International Organization for Standardization (ISO) published revised standards on packaging for terminally sterilized medical devices. The creation of appropriate standards is crucial to achieve that the development, validation of packaging processes as well as the device components and the packaging system ‘’create sterile medical device that performs efficiently, safely and effectively… and ensure that sterile barrier system integrity is attained and will remain so until opened by the users… ’’.
Previous editions date from 2006 with amendments in 2014. The two newly updated standards are shortly presented below:
ISO 11607-1:2019 —Part 1: Requirements for materials, sterile barrier systems and packaging systems specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
However, the standard does not cover medical devices that are manufactured aseptically; it does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal. Please also note that additional requirements can be necessary for drug/device combinations.
ISO 11607-2:2019 — Part 2: Validation requirements for forming, sealing and assembly processes specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
Such as firstly presented ISO standard, ISO 11607-2:2019 equally does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations as well.
If you wish to know more about the revised standards, or how to comply with the regulatory requirements and obtain the CE marking for your device, Obelis experts will gladly assist you with over 30 years of experiences! Contact us here.
Ajda Mihelcic