Ethylene oxide sterilization standards and regulations

Ethylene oxide sterilization standards and regulations, Total:131 items.

The international standard classification for "Ethylene oxide sterilization standards and regulations" includes: Sterilizing equipment , Sterilization and disinfection in general , Sterilization and disinfection .

The Chinese standard classification for "Ethylene oxide sterilization standards and regulations" includes: Public medical equipment , Sanitation in general .

Professional Standard - Medicine

YY/T 1268-2023 Product adoption and process equivalence for ethylene oxide sterilization
YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
YY 0503-2016 Ethylene oxide sterilizer
YY 0503-2023 Ethylene oxide sterilizer
YY 0503-2005 Ethylene oxide sterilizer
YY/T 0822-2011 Ethylene oxide liquefied gas for sterilization

未注明发布机构

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
ANSI/AAMI ST24-2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
DIN EN 1422 E:2013-01 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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
CSA Z314.1-2009(R2013) Ethylene oxide sterilizers for health care facilities
DIN EN 1422:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Group Standards of the People's Republic of China

T/ZZB 2701-2022 Industrial ethvlene oxide sterilizer
T/CAMDI 056-2020 Ethylene oxide sterilization process practice of sterile medical device

国家食品药品监督管理局

YY/T 1544-2017 Ethylene oxide sterilization safety and effectiveness basic supply requirements
YY/T 1403-2017 Requirements of contract sterilization using ethylene oxide

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 33419-2016 Test method of biological indicator for ethylene oxide sterilization processes
GB/T 33418-2016 Test method of chemical indicator for ethylene oxide sterilization processes

National Health Commission of the People's Republic of China

GBT 33418-2016 Test method for ethylene oxide sterilization chemical indicator

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

GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization

Taiwan Provincial Standard of the People's Republic of China

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

American National Standards Institute （ANSI)

AAMI TIR14:1997 "Contract sterilization for ethylene oxide, 1ed"
AAMI TIR20:2001 Parametric release for ethylene oxide sterilization
AAMI TIR15:2016(R2020) Physical aspects of ethylene oxide sterilization
AAMI TIR15:2016 Physical aspects of ethylene oxide sterilization
AAMI TIR15:2009 Physical aspects of ethylene oxide sterilization
AAMI TIR14:2016(R2020) Contract sterilization using ethylene oxide
AAMI TIR14:2009 Contract sterilization using ethylene oxide
AAMI TIR14:2016 Contract sterilization using ethylene oxide
ANSI/AAMI ST24-1999 Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
AAMI TIR16:2023 Microbiological aspects of ethylene oxide sterilization
AAMI TIR16:2009 Microbiological aspects of ethylene oxide sterilization
AAMI TIR16:2017 Microbiological aspects of ethylene oxide sterilization
AAMI TIR28:2001 Product adoption and process equivalency for ethylene oxide sterilization
AAMI TIR28:2016(R2020) Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR28:2009 Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR15:1997 Ethylene oxide sterilization equipment, process considerations and pertinent calculations, 1ed
ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization
AAMI/ISO TIR21387:2023 Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

Korean Agency for Technology and Standards (KATS)

KS P ISO 11135-1-2018 Sterilization of health care products — Ethylene oxide
KS P ISO 11135-1:2014 Sterilization of health care products — Ethylene oxide
KS P 6115-2021 Ethylene oxide gas sterilizers for medical use
KS P 6116-2021 Ethylene oxide gas sterilizers for medical use(small size)
KS P ISO 11138-2:2018 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

KR-KS

KS P ISO 11135-1-2014 Sterilization of health care products — Ethylene oxide
KS P ISO 11138-2-2018 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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

Association Francaise de Normalisation

NF EN 1422:2014 Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
NF S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
NF S98-101:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
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
XP ISO/TS 21387:2020 Sterilization of medical devices - Guidelines for validation and routine processing requirements for parametric release ethylene oxide sterilization processes
NF EN ISO 11138-2:2017 Sterilization of healthcare products - Biological indicators - Part 2: biological indicators for sterilization with ethylene oxide

German Institute for Standardization

DIN EN 1422:2014-08 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
DIN EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
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 58948-7:2017-03 Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources

Lithuanian Standards Office

LST EN 1422-1997+A1-2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
LST EN 1422-2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

SCC

NS-EN 1422:2014 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
NS-EN 1422:1997+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
UNE-EN 1422:1998+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DANSK DS/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.
AENOR UNE-EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
CSA Z314.1-M1977-1977 Ethylene Oxide Sterilizers for Hospitals
CAN/CSA-Z314.1-M91-1991 Ethylene Oxide Sterilizers for Hospitals
CAN/CSA Z314.1-M91-1991 Ethylene Oxide Sterilizers for Hospitals
CAN 3-Z314.1-M84-1984 Ethylene Oxide Sterilizers for Hospitals
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
DIN EN 1422 E:2013 Draft Document - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version prEN 1422:2012
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
11/30252448 DC BS EN 1422. Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
AS 1714:1990 Sterilizers - 12/88 ethylene oxide - Hospital use
AS 1714:1975 Ethylene oxide sterilizers (Using Ethyleneoxide/Dichlorodifluoro-methane 12%/88% m/m Sterilizing Gas Mixture) Metric Unit
CAN/CSA-ISO 11135-1998(R2003) Medical devices - Validation and routine control of ethylene oxide sterilization
AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
CAN/CSA Z314.1-2001(R2006) Ethylene Oxide Sterilizers for Health Care Facilities
CAN/CSA-Z314.1-2001(R2007) Ethylene Oxide Sterilizers for Health Care Facilities
NS-EN 1422:1997 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods (Corrigendum AC:2002 incorporated)
AAMI TIR16:2017(R2020) Microbiological aspects of ethylene oxide sterilization [HISTORICAL]
AS 1862:1976 Aeration cabinets (for use with ethylene oxide sterilizers)
CAN/CSA Z314.2-M91-1991 Effective Sterilization in Hospitals by the Ethylene Oxide Process
BS DD CEN/ISO TS 11135-2:2008 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1
CSA Z314.5-1979 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CSA Z314.2-M1977-1977 Effective Sterilization in Hospitals by the Ethylene Oxide Process
CAN 3-Z314.2-M84-1984 Effective Sterilization in Hospitals by the Ethylene Oxide Process
CAN/CSA-Z314.2-M91-1991 Effective Sterilization in Hospitals by the Ethylene Oxide Process
CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA-Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
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
BS EN ISO 10993-7:1996 Biological evaluation of medical devices-Ethylene oxide sterilization residuals
CAN/CSA-Z314.9-M89-1989 Installation and Ventilation of Ethylene Oxide Sterilizers in Health Care Facilities
CAN/CSA Z314.9-M89-1989 Installation and Ventilation of Ethylene Oxide Sterilizers in Health Care Facilities
UNE-EN 866-2:1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 2: PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS.
AAMI 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata
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
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
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

Danish Standards Foundation

DS/EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

European Committee for Standardization (CEN)

EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Incorporates Amendment A1: 2009

AENOR

UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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)

DIN

DIN EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

British Standards Institution (BSI)

BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
BS EN ISO 11138-2:2017 Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
BS EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
BS EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO)

ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11135:1994/Cor 1:1994 Medical devices - Validation and routine control of ethylene oxide sterilization; Technical Corrigendum 1
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

US-AAMI

AAMI TIR16-2009(2013) Microbiological aspects of ethylene oxide sterilization
ANSI/AAMI ST41-2008 Ethylene oxide sterilization in health care facilities: Safety and effectiveness

RU-GOST R

GOST R 57623-2017 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
GOST ISO 11138-2-2012 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization

Canadian Standards Association (CSA)

CSA Z314.1-2009 Ethylene oxide sterilizers for health care facilities (Fifth Edition)
CSA Z314.2-09 UPD 1-2010 Effective sterilization in health care facilities by the ethylene oxide process Fourth 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)

Institute of Electrical and Electronics Engineers (IEEE)

NFPA (Fire) 560 Standard for the Storage, Handling, and Use of Ethylene Oxide for Sterilization and Fumigation, 2007 Edition

BE-NBN

NBN S 31-001-1988 Safe use of ethylene oxide in medical sterilization

National Fire Protection Association (NFPA)

NFPA 560-2006 Standard for the Storage, Handling, and Use of Ethylene Oxide for Sterilization and Fumigation 2007 Edition

GSO

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
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

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