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STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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Published date: 12-01-2013
Publisher: Belgian Standards
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Quality system elements 4.1 General 4.2 Assignment of responsibilities 4.3 Documentation and records 4.4 Design control 4.5 Calibration5 Sterilizing agent characterization 5.1 General 5.2 Sterilizing agent 5.3 Microbicidal effectiveness 5.4 Material effects 5.5 Safety and the environment6 Process and equipment characterization 6.1 General 6.2 Process characterization 6.3 Equipment characterization7 Product definition8 Process definition9 Validation 9.1 General 9.2 Installation qualification 9.3 Operational qualification 9.4 Performance qualification 9.5 Review and approval of validation10 Routine monitoring and control11 Product release from sterilization12 Maintaining process effectiveness 12.1 General 12.2 Maintenance of equipment 12.3 Requalification 12.4 Assessment of changeAnnex A (normative) Factors to be considered in selection of microorganisms for demonstrating microbicidal effectivenessAnnex B (normative) Approach 1 - Process definition based on inactivation of the microbial population in its natural stateAnnex C (normative) Approach 2 - Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilizedAnnex D (normative) Approach 3 - Conservative process definition based on inactivation of reference microorganismsAnnex E (informative) Guidance on application of this International StandardAnnex ZA DeletedBibliography
Defines general requirement for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices.
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