ISO 17664:2017

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices ISO 17664:2017

Publication date:   Oct 25, 2017

Scope

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.