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).
August 25, 2021
By: Alpa Patel and Lise Vanderkelen
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...
August 11, 2021
Acceptance criteria for disinfection validations that are outlined in AAMI TIR12:2020[1] specify that depending on the disinfection level either a...
July 30, 2021
Deciding which disinfection level applies to your non-critical device can be tricky. Non-critical devices are defined as devices that will...
July 28, 2021
ISO 17664[1] specifies that ”where drying is necessary, at least one verified drying method shall be specified.” FDA provides more...
