现行

KS P 6115(2016 Confirm)

의료용 산화에틸렌 가스 멸균 장치
环氧乙烷气体消毒医疗用

2006-12-08

现行

KS P 6116(2016 Confirm)

의료용 소형 산화에틸렌 가스 멸균기
环氧乙烷气体消毒医疗用（小尺寸）

2006-12-08

现行

KS P 6116

의료용 소형 산화에틸렌 가스 멸균기
医用环氧乙烷气体灭菌器（小型）

2021-12-28

现行

JIS T 7325-1989

Ethylene oxide gas sterilizers for medical use (small size)
医用环氧乙烷气体灭菌器（小型）

1989-01-01

现行

YY/T 0822-2011

灭菌用环氧乙烷液化气体
Ethylene oxide liquefied gas for sterilization

2011-12-31

现行

AAMI TIR14-2016(R2020)

Contract sterilization using ethylene oxide
环氧乙烷合同灭菌

2016-06-05

现行

BS EN 1422-2014

Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
医用消毒器 环氧乙烷灭菌器 要求和试验方法

2014-05-31

现行

UNE-EN 1422-1998+A1-2009

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
医用灭菌器.环氧乙烷灭菌器.要求和试验方法

2009-09-09

现行

GOST R 57623-2017

Стерилизаторы для медицинских целей. Стерилизаторы на основе этиленоксида. Требования и методы испытаний
杀菌剂用于医疗用途 环氧乙烷灭菌器要求和测试方法

现行

CAN/CSA Z314.5-88

Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
环氧乙烷工艺对医疗器械的工业灭菌

1988-04-01

现行

YY/T 1403-2017

环氧乙烷分包灭菌的要求
Requirements of contract sterilization using ethylene oxide

2017-03-28

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

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

AAMI ST24-1999/(R)2018

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
用于医疗设施的自动、通用环氧乙烷消毒器和环氧乙烷消毒源

2009-08-14

现行

BS PD 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
医疗器械的消毒 使用参数释放的环氧乙烷灭菌过程的验证和常规处理要求指南

2020-09-16

现行

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
医疗器械的灭菌 - 使用参数释放对环氧乙烷灭菌过程的验证和常规加工要求的指导

2020-09-15

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

KS P ISO 10993-7

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

2017-12-29

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