Common sterilization methods for surgical instruments and accessories

Common sterilization methods for surgical instruments and accessories, Total:163 items.

The international standard classification for "Common sterilization methods for surgical instruments and accessories" includes: Sterilization and disinfection , Sterilization and disinfection in general , Other standards related to sterilization and disinfection , Laboratory medicine .

The Chinese standard classification for "Common sterilization methods for surgical instruments and accessories" includes: Medical apparatus and devices in general , General and microsurgical devices , Public medical 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
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 0698.6-2009 Packaging materials for terminal sterilized medical devices - Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization pro
YY/T 0970-2013 Validation and routine control of sterilization of liquid sterilants for sterilization of single-use medical devices containing materials of animal origin
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
YY/T 1464-2016 Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices

国家药监局

YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
YY/T 0698.2-2022 Packaging materials for final sterilized medical devices-Part 2: Requirements and test methods for sterilized packaging materials

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

GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 19973.2-2005 Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process
GB/T 19974-2005 GB/T 1997 4-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization proce

未注明发布机构

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
DIN EN 1422:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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 ISO 25424 E:2017-02 Sterilization of medical devices: Development, validation and routine control requirements for low-temperature steam and formaldehyde medical device sterilization processes (draft)
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

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

Association Francaise de Normalisation

NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF S98-103:1994 Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
NF S98-101:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
NF EN ISO 13402:2002 Surgical and dental hand instruments - Determination of resistance to autoclaving, corrosion and exposure to heat
NF EN 1422:2014 Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8: reusable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF S98-051-8*NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF S98-015/IN1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
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 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 S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF 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

SCC

NS-EN 552:1994 Sterilization of medical devices — Validation and routine control of sterilization by irradiation
UNE-EN 552:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
NS-EN 554:1994 Sterilization of medical devices — Validation and routine control of sterilization by moist heat
DANSK DS/EN 552/A1:1999 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
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
MIL MIL-S-36642C-1975 STERILIZER, SURGICAL INSTRUMENT AND DRESSING (S/S BY A-A-50900) (SUPERSEDING MIL-S-36642B)
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 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 868-8:1999 Packaging materials and systems for medical devices which are to be sterilized — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods
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
UNE-EN 868-8:2000 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285. REQUIREMENTS AND TEST METHODS.
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).
NS-EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized — Part 2: Sterilization wrap — Requirements and test methods
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
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
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
07/30167330 DC BS EN 868-8. Packaging materials for terminally sterilized medical devices. Part 8. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
NS-EN 868-8:2009 Packaging for terminally sterilized medical devices — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods
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 11135-1998(R2003) Medical devices - Validation and routine control of ethylene oxide sterilization
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
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
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
UNE-EN 868-2:2000 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 2: STERILIZATION WRAP. 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
05/30066638 DC EN 15424. Sterilization of medical devices. Development, validation and routine control of sterilization processes. Low temperature steam and formaldehyde
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)
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 868-8:2019 Packaging for terminally sterilized medical devices – Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 – Requirements and test methods
AENOR UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
AENOR UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
NS-EN 868-8:2018 Packaging for terminally sterilized medical devices — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods
UNE-EN 1422:1998+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
NS-EN 1422:2014 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
NS-EN 1422:1997+A1:2009 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
UNE-EN 1422:1998 STERILIZERS FOR MEDICAL PURPOSES. ETHYLENE OXIDE STERILIZERS. REQUIREMENTS AND TEST METHODS.
AENOR UNE-EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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
DANSK DS/EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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
NS-EN 868-2:2009 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
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
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
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 EN 868-8 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German and English version prEN 868-8:2017
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)
NS-EN 868-6:2009 Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization processes — Requirements and test methods
DANSK DS/EN 868-2:2017 Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – 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 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the 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)
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

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 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 868-2:2009 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
BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
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 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 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
BS EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat
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 552:1994 Sterilization of medical devices - Validation and routine control of sterilization by irradiation

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 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
EN 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
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
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)

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
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
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
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
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/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 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

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 868-8:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods
DIN EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Danish Standards Foundation

DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 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 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DS/EN 1422+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

CEN - European Committee for Standardization

EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
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

International Organization for Standardization (ISO)

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

German Institute for Standardization

DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
DIN EN 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-8:2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
DIN EN 1422:2014-08 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

RU-GOST R

GOST R ISO 25424-2013 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
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

AENOR

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 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Lithuanian Standards Office

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 868-8-2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
LST EN 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
LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Canadian Standards Association (CSA)

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)

KR-KS

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 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Korean Agency for Technology and Standards (KATS)

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 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

BE-NBN

NBN EN 554-1995 Sterilization of medical devices - Validation and routine control of sterilization by moist heat
NBN EN 552-1995 Sterilization of medical devices - Validation and routine control of sterilization by irradiation

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