现行

BS EN ISO 11138-2-2017

Sterilization of health care products. Biological indicators-Biological indicators for ethylene oxide sterilization processes
医疗保健产品的消毒 生物指标

2017-04-30

现行

GOST ISO 11138-2-2012

Стерилизация медицинской продукции. Биологические индикаторы. Часть 2. Биологические индикаторы для стерилизации оксидом этилена
保健产品的灭菌 生物指标 环氧乙烷灭菌生物指标

2012-05-24

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

KS P ISO 11138-2

의료제품의 멸균 — 생물학적 표시기 — 제2부: 산화에틸렌 멸균 공정에 대한 생물학적 표시기
保健产品的灭菌 - 生物指标 - 第2部分:环氧乙烷灭菌过程的生物学指标

2018-11-05

现行

GB 18281.2-2015

医疗保健产品灭菌　生物指示物　第2部分：环氧乙烷灭菌用生物指示物
Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes

2015-12-10

现行

KS P ISO 11138-2

의료제품의 멸균 — 생물학적 표시기 — 제2부: 산화에틸렌 멸균 공정을 위한 생물학적 표시기
保健品灭菌生物指示剂第2部分:环氧乙烷灭菌过程的生物指示剂

2023-12-28

现行

ISO 11138-2-2017

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
保健产品的灭菌 - 生物指标 - 第2部分:环氧乙烷灭菌过程的生物学指标

2017-03-03

现行

AAMI/ISO 11138-2-2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
医疗保健产品的灭菌.生物指示剂.第2部分:环氧乙烷灭菌过程用生物指示剂

2017-08-01

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

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

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

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

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)
医疗保健产品的灭菌环氧乙烷第2部分:ISO 11135-1的应用指南

2009-09-02

现行

AAMI TIR37-2013

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
保健品灭菌生物制品和组织制品灭菌辐射指南

2013-12-30

现行

AAMI ST41-2008/(R)2018

Ethylene oxide sterilization in health care facilities: Safety and effectiveness (Includes Erratum, 2010)
医疗设施中的环氧乙烷灭菌:安全性和有效性（包括勘误表 2010年）

2008-07-31

现行

ISO/TS 5111-2022

Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
卫生保健产品用消毒器、消毒器和清洗消毒器的水质指南

2022-12-19

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

AAMI ST67-2019

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
医疗保健产品的灭菌.标签为“无菌”的产品选择无菌保证水平（SAL）的要求和指南

2019-07-29