Sterilizer Validation

Sterilizer Validation, Total:355 items.

The international standard classification for "Sterilizer Validation" includes: Sterilization and disinfection in general , Sterilizing equipment , Sterilization and disinfection , Other standards related to nuclear energy .

The Chinese standard classification for "Sterilizer Validation" includes: Public medical equipment , Pharmaceutical, safety machinery and tool in general , Medical isotopes , , General and microsurgical devices , Sanitation in general .

国家食品药品监督管理局

YY/T 1608-2018 Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits
YY/T 0679-2016 Low temperature steam and formaldehyde sterilizers for medical purposes

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

GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery
GB 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/T 30690-2014 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer

Professional Standard - Machinery

JB/T 20163-2014 Pharmaceutical Dry Heating Sterilizer

国家市场监督管理总局、中国国家标准化管理委员会

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

Professional Standard - Medicine

YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods

卫生健康委员会

WS/T 649-2019 Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers

British Standards Institution (BSI)

BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 1422:1998 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
BS EN 1422+A1:1998 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
BS EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 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
BS EN ISO 25424:2018+A1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
BS 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 2646-4:1991(2011) Autoclaves for sterilization in laboratories — Part 4 : Guide to maintenance
BS EN ISO 13004:2023 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose. Method VDmaxSD
23/30424625 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS ISO 13004:2022 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS 2646-2:2023 Autoclaves for sterilization in laboratories - Planning and installation. Code of practice
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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
18/30379433 DC BS EN 285 AMD1. Sterilization. Steam sterilizers. Large sterilizers
24/30485888 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
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
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
BS 2646-3:2023 Autoclaves for sterilization in laboratories - Safe use and operation. Code of practice
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
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
18/30338923 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
21/30412844 DC BS EN ISO 22441. Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

SCC

DANSK DS/EN 552/A1:1999 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
NS-EN 552:1994 Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
CAN/CSA-ISO 11137-1998(C2003) Sterilization of medical devices - Requirements for validation and routine control - Sterilization by irradiation
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
CAN/CSA-ISO 11137-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
DANSK DS/EN 285+A1:2021 Sterilization – Steam sterilizers – Large sterilizers
NS-EN 285:2006+A2:2009 Sterilization — Steam sterilizers — Large sterilizers
AENOR UNE-EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
NS-EN 285:2006+A1:2008 Sterilization — Steam sterilizers — Large sterilizers
DANSK DS/EN 285:2016 Sterilization – Steam sterilizers – Large sterilizers
AENOR UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
NS-EN 285:2006 Sterilization — Steam sterilizers — Large sterilizers
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
NS-EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
BS EN 285:1997 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
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
DANSK DS/ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
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...
CAN/CSA-ISO 11134-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
DIN EN 285/A1 E:2018 Draft Document - Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
BS EN ISO 11137-1:2006 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
DANSK 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
CAN/CSA-ISO 20857-2019 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
DIN EN 285 E:2014 Draft Document - Sterilization - Steam sterilizers - Large sterilizers; German version prEN 285:2014
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
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
NS-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)
NS-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)
DANSK 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
05/30066638 DC EN 15424. Sterilization of medical devices. Development, validation and routine control of sterilization processes. Low temperature steam and formaldehyde
07/30157769 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
CAN/CSA-ISO 14937-2001(R2011) 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 11135-1998(R2003) Medical devices - Validation and routine control of ethylene oxide sterilization
NS-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
NS-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)
NS-EN 1422:2014 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
AAMI ST63:2002 Sterilization of health care products - Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices - Dry heat
DANSK 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
DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
NS-EN 1422:1997+A1:2009 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
DANSK DS/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
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
DANSK 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
CAN/CSA-Z17665-1-2009(R2014) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
AENOR 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)
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
AENOR UNE-EN 285/AC:1970 Sterilization. Steam sterilizers. Large sterilizers.
DANSK DS/ISO 11737-2:2020 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
AENOR UNE-EN 285+A1:2008 Sterilization. Steam sterilizers. Large sterilizers.
NS-EN 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 (ISO 14937:2000)
DIN 58929 E:2010 Draft Document - Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes
NS-EN ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
AENOR 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)
AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
BS 2646-1:1988 Autoclaves for sterilization in laboratories-Specification for design and construction
DANSK DS/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
NS-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)
NS-EN ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
AENOR 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)
11/30252448 DC BS EN 1422. Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
NS-EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
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
DANSK DS/CEN ISO/TS 13004:2014 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
07/30164697 DC ISO 20857. Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices
BS 3970-1:1966 Specification for steam sterilizers-Sterilizers for porous loads
BS 3970-2:1966 Specification for steam sterilizers-Sterilizers for bottled fluids
NS-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)
DANSK DS/EN ISO 25424/A1:2019 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)
DIN EN ISO 20857 E:2012 Draft Document - 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 FprEN ISO 20857:2012
NS-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)
AENOR 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)
NS-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 (ISO 11737-2:2009)
DIN EN ISO 17665 E:2022 Draft Document - 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
11/30244091 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
CAN/CSA-Z11135-1-2009(R2014) Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AENOR 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)
04/30048118 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DANSK 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
NS-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)
AAMI TIR76:2021 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
DANSK DS/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
AAMI 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata
AAMI ST46-2002 Steam sterilization and sterility assurance in health care facilities
BS 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
DIN EN ISO 11737-2 E:2018 Draft Document - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018); German and English version prEN ISO 1173...
DANSK DS/ISO 13004:2022 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
NS-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)
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
DIN EN ISO 11135 E:2012 Draft Document - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012

Spanish Association for Standardization (UNE)

UNE-EN 552:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
UNE-EN 554:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
UNE-EN 285:2007+A2:2009 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
UNE-EN 285:2016+A1:2023 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 285:2007 Sterilization - Steam sterilizers - Large sterilizers
UNE-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. (ISO 14937:2000)
UNE-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)
UNE-EN ISO 14160:1998 STERILIZATION OF SINGLE-USE MEDICAL DEVICES INCORPORTING MATERIALS OF ANIMAL ORIGIN. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY LIQUID CHEMICAL STERILANTS. (ISO 14160:1998).
UNE-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
UNE-EN 1422:2014 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.
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 285/AC:1998 STERILIZATION. STEAM STERILIZERS. LARGE STERILIZERS.
UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
UNE-EN ISO 25424:2020 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 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
UNE-EN ISO 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 17665-1:2007 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE-EN ISO 11137-1:2007 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)
UNE-EN ISO 25424:2020/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
UNE-EN ISO 13004:2024 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
UNE-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)

European Committee for Standardization (CEN)

EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
CEN EN 285-2006 Sterilization - Steam Sterilizers - Large Sterilizers
EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
prEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
FprEN 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/FDIS 17665:2023)
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)
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)
EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Incorporates Amendment A1: 2009

Association Francaise de Normalisation

NF EN ISO 14937:2009 Sterilization of healthcare products - General requirements for the characterization of a sterilizing agent and for the development, validation and routine verification of a sterilization process for medical devices
NF S98-011/IN1*NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011*NF EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
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 ISO 20857:2013 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
XP ISO/TS 21387:2020 Sterilization of medical devices - Guidelines for validation and routine processing requirements for parametric release ethylene oxide sterilization processes
NF S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
NF S98-012:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-012*NF EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
NF EN ISO 17665-1:2006 Sterilization of healthcare products - Moist heat - Part 1: requirements for the development, validation and routine control of a medical device sterilization process
NF EN ISO 25424:2019 Sterilization of healthcare products - Formaldehyde and low temperature steam - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 11137-1:2016 Sterilization of health products - Irradiation - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 11135:2014 Sterilization of healthcare products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
NF ISO 22441:2022 Sterilization of healthcare products - Low temperature hydrogen peroxide vapor - Requirements for the 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
GA S98-130:2002 Sterilisation of medical devices - Interpretation guide for NF EN 554 intended for health establishments - Validation and routine inspection for steam sterilisation (October 1994)
NF S98-118-2*NF EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

CEN - European Committee for Standardization

EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
PREN 17180-2017 Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing

Korean Agency for Technology and Standards (KATS)

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 11134:2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11134-2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11134:2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
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
KS P ISO 14937:2018 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devi
KS P ISO 11737-2:2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 22441-2023 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
KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 11737-2:2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

KR-KS

KS P ISO 11137-2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11134-2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11135-2022 Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 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 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 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 11137-1-2019 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 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 11737-2-2021 Sterilization of health care products — Microbiological methods —Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

American National Standards Institute （ANSI)

AAMI TIR35:2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
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
ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
AAMI TIR27:2001 Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax
ANSI/AAMI/ISO 11135:2014 Sterilization of health care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI TIR35:2016 Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
ANSI/AAMI/ISO 17665-1:2006(2013) Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI TIR33:2005 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax

GSO

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/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 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
OS GSO ISO 20857:2016 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 20857:2017 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO 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
GSO ISO 20857:2016 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
OS GSO 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
BH GSO 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
GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
OS GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 25424:2017 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
GSO ISO 11137-1:2014 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
OS GSO ISO 17665-1:2014 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 11737-2:2016 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
OS 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
GSO ISO 17665-1:2014 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO/TS 21387:2023 Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
BH GSO ISO/TS 21387:2023 Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
BH GSO 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
OS GSO ISO 11137-1:2014 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
GSO ISO 22441:2024 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

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 285:1997 Sterilization - Steam sterilizers - Large sterilizers
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 285 E:2014-09 Sterilization - Steam sterilizers - Large sterilizers
DIN EN 285 E:2013-05 Sterilization - Steam sterilizers - Large sterilizers
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 58950-3:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-3:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN EN ISO 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
DIN EN 1422:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 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
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 285:2016 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015
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 1422 E:2013-01 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DIN EN 285:2021 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
DIN EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
DIN EN 14180 E:2012-06 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
DIN EN ISO 13004:2023-03 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German and English version prEN ISO 13004:2023 / Note: Date of issue 2023-02-10*Intended as...
DIN EN ISO 11135 E:2011-09 Requirements for the development, validation and routine control of ethylene oxide medical device sterilization processes for sterilization of healthcare products (draft)
DIN EN ISO 11137-1:2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
DIN EN ISO 25424:2020 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
DIN EN ISO 11135:2024-04 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
DIN 58951-2:2003 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
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 58951:2024-01 Sterilization - Steam sterilizers for laboratory use - Apparatus requirements, requirements on services and installation / Note: Date of issue 2023-11-24*Intended as replacement for DIN 58951-2 (2018-01).
DIN EN ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023
DIN 58953-9:2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container
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 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
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).

Lithuanian Standards Office

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 ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
LST EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
LST EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
LST EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
LST EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

Danish Standards Foundation

DS/EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
DS/EN 285:2021 Sterilization – Steam sterilizers – Large sterilizers
DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
DS/EN 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 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - 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/EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
DS/EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11137-1/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 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/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

International Organization for Standardization (ISO)

ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 13409:2002 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO/TS 15843:2000 Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
ISO 17665:2024 Sterilization of health care products — Moist heat — 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/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 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 14160:2020 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TR 13409:1996 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO/TS 21387:2020 Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

Canadian Standards Association (CSA)

CSA ISO 20857:2019 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
CAN/CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
CAN/CSA-Z11137-1-2007 Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
CAN/CSA-Z11137-2007 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (First Edition)
CSA ISO 14937-01-CAN/CSA:2001-b Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000
CSA ISO 11737-2:2021 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

RU-GOST R

GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests

DIN

DIN 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); German version EN ISO 14160:1998
DIN EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DIN 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); English version of DIN EN ISO 11737-2
DIN 58951:2024 Sterilization - Steam sterilizers for laboratory use - Apparatus requirements, requirements on services and installation

Australian/New Zealand Standard (AU-AS/NZS)

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

TH-TISI

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

US-FCR

FCR FED H-08-1 SEC 11710-2002 STERILIZERS

US-AAMI

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

Japanese Industrial Standards Committee (JISC)

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

South African Bureau of Standard

SANS 40:2009 Manually operated medium-vacuum sterilizers (autoclaves)

IT-UNI

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