AAMI Products
ANSI/AAMI/ISO 11607-2:2019 (PDF)
Member Price: $80
Non-Member Price: $143
This standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
Date of Publication: 24 May 2019
Pages: 26
ISBN: 978-1-57020-720-4