SO 17664-2004 Sterilization of medical devices -Information to be provided by the manufacturer for the processing of resterilizable medical devices
Contents Page
Foreword ....................................................................................................................................v
Introduction.................................................................................................................................vi
1 Scope.......................................................................................................................................1
2 Terms and definitions...................................................................................................................1
3 Information to be provided by the medical device manufacturer ....................................................3
3.1 Reprocessing instructions...........................................................................................................3
3.2 Limitations and restrictions on reprocessing...................................................................................3
3.3 Preparation at the point of use prior to processing ..........................................................................3
3.4 Preparation before cleaning........................................................................................................4
3.5 Cleaning ................................................................................................................................4
3.6 Disinfection.............................................................................................................................4
3.7 Drying ...................................................................................................................................5
3.8 Inspection, maintenance and testing.............................................................................................5
3.9 Packaging................................................................................................................................6
3.10 Sterilization............................................................................................................................6
3.11 Storage .................................................................................................................................6
4 Presentation of the information.......................................................................................................6
5 Validation of the reprocessing information provided ........................................................................7
6 Risk analysis...............................................................................................................................7
Annex A (informative) Commonly utilized reprocessing methods...............................................................8
A.1 General ...................................................................................................................................8
A.2 Matrix for identifying methods of processing....................................................................................9
Annex B (informative) An example of reprocessing instructions for reusable medical devices .............13
Bibliography..................................................................................................................................18
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