This guide complies with DIN EN ISO 17664:2004 „Sterilization of medical devices – Information to be provided by the manufacturer for the reprocessing of resterilizable medical devices“. The standard specifies two variants of sterilization instructions. The purpose is to provide the medical device manufacturer with assistance in preparing the instructions. We have prepared and edited the examples and created the necessary internal instructions and information. The pool of process descriptions, work instructions and evidence / forms is in accordance with the standard requirements.
Your advantage
This sample file can be used to minimize the time required to create standardized processing instructions. All data and templates are also available in digital form and can be easily modified for internal use.