EN ISO 25424:2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
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) - Process definition based on
        inactivation of reference microorganisms and
        knowledge of bioburden on product items to
        be sterilized
Annex B (normative) - Process definition based on
        inactivation of reference microorganisms
Annex C (informative) - Guidance on application of
        this European Standard
Annex D (informative) - Environmental aspects regarding
        development, validation and routine control of Low
        Temperature Steam and Formaldehyde processes
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on Active Implantable
         Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 98/79/EC on in vitro diagnostic medical
         devices

ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.