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国际标准
EN ISO 11135-2014 欧盟标准
作者：未知发布时间2025-04-14
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) - Determination of lethal
rate of the sterilization process - Biological
indicator/bioburden approach
Annex B (normative) - Conservative determination
of lethal rate of the sterilization process -
Overkill approach
Annex C (informative) - Temperature sensors, RH
sensors and biological indicator numbers
Annex D (informative) - Guidance on the application
of the normative requirements
Annex E (normative) - Single Lot Release
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of Directive 93/42/EEC
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) - Determination of lethal
rate of the sterilization process - Biological
indicator/bioburden approach
Annex B (normative) - Conservative determination
of lethal rate of the sterilization process -
Overkill approach
Annex C (informative) - Temperature sensors, RH
sensors and biological indicator numbers
Annex D (informative) - Guidance on the application
of the normative requirements
Annex E (normative) - Single Lot Release
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of Directive 93/42/EEC
标准简介：Defines requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and recognizes the similarities and differences between the two applications.
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