国内标准
国外标准
UNI EN 1422-2014 消毒器用于医疗目的 - 环氧乙烷灭菌器 - 要求和试验方法
标准编号：UNI EN 1422-2014
中文标准名称：消毒器用于医疗目的 - 环氧乙烷灭菌器 - 要求和试验方法
英文标准名称：Sterilizers For Medical Purposes - Ethylene Oxide Sterilizers - Requirements And Test Methods
标准状态：现行有效
代替标准号：UNI EN 1422:2009
采用国际标准编号：BS EN 1422 Identical
DIN EN 1422 Identical
EN 1422 Iden
DIN EN 1422 Identical
EN 1422 Iden
语言：意大利语, 中文版, 英文版
实施日期：2014-08-27
标准类别：意大利UNIUNI
标准目录：Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test instrumentation
Annex B (normative) - Leak test cycle
Annex C (normative) - Sterilizer chamber profile testing
Annex D (normative) - Microbiological test for EO sterilizers
Annex E (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test instrumentation
Annex B (normative) - Leak test cycle
Annex C (normative) - Sterilizer chamber profile testing
Annex D (normative) - Microbiological test for EO sterilizers
Annex E (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography
标准简介：Defines the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
文件格式：纸质版或者PDF电子版（用Acrobat Reader打开）或Word版本doc格式
文件大小：860 KB
添加时间：2015/01/27
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