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

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

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

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

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

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

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

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

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

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

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

2004-05-24

Change summary for 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
ISO 11135:2014《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》的变更摘要

2016-08-09

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

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

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

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
修订附件E 单批次释放

2018-10-15

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)
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（采用ISO 11135:2014 第二版 2014-07-15）

2015-11-01