Written by our experts, our blog provides updates on regulatory issues, upcoming changes to compendial test standards, and information about our participation with standard writing committees and organizations (AAMI, ASTM, AATB, ISO).
September 15, 2021
By: Alpa Patel and Lise Vanderkelen
ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be...
September 8, 2021
It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety...
September 1, 2021
Choosing a chemical disinfectant will depend on a combination of considerations with regards to the reprocessing instructions, location of the...
August 25, 2021
ISO17664:2017[1] notes that disinfection can be carried out concurrently with manual cleaning of a medical device but does not provide...
August 18, 2021
By: Lise Vanderkelen and Alpa Patel
The ISO 17664 series[1][2] as well as the FDA guidance for reprocessing medical devices in health care settings[3] specify that...
