Sterilization in situ

Sterilization in situ, Total:405 items.

The international standard classification for "Sterilization in situ" includes: Alcoholic beverages , Milk and processed milk products , Sterilization and disinfection , Sterilization and disinfection in general , Other standards related to nuclear energy , Laboratory medicine , Sterilizing equipment , Mechanical systems and components for general use (Vocabularies) .

The Chinese standard classification for "Sterilization in situ" includes: Basic standards and general methods , Milk and dairy products , Public medical equipment , Medical isotopes , Medical apparatus and devices in general , Pharmaceutical, safety machinery and tool in general , 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

T/SDAS 244-2021 Inactivated lactic acid bacteria powder
T/CAS 871-2024 Disinfected egg
T/GDID 1013-2020 Bactericidal and algicidal agent
T/SRX 006-2022 sterilized goat milk
T/IMAS 043-2022 Sterilized goat milk
T/CBJ 3303-2022 pecification for high-temperature short-time (HTST) pasteurized beer and its production
T/CAAA 008-2019 Sterilized camel milk
T/QGCML 1353-2023 Technical specifications for sterilization of medicinal tea raw materials
T/SRX 006-2023 Sterilized goat milk

Professional Standard - Agriculture

349药典四部-2020 9000 Guidelines 9207 Guidelines for Biological Indicators for Sterilization
359药典三部-2020 Other 1421 sterilization methods
QB/T 8042-2024 Sterilized milk process specifications
NY/T 939-2016 Identification of reconstituted milk in pasteurized and UHT milk
2406药典二部-2010 APPENDIX XVII STERILIZATION
1831药典一部-2010 Appendix XVI Sterilization Methods
农业部1818号公告-1-2012 Actinobacillus pleuropneumoniae subunit inactivated vaccine (imported veterinary drug registration)
286药典三部-2010 Appendix XV Sterilization
NY/T 939-2005 Identification of reconstituted milk in pasteurized and UHT milk

Hunan Provincial Standard of the People's Republic of China

DB43/T 2086-2021 Technical specification for strong reduction sterilization of vegetable greenhouse soil

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

GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
GB/T 19973.2-2005 Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process
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/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB/T 30690-2014 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer
GB 19645-2005 Hygienic standard for pasteurized and sterilized milk
GB 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer

Xinjiang Provincial Standard of the People's Republic of China

DB65/T 2176-2004 Rules of Disinfecting Sterilization in Medical Institute on Plateau

Professional Standard - Medicine

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 0503-2016 Ethylene oxide sterilizer
YY 0503-2023 Ethylene oxide sterilizer
YY 1007-2010 Vertical mode steam sterilizers
YY 0503-2005 Ethylene oxide sterilizer
YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilants
YY/T 1463-2016 Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

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

Taiwan Provincial Standard of the People's Republic of China

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

Professional Standard - Machinery

JB/T 20001-2011 Sterilizer of parenteral
JB/T 20119-2009 ot-air circulation sterilzing cabinet
JB/T 20163-2014 Pharmaceutical Dry Heating Sterilizer

Jilin Provincial Standard of the People's Republic of China

DB22/T 281-2019 Fungal Laboratory Disinfection and Sterilization Methods

Professional Standard - Supply and Marketing Cooperative

GH/T 1417-2023 Edible fungus cultivate medium steam sterilizers

中华全国供销合作总社

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

国家食品药品监督管理局

YY/T 1609-2018 Cassette steam sterilizer
YY/T 1007-2018 Vertical steam sterilizers

RU-GOST R

GOST R ISO 13408-5-2011 Aseptic processing of health care products. Part 5. Sterilization in place
GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
GOST R 57623-2017 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

American National Standards Institute （ANSI)

AAMI TIR13:1997 Principles of industrial moist heat sterilization, 1ed
AAMI TIR27:2001 Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax
AAMI TIR35:2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
AAMI TIR37:2007 Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products
ANSI/AAMI/ISO 11137-2:2013(2019) Sterilization of health care products—Radiation— Part 2: Establishing the sterilization dose
AAMI TIR33:2005 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
ANSI K62.163-1974 Common Name for the Pest Control Chemical O,O-Diethyl(1,3-dihydro-1,3- dioxo-2H-isoindol-2-yl) phosphonothioate "Ditalimfos"
ANSI/AAMI ST55-2010 Table-top steam sterilizers
ANSI/AAMI ST55:2016(R2023) Table-top steam sterilizers
ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
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/ISO 13408-4:2005(2014) Aseptic processing of health care products — Part 4: Clean-in-place technologies
AAMI TIR35:2016 Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

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 285 E:2014-09 Sterilization - Steam sterilizers - Large sterilizers
DIN EN 285 E:2013-05 Sterilization - Steam sterilizers - Large sterilizers
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 58950-3:2021 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 58950-1:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; 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 58950-1:2022-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Vocabulary; 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 EN 285:2009 Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
DIN 58950-2:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
DIN 58953-9:2024 Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers
DIN 58950-2 E:2009-09 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements
DIN 58950-2:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
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 58950-2:2021-06 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 1422:2014-08 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
DIN 58952-2:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
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 1422:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 13060 E:2012-06 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
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 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 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
DIN EN 12347:1998-06 Biotechnology - Performance criteria for steam sterilizers and autoclaves; German version EN 12347:1998
DIN EN 14180:2023-04 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023 / Note: Date of issue 2023-03-24*Intended as replacement for DIN EN 14180 (2014-09).
DIN EN ISO 11137-1:2006 Sterilization of Health Care Products — Radiation
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 EN 1422 E:2013-01 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 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
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 14180 E:2012-06 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
DIN 58948-17:2016-10 Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources

SCC

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
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
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.
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
AWWA WQTC65789 Evaluation of Challenge Organisms for UV Inactivation of Pathogens
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
DIN 58950-6 E:2018 Draft Document - Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
DANSK DS/EN ISO 11137-2/AC:2009 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/A1:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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
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
CAN/CSA-Z11137-2-2007(C2012) Sterilization of health products - Irradiation - Part 2: Establishment of the sterilizing dose
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
CAN/CSA-ISO 11137-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
DANSK DS/CEN ISO/TS 13004:2014 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
NS-EN 1422:2014 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
NS-EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes — Part 3: Particular systems for use in moist heat sterilizers
NS-EN 1422:1997+A1:2009 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
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
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
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 1422+A1:2009 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
NS-EN 12347:1998 Biotechnology — Performance criteria for steam sterilizers and autoclaves
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
NS-EN 866-4:1999 Biological systems for testing sterilizers and sterilization processes — Part 4: Particular systems for use in irradiation sterilizers
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.
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
NS-EN 14180:2003+A2:2009 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
NS-EN 14180:2014 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing
NS-EN 14180:2003 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
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
DANSK DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
CAN/CSA-ISO 11134-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
AAMI/ISO TIR11139:2006 Sterilization of health care products - Vocabulary
CAN/CSA Z314.7-M91-1991(R2000) Steam Sterilizers for Hospitals
NS-EN 866-2:1997 Biological systems for testing sterilizers and sterilization processes — Part 2: Particular systems for use in ethylene oxide sterilizers
NS-EN ISO 11137-2:2012 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
NS-EN ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
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
CAN/CSA-Z314.7-M91-1991(R2000) Steam Sterilizers for Hospitals
NS-EN 13060:2004 Small steam sterilizers
NS-EN 13060:2014+A1:2018 Small steam sterilizers
AAMI ST8:2008 Hospital steam sterilizers
NS-EN 13060:2004+A2:2010 Small steam sterilizers
DIN 58952-2 E:2011 Draft Document - Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
CAN/CSA-ISO/TS 11139:2018 Sterilization of health care products — Vocabulary
ADA AAMI ST55:2020 Table-top Steam Sterilizers
AENOR UNE-EN 13060:2015 Small steam sterilizers
AAMI ST8-2001 Hospital Steam Sterilizers
NS-EN 13060:2004+A1:2009 Small steam 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
NS-EN ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
ADA ST55:2010 Table-top Steam Sterilizers
DANSK DS/EN 13060+A1:2018 Small steam sterilizers
DANSK DS/ISO/TS 11139:2015 Sterilization of health care products – Vocabulary
NS-EN 13060:2014 Small steam sterilizers
AAMI TIR11139:2002 Sterilization of health care products - Vocabulary
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/EN 13060:2015 Small steam sterilizers
AAMI ST55:2010 Table-Top Steam Sterilizers
AAMI ST55-1997 Table-Top Steam Sterilizers
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
AENOR UNE-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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
DANSK DS/ISO 13004:2022 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
CAN/CSA-ISO 11139-2019 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
NS-EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes — Part 1: General requirements
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
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

GSO

GSO ISO 13408-4:2014 Aseptic processing of health care products -- part 4 : clean-in-place technologies
BH GSO 985:2023 Sterilized Milk
GSO 985:2023 Sterilized Milk
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 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 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
GSO ISO/TS 11139:2015 Sterilization of health care products -- Vocabulary
OS GSO ISO 13408-4:2014 Aseptic processing of health care products -- part 4 : clean-in-place technologies

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 14180-2004+A2-2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
LST EN 12347-2000 Biotechnology - Performance criteria for steam sterilizers and autoclaves
LST EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
LST EN 13060-2004+A2-2010 Small steam sterilizers

Association Francaise de Normalisation

NF S98-011/IN1*NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011*NF EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF EN ISO 11137-2:2015 Sterilization of health products - Irradiation - Part 2: establishment of the sterilizing dose
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
NF S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
NF EN 1422:2014 Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
NF S98-131*NF EN ISO 11139:2018 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
NF S98-012:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-012*NF EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
NF EN 14180:2014 Sterilizers for medical use - Low temperature steam and formaldehyde sterilizers - Requirements and tests
NF ISO 13004:2022 Sterilization of health products - Irradiation - Justification of the chosen sterilizing dose: DVmaxD method
NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF EN 13060/IN1:2018 Small steam sterilizers
NF S98-020*NF EN 13060+A1:2018 Small steam sterilizers
NF S98-020/IN2:2010 Small steam sterilizers.
NF S98-020:2010 Small steam sterilizers.
NF S98-020:2015 Small steam sterilizers
NF EN ISO 11137-2/A1:2023 Sterilization of health products - Irradiation - Part 2: establishment of the sterilizing dose - Amendment 1
NF EN 13060+A1:2018 Small steam sterilizers
XP ISO/TS 5111:2023 Water quality recommendations for healthcare product sterilizers, sterilization and washer-disinfectors
NF S98-020/IN1*NF EN 13060/IN1:2018 Small steam sterilizers

Spanish Association for Standardization (UNE)

UNE-EN 285:2007+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 285:2007 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 285:2016+A1:2023 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/AC:1998 STERILIZATION. STEAM STERILIZERS. LARGE STERILIZERS.
UNE 111-750-1989 Sterilization. Large capacity steam. Effective sterilization monitoring
UNE 111-725-1989 Sterilization. Sterile paper for bag and test tube manufacturing
UNE-EN 866-3:1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 3: PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS.
UNE-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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.
UNE-EN 14180:2004 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 866-2:1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 2: PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS.
UNE-EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
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.
UNE-EN 14180:2004+A2:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 13060:2005+A2:2010 Small steam sterilizers
UNE-EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 14180:2004+A1:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
UNE-EN 866-6:2001 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 6: PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS.
UNE 34-809-1985 Sterilized milk. Control Method
UNE-EN 13060:2005+A1:2009 Small steam sterilizers.
UNE-EN 13060:2015+A1:2019 Small steam sterilizers
UNE-EN 13060:2005 Small steam sterilizers
UNE-EN 13060:2015 Small steam sterilizers
UNE 34809:1985 STERILIZED MILK. CONTROL METHOD.
UNE-EN ISO 13004:2024 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
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)

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 866-3:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN 285:1996 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)

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 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 14180+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
DS/EN 13060+A2:2010 Small steam sterilizers
DS/EN 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

HU-MSZT

MNOSZ 2354-1956 Sterilize

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 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 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS EN 1422+A1:1998 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
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 2646-4:1991(2011) Autoclaves for sterilization in laboratories — Part 4 : Guide to maintenance
BS ISO 13004:2022 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
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 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
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 13060:2004 Small steam sterilizers
BS EN 13060+A1:2005 Small steam sterilizers
BS EN 13060:2004+A1:2009 Small steam sterilizers
BS EN 13060:2014 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 13060:2014+A1:2018 Small steam sterilizers
BS EN 13060:2005 Small steam sterilizers
BS EN 13060:2004+A2:2010 Small steam sterilizers
BS EN 13060+A2:2005 Small steam sterilizers
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 ISO 11138-4:2017 Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
PD ISO/TS 5111:2022 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS EN 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
BS EN 868-8:2018 Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

Standard Association of Australia （SAA）

AS T55:1971 Horizontal rectangular sterilizers (downward displacement pressure steamtype)
AS T54:1971 Horizontal cylindrical sterilizers (downward displacement pressure steamtype)
AS 1714:1975 Ethylene oxide sterilizers (Using Ethyleneoxide/Dichlorodifluoro-methane 12%/88% m/m Sterilizing Gas Mixture) Metric Unit
AS 1079:1971 The sterilization of packaged goods

South African Bureau of Standard

SANS 1678:2010 Sterilized milk
SANS 40:2009 Manually operated medium-vacuum sterilizers (autoclaves)
SANS 1679:2010 Pasteurized milk
SANS 5002:1987 Sterility of liquids
SANS 1679:2001 Pasteurized milk
SANS 5001:1971 Sterility testing: sampling, criteria of compliance of a batch with sterility requirements
SANS 5003:1987 Sterility of solid materials

US-FCR

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

BSI

DIN EN 17971:2024 Devices for in-situ generation of biocides - Ozone; German version EN 17971:2024

International Organization for Standardization (ISO)

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/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 5553:2024 Meat and meat products
ISO/FDIS 11137-1:2023 Sterilization of health care products
ISO/DIS 11135.2:2024 Sterilization of health care 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 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

CZ-CSN

CSN ON 56 9343-1967 DIA． Sterilized cucumber

IN-BIS

IS 4238-1967 Sterilized milk specifications
IS 5567-1970 Specification for sterilized baby bottles
IS 4884-1968 Sterilized cream specifications
IS 3829 Pt.3-1985 Specifications for steam sterilizers Part 3 Pressure sterilizers, vertical cylindrical type

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

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

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 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 11137-2:2020 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 M 3841-2019 Sterilized plastic petri dishes
KS P ISO 11134:2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P 6131-2020 Hospital steam sterilizers
KS P 6130-2020 Table-top steam sterilizers
KS P 3007-2013 Sterile filiform acupuncture needles for single use
KS M 3841-1993 Sterilized plastic petri dishes
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

KR-KS

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
KS P ISO 11139-2020 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

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