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

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

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/ISO 11135-2014

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

2015-07-27

现行

KS P ISO 11135

의료제품의 멸균 — 산화에틸렌 — 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求

2018-11-05

现行

BS 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
医疗产品的消毒 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求

2020-01-15

现行

KS P ISO 11135

의료제품의 멸균 ─ 산화에틸렌 ─ 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健品灭菌─ 环氧乙烷─ 医疗器械灭菌过程的开发、验证和常规控制要求

2022-12-28

现行

GOST ISO 11135-2017

Стерилизация медицинской продукции. Этиленоксид. Требования к разработке, валидации и текущему управлению процессом стерилизации медицинских изделий
保健产品的灭菌 环氧乙烷 医疗器械灭菌过程的开发 验证和常规控制的要求

2017-06-01

现行

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
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求

2014-07-07

现行

KS P ISO 11135

의료제품의 멸균 ─ 산화에틸렌 ─ 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健品灭菌─ 环氧乙烷─ 医疗器械灭菌过程的开发、验证和常规控制要求

2022-12-28

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

DIN EN 1422-2014-08

Sterilisatoren fr medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prfverfahren
医用灭菌器.环氧乙烷灭菌器.要求和试验方法

2014-08-01

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 6115

의료용 산화에틸렌 가스 멸균기
医用环氧乙烷气体灭菌器

2021-12-28

现行

KS P 6115

의료용 산화에틸렌 가스 멸균기
医用环氧乙烷气体灭菌器

2021-12-28

现行

AAMI TIR56-2013/(R)2020

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
医疗器械灭菌用柔性袋系统环氧乙烷灭菌过程的开发、验证和常规控制指南

2013-12-27