DIN EN ISO 17664-2
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 2: Unkritische Medizinprodukte (ISO 17664-2:2021); Deutsche Fassung EN ISO 17664-2:2023
Overview
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (namely, a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. The responsible national standardization committee is Working Committee NA 176-03-09 AA "Sterilisation und Aufbereitung von Medizinprodukten" "Sterilization and processing of medical devices" at DIN Standards Committee Health Technologies (NAGesuTech).
Document: references other documents
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204/WG 12 - Annex Z reviews
Responsible international committee
ISO/TC 198/WG 12 - Information for reprocessing of resterilizable devices