Reprocessing of health care products – information to be provided by the medical device manufacturer for the reprocessing of medical devices
EN ISO 17664 specifies requirements for the information to be provided by the manufacturer for the reprocessing of a medical device requiring cleaning and subsequent disinfection and / or sterilization. They are designed to ensure that the product is safe and effective for its intended use.
This includes reprocessing information before the application or re-use of the medical device.
Testing and evaluation of information to be provided by the manufacturer Instructions for the reprocessing of resterilizable medical devices (EN ISO 17664) include:
♦ initial treatment at the place of use ♦ preparation before cleaning ♦ cleaning ♦ disinfection ♦ drying ♦ inspection and maintenance ♦ packaging ♦ sterilization ♦ storage ♦ transport ♦
HygCen uses the respective coordinated procedures in the type tests, including relevant risk analyzes, to check whether the manufacturer's reprocessing instructions reproducibly result in a hygienically re-usable medical device, thus fulfilling the requirements of EN ISO 17664 and the Medical Devices Directive.
HygCen Austria GmbH
Accredited Testing Laboratory and Inspection Body for Hygiene and Medical Devices