS P ISO 11140-5-2020 Sterilization of health care products — Chemical indicators —Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
  • KS P ISO 11137-2003 Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization
  • KS P ISO 11137-2-2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
  • KS P ISO 11134-2003 Sterilization of health care products-Requirements for validation androutine control-Industrial moist heat sterilization

U.S. Military Regulations and Norms

NZ-SNZ

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

CZ-CSN

American Society for Testing and Materials (ASTM)

US-AAMI

  • ANSI/AAMI/ISO TIR13004:2013 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose:Method VDmaxSD
  • AAMI TIR37-2013 Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based products
  • ANSI/AAMI ST8-2013 Hospital steam sterilizers

DIN

  • DIN EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
  • DIN EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • DIN EN 13060:2004 Small steam sterilizers

UNKNOWN

  • GB/T 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests

GOST

  • GOST R EN 14180-2008 Sterilizers of the medical purpose. Low temperature steam and formaldehyde sterilizers. Requirements and tests

Canadian Standards Association (CSA)

  • CAN/CSA-Z11137-2-2007 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (First Edition)

BR-ABNT

GOSTR

Indonesia Standards

VN-TCVN

  • TCVN 7393-2-2009 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose

CEN - European Committee for Standardization

  • PREN 17180-2017 Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing