EN 15424:2007

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 qualification
        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 considerations
      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 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

1.1Inclusions1.1.1This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.NOTEAlthough the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2This European Standard 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. (See EN ISO 14937:2000, Table E.1)1.1.3This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.1.2Exclusions1.2.1Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.1.2.2This standard does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1. 1.2.3This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTEAttention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appro