ANSI/AAMI TIR30:2011 states that one should expect a 3 log reduction in bioburden for the purposes of a cleaning validation. Are there any other standards or guidances that provide requirements (ideally EU)?
Any help or pointers would be greatly appreciated.
- ISO 17664:2004, Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices: this standards is harmonized in the EU (EN ISO 17664:2004)