This standard specifies requirements for the quality of the preparation, performance and documentation of the validation of manual cleaning and manual chemical immersion disinfection procedures and mechanical cleaning procedures as well as and mechanical chemical and thermal disinfection processes. The requirements regarding the quality of the results of the manual or mechanical processing (cleaned, disinfected, functional product) are identical. It applies to reprocessable non-critical, semi-critical and critical medical devices used in health care facilities for which validated cleaning and disinfection procedures are required. NOTE Requirements for validation of manual procedures for cleaning and disinfection of thermolabile endoscopes may differ from this standard. In addition to installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), this document also deals with requalification without special and for special reasons. This document applies to cleaning and disinfection procedures according to DIN EN ISO 15883-2 and DIN EN ISO 15883-4. This document is to be used together with DIN EN ISO 15883-1 and DIN EN ISO 15883-5. Requirements for the processing steps following the cleaning and disinfection process as well as for the given conditions (e. g. packaging, sterilization) are not subject of this standard. This document does not apply to the activities to be carried out by manufacturers of medical devices intended for reprocessing.