Ethylene oxide sterilization air residue

Ethylene oxide sterilization air residue, Total:116 items.

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

The Chinese standard classification for "Ethylene oxide sterilization air residue" includes: Public medical equipment , Medical apparatus and devices in general , Sanitation in general .

Professional Standard - Medicine

YY 0503-2023 Ethylene oxide sterilizer
YY 0503-2016 Ethylene oxide sterilizer
YY 0503-2005 Ethylene oxide sterilizer
YY/T 0822-2011 Ethylene oxide liquefied gas for sterilization

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

GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

Taiwan Provincial Standard of the People's Republic of China

CNS 14393-7-2005 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
CNS 14393.7-2005 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

未注明发布机构

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 ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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
DIN EN ISO 10993-7:2022 Biological assessment of medical devices – Part 7: Ethylene oxide sterilization residues
DIN EN 1422 E:2013-01 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Professional Standard - Pharmaceutical Packaging

YBB 0024-2005 The test method for residue of Ethylene oxide

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 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

SCC

BS EN ISO 10993-7:1996 Biological evaluation of medical devices-Ethylene oxide sterilization residuals
CAN/CSA-ISO 10993.7-1998(R2007) Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
DANSK DS/EN ISO 10993-7/A1:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
DANSK DS/EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
06/30097290 DC ISO 10993-7. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
AS 1714:1975 Ethylene oxide sterilizers (Using Ethyleneoxide/Dichlorodifluoro-methane 12%/88% m/m Sterilizing Gas Mixture) Metric Unit
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
NS-EN ISO 10993-7:1995 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)
CAN 3-Z314.1-M84-1984 Ethylene Oxide Sterilizers for Hospitals
UNE-EN ISO 10993-7:1996 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).
NS-EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
AENOR UNE-EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
CAN/CSA-ISO 10993.7-1998(R2002) Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (Adopted ISO 10993-7:1995)
AS 1862:1976 Aeration cabinets (for use with ethylene oxide sterilizers)
UNE-EN ISO 10993-7:1996 ERRATUM BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).
AS 1714:1990 Sterilizers - 12/88 ethylene oxide - Hospital use
AAMI/ISO TIR19:1998 Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
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
CAN/CSA Z314.1-2001(R2006) Ethylene Oxide Sterilizers for Health Care Facilities
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
CAN/CSA-Z314.1-2001(R2007) Ethylene Oxide Sterilizers for Health Care Facilities
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 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
AAMI TIR16:2017(R2020) Microbiological aspects of ethylene oxide sterilization [HISTORICAL]
11/30252448 DC BS EN 1422. Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
CAN/CSA Z314.2-M91-1991 Effective Sterilization in Hospitals by the Ethylene Oxide Process

British Standards Institution (BSI)

BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-7:2008 Biological evaluation of medical devices - Ethylene oxide sterilization residuals
24/30453916 DC BS EN ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
18/30355036 DC BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization

GSO

GSO ISO 10993-7:2015 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
BH GSO ISO 10993-7:2017 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

VN-TCVN

TCVN 7391-7-2004 Biological evaluation of medial devices.Part 7: Etylen oxide sterilization residuals

Association Francaise de Normalisation

NF EN ISO 10993-7:2008 Biological assessment of medical devices - Part 7: ethylene oxide sterilization residues
NF S99-501-7*NF EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals.
NF EN ISO 10993-7/A1:2022 Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residues - Amendment 1
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.

KR-KS

KS P ISO 10993-7-2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO 10993-7-2022 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
KS P ISO 11135-1-2014 Sterilization of health care products — Ethylene oxide

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-7:2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P 6115-2021 Ethylene oxide gas sterilizers for medical use
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 6116-2021 Ethylene oxide gas sterilizers for medical use(small size)

Japanese Industrial Standards Committee (JISC)

JIS T 0993-7:2012 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

TH-TISI

TIS 2395.7-2008 Biological evaluation of medical devices.part 7: ethylene oxide sterilization residuals

US-AAMI

ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI TIR16-2009(2013) Microbiological aspects of ethylene oxide sterilization

International Organization for Standardization (ISO)

ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008/cor 1:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1

PH-BPS

PNS ISO 10993-7:2021 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

German Institute for Standardization

DIN EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); English version of DIN EN ISO 10993-7:2009-02
DIN EN 1422:2014-08 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
DIN EN ISO 10993-7/A1:2018 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
DIN EN ISO 10993-7:2022-09 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022

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
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
ANSI/AAMI ST24-1999 Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities

AENOR

UNE-EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
UNE-EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

RU-GOST R

GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R 57623-2017 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

ES-UNE

UNE-EN ISO 10993-7:2009/AC:2010 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

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

Danish Standards Foundation

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

GOST

GOST R ISO 10993-7-2009 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

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

DIN

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

Canadian Standards Association (CSA)

CSA Z314.1-2009 Ethylene oxide sterilizers for health care facilities (Fifth Edition)

BE-NBN

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

Others: