ONORM EN ISO 17664:2018

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

This document defines requirements for the information which provide are by the manufacturer for the processing of a medical device which requires cleaning and subsequent disinfection or sterilization, to ensure that the product for its intended use is safe and effective. This includes processing information prior to the use or re-use of the device. The provisions in this document are applicable for medical products, for an invasive or other direct or indirect contact with the patient are provided. No reprocessing instructions are defined in this document. This document, instead, lays down requirements to help medical device manufacturers, to provide, if applicable, the following activities will include detailed instructions for reuse: a) initial treatment at the destination; b) preparation before cleaning; (c) cleaning; (d) disinfection; (e) T...