DIN EN 15424:2007-08

Foreword
Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality Management System Elements
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Control of non-conforming product
5 Sterilizing agent characterization
   5.1 General
   5.2 Sterilizing agent
   5.3 Microbicidal effectiveness
   5.4 Material effects
   5.5 Environmental considerations
6 Process and equipment characterization
   6.1 General
   6.2 Process
   6.3 Equipment
7 Product definition
8 Process definition
9 Validation
   9.1 General
   9.2 Installation qualification
        9.2.1 General
        9.2.2 Installation
        9.2.3 Equipment
   9.3 Operational qualification
   9.4 Performance
        9.4.1 General
        9.4.2 Performance qualification - physical
        9.4.3 Performance qualification - microbiological
        9.4.4 Performance qualification - desorption and drying
   9.5 Review and approval of validation
10 Routine monitoring and control
   10.1 General
   10.2 Biological indicators
   10.3 Chemical indicators
   10.4 Records
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 General
   12.2 Maintenance of equipment
   12.3 Requalification
   12.4 Assessment of change
Annex A (normative) Process definition based on inactivation
                     of reference microorganisms and knowledge
                     of bioburden on product items to be sterilized
    A.1 General
    A.2 Procedure
Annex B (normative) Process definition based on inactivation
                     of reference microorganisms
    B.1 General
         B.1.1 Overkill approach
         B.1.2 Penetration characteristics into medical devices
    B.2 Test procedure
         B.2.1 General
         B.2.2 Biological indicators
         B.2.3 Test systems
         B.2.4 Load configuration
         B.2.5 Testing
Annex C (informative) Guidance on application of this European
                      Standard
    C.1 Scope
    C.2 Normative references
    C.3 Terms and definitions
    C.4 Quality management system elements
    C.5 Sterilizing agent characterization
         C.5.1 Neutralization
         C.5.2 Studies of microbial inactivation
    C.6 Process and equipment characterization
    C.7 Product definition
         C.7.1 General
         C.7.2 Design considerations for medical devices
               intended for sterilization
         C.7.3 Packaging
    C.8 Process definition
         C.8.1 General
         C.8.2 Influence on product and packaging
         C.8.3 Determination of process effectiveness
    C.9 Validation
         C.9.1 General
         C.9.2 Installation qualification (IQ)
         C.9.3 Operational qualification (OQ)
         C.9.4 Performance qualification (PQ)
         C.9.5 Documentation and approval of validation
    C.10 Routine monitoring and control
    C.11 Product release from sterilization
         C.11.1 General
         C.11.2 Product release using biological indicators
         C.11.3 Parametric release
    C.12 Maintaining process effectiveness
         C.12.1 Change control
         C.12.2 Requalification
Annex D (informative) Environmental aspects regarding
                      development, validation and routine
                      control of Low Temperature Steam and
                      Formaldehyde processes
    D.1 General
    D.2 Formaldehyde (brief description)
    D.3 Environmental impact of formaldehyde
    D.4 Other environmental burdens
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of EU Directive 93/42/EEC Medical devices
Bibliography

Gives requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.