ONORM EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

This document specifies requirements for the information provided by the manufacturer for the preparation of critical and semicritic medical devices (that is a medical device, which has contact with sterile body areas, or a medical device, which has contact with mucosa or morbidly changed skin) or medical devices that require sterilization, to provide. This includes information on preparation before using or reuse of the medical device. No processing instructions are defined in this document. This document sets requirements instead to support medical device manufacturers in providing detailed processing instructions that, if applicable, comprise the following activities: (a) pretreatment at the resort; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) control and maintenance; g) packaging; h) sterilization; i) storage; j) Transport. This document concludes the preparation of the following: - uncritical medical devices, provided that they are not intended for sterilization, - textiles for use in patient cover systems or surgical clothing, - medical devices specified by the manufacturer only for single use and ready to use.