1 甲基环氧乙烷检测标准，1 甲基环氧乙烷检测标准标准内容,检测中心-北检（北京）检测技术研究院

GB 18279.1-2015

医疗保健产品灭菌　环氧乙烷　第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求
Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

【发布单位或类别】 CN-GB国家标准
【发布日期】2015-12-10
【CCS分类】C47公共医疗设备
【ICS分类】11.080.01消毒和灭菌综合

YY/T 1302.1-2015

环氧乙烷灭菌的物理和微生物性能要求　第1部分：物理要求
Physical requirements and microbiological performance of ethylene oxide sterilization—Part 1: Physical aspects

【发布单位或类别】 CN-YY行业标准-医药
【发布日期】2015-03-02
【CCS分类】C47公共医疗设备
【ICS分类】11.080.01消毒和灭菌综合

T/SDSCCE 031-2022

2-[2-(4-氯苯基)乙基]-2-(1,1-二甲基乙基)-环氧乙烷

【发布单位或类别】 CN-TUANTI团体标准
【发布日期】2022-05-23
【CCS分类】一般有机化工原料
【ICS分类】71.100.01化工产品综合

BS DD CEN/ISO TS 11135-2:2008

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1
Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

【发布单位或类别】 GB-BSI英国标准学会
【发布日期】2009-07-31
【CCS分类】公共医疗设备
【ICS分类】杀虫剂和其他农用化工产品综合

SAE AMST81533A

Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing
Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing

【发布单位或类别】 US-SAE美国机动车工程师协会
【发布日期】2007-04-13
【CCS分类】医疗器械
【ICS分类】消毒和灭菌综合

32018D1463

Council Implementing Decision (EU) 2018/1463 of 28 September 2018 on subjecting the new psychoactive substances N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopropanecarboxamide (cyclopropylfentanyl) and 2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide (methoxyacetylfentanyl) to control measures

【发布单位或类别】 IX-EURLEX欧洲技术法规
【发布日期】2018-09-28
【CCS分类】G17一般有机化工原料
【ICS分类】65.100.01消毒和灭菌

AAMI TIR14:1997/A1:2004

Contract Sterilization for Ethylene Oxide, Includes Amendment 1
Contract Sterilization for Ethylene Oxide, Includes Amendment 1

【发布单位或类别】 US-AAMI美国医疗器械促进协会
【发布日期】2004-07-15
【CCS分类】公共医疗设备
【ICS分类】脂族烃

EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

【发布单位或类别】 IX-CEN欧洲标准化委员会
【发布日期】2019-11-20
【CCS分类】C47医疗器械
【ICS分类】11.080.01消毒设备

EN ISO 10993-7:2008/A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

【发布单位或类别】 IX-CEN欧洲标准化委员会
【发布日期】2022-01-12
【CCS分类】C30/49卫生综合
【ICS分类】11.080消毒和灭菌

UNE-CEN ISO/TS 11135-2:2009 EX

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

【发布单位或类别】 ES-UNE西班牙标准
【发布日期】2009-09-02
【CCS分类】卫生综合
【ICS分类】消毒和灭菌综合

CSA Z314.2-09

Effective sterilization in health care facilities by the ethylene oxide process, Includes Update No. 1 (2010), Update No. 2 (2010)
Effective sterilization in health care facilities by the ethylene oxide process, Includes Update No. 1 (2010), Update No. 2 (2010)

【发布单位或类别】 CA-CSA加拿大标准协会
【发布日期】2009-03-01
【CCS分类】
【ICS分类】消毒和灭菌

GB/T 13098-2006

工业用环氧乙烷
Ethylene oxide for industrial use

【发布单位或类别】 CN-GB国家标准
【发布日期】2006-01-23
【CCS分类】G17
【ICS分类】71.080.10消毒和灭菌

YY 0503-2023

环氧乙烷灭菌器
Ethylene oxide sterilizer

【发布单位或类别】 CN-YY行业标准-医药
【发布日期】2023-06-20
【CCS分类】C47
【ICS分类】11.080.10

EN ISO 10993-7:2008/AC:2009

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

【发布单位或类别】 IX-CEN欧洲标准化委员会
【发布日期】2009-11-15
【CCS分类】C30/49
【ICS分类】11.080

KS P ISO TS 11135-2-2014

보건의료제품 멸균?산화에틸렌?제2부: KS P ISO 11135－1의 적용에 관한 지침
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135－1

【发布单位或类别】 KR-KS韩国标准
【发布日期】2014-12-01
【CCS分类】
【ICS分类】11.080.01

UNE-EN ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

【发布单位或类别】 ES-UNE西班牙标准
【发布日期】2007-10-24
【CCS分类】
【ICS分类】

GB/T 33418-2016

环氧乙烷灭菌化学指示物检验方法
Test method of chemical indicator for ethylene oxide sterilization processes

【发布单位或类别】 CN-GB国家标准
【发布日期】2016-12-30
【CCS分类】C50
【ICS分类】11.080

GB/T 33419-2016

环氧乙烷灭菌生物指示物检验方法
Test method of biological indicator for ethylene oxide sterilization processes

【发布单位或类别】 CN-GB国家标准
【发布日期】2016-12-30
【CCS分类】C59
【ICS分类】11.080

BS ISO 17280:2015

Surface active agents. Determination of 1,4-dioxan residues in surfactants obtained from epoxyethane by gas chromatography
Surface active agents. Determination of 1,4-dioxan residues in surfactants obtained from epoxyethane by gas chromatography

【发布单位或类别】 GB-BSI英国标准学会
【发布日期】2015-06-30
【CCS分类】
【ICS分类】

MIL MIL-T-81533A Notice 2-Cancellation

Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing (No S/S Document)
Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing (No S/S Document)

【发布单位或类别】 US-MIL美国军事规范和标准
【发布日期】2016-07-03
【CCS分类】
【ICS分类】

1 甲基环氧乙烷检测标准

医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

环氧乙烷灭菌的物理和微生物性能要求 第1部分：物理要求 Physical requirements and microbiological performance of ethylene oxide sterilization—Part 1: Physical aspects

2-[2-(4-氯苯基)乙基]-2-(1,1-二甲基乙基)-环氧乙烷

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing Trichloroethane 1, 1, 1, (Methyl Chloroform) Inhibited, Vapor Degreasing

Contract Sterilization for Ethylene Oxide, Includes Amendment 1 Contract Sterilization for Ethylene Oxide, Includes Amendment 1

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008) Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

Effective sterilization in health care facilities by the ethylene oxide process, Includes Update No. 1 (2010), Update No. 2 (2010) Effective sterilization in health care facilities by the ethylene oxide process, Includes Update No. 1 (2010), Update No. 2 (2010)

工业用环氧乙烷 Ethylene oxide for industrial use

环氧乙烷灭菌器 Ethylene oxide sterilizer