EN ISO 17664:2017

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified
  in the information provided by the medical
  device manufacturer
5 Risk analysis
6 Information to be provided by the medical
  device manufacturer
7 Presentation of the information
Annex A (informative) - Commonly utilized processing
        methods
Annex B (informative) - Example of processing instructions
        for reusable medical devices
Annex C (informative) - Classification of medical devices
Annex D (informative) - Additional guidance on information
        to be provided by the medical device manufacturer
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on medical devices

ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.