现行

GB/T 16886.7-2015

医疗器械生物学评价　第7部分：环氧乙烷灭菌残留量
Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

2015-12-10

现行

KS P ISO 10993-7

의료기기의 생물학적 평가 — 제7부: 에틸렌 옥사이드 멸균 잔류물
医疗器械的生物学评价第7部分:环氧乙烷灭菌残留物

2022-12-28

现行

ISO 10993-7-2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
医疗器械的生物学评价第7部分:环氧乙烷灭菌残留物

2008-10-13

现行

GOST ISO 10993-7-2016

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации
医疗设备 医疗器械生物学评价 环氧乙烷灭菌残留物

2016-10-25

现行

BS EN ISO 10993-7-2008+A1-2022

Biological evaluation of medical devices-Ethylene oxide sterilization residuals
医疗器械的生物学评价

2022-01-26

现行

UNE-EN ISO 10993-7-2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物（ISO 10993-7-2008）

2009-06-03

现行

AAMI/ISO 10993-7-2008/(R)2012

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)
医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物 包括勘误表（2010）

2007-12-10

现行

UNE-EN ISO 10993-7-1996 ERRATUM

BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).
医疗器械的生物学评估 第7部分:环氧乙烷灭菌残留物 （ISO 10993-7-1995）

1996-06-24

现行

ISO 10993-7-2008/Amd 1-2019

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
新生儿和婴儿允许限值的适用性

2019-12-09

现行

UNE-EN ISO 10993-7-1996

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).
医疗器械的生物学评价 第7部分:环氧乙烷灭菌残留物 （ISO 10993-7-1995）

1996-05-23

现行

YY/T 1267-2015

适用于环氧乙烷灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to ethylene oxide sterilization

2015-03-02

现行

YY/T 0698.7-2009

最终灭菌医疗器械包装材料　第7部分：环氧乙烷或辐射灭菌　无菌屏障系统生产用可密封涂胶纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods

2009-06-16

现行

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

2015-12-10

现行

YY/T 0127.7-2017

口腔医疗器械生物学评价　第7部分：牙髓牙本质应用试验
Biological evaluation of medical devices used in dentistry—Part 7:Pulp and dentine usage test

2017-03-28

现行

DIN EN ISO 11135-1

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
医疗保健产品的灭菌.环氧乙烷.第1部分:医疗器械灭菌过程的开发 验证和常规控制的要求（ISO 11135-1-2007）；德文版EN ISO 11135-1:2007

2007-08-01

现行

BS 05/30141532 DC

ISO/DIS 11135-1. Sterilization of health care products. Ethylene oxide. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/DIS 11135-1 医疗保健产品的消毒 环氧乙烷 第一部分 医疗器械灭菌过程的开发、验证和常规控制要求

2005-11-04

现行

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)
医疗保健产品的灭菌.环氧乙烷.第1部分:医疗器械灭菌过程的开发 验证和常规控制要求（ISO 11135-1-2007）

2007-10-24

现行

YY/T 0681.7-2011

无菌医疗器械包装试验方法　第7部分：用胶带评价软包装材料上印墨或涂层附着性
Test methods for sterile medical device package—Part 7:Evaluating inks or coating adhesion to flexible packaging materials using tape

2011-12-31