SN EN 15424 : 2007

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

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