Ensuring the safety and effectiveness of medical devices throughout their lifecycle is paramount. ISO 17664-1:2021, published by the International Organization for Standardization (ISO), addresses a crucial aspect: the information exchange between medical device manufacturers and processors (hospitals or other facilities that reprocess devices).
What does it do?
Why is it important?
ISO 17664-1:2021 is a vital tool for both medical device manufacturers and healthcare processors. By following this standard, manufacturers can ensure their devices are reprocessed safely and effectively, while processors can gain the necessary knowledge to maintain the integrity and functionality of these critical medical tools. This collaborative effort leads to a safer and more efficient healthcare environment for everyone.
This document excludes processing of the following:
°°°°°° non-critical medical devices unless they are intended to be sterilized;
°°°°°° textile devices used in patient draping systems or surgical clothing;
°°°°°° medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE°°°°°° See ISO 17664-2:2021, Annex°E, for further guidance on the application of the ISO°17664 series to a medical device.