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revised, efforts should be made to harmonize the ISO and CEN documents.
CEN affirmed this approach by passing a resolution with the same strategy.
Both committees finished their respective standards, EN 868-1 [8] and ISO
11607, and were published in 1997 [17].
ISO TC198/WG7 began revising ISO 11607 immediately, with a goal
of identifying the differences between EN868-1 and ISO 11607. This was
a mechanism to show both working groups, ISO TC198/WG7 and CEN
TC102/WG4, that the two documents were in fact similar. The results of
this work were published as a revised ISO 11607 in 2003. Work began to
finally harmonize ISO 11607 and EN 868-1 even before the 2003 revision
was published. This effort resulted in the publication of EN ISO 11607-1
and EN ISO 11607-2 in 2006. EN 868-1 was withdrawn and a truly har-
monized global standard for medical packaging was created.
During this same time of ISO and EN standards development, and in
concert with the initiatives of the Flexible Packaging Association, ASTM
committee F2.0 began developing standardized test methods for evaluat-
ing medical packaging resulting in the development of over 10 new test
methods.
During the next revision of ISO 11607, ISO TC198/WG7 focused
on integrating the new requirements of the Medical Device Regulation
(MDR) [18] in Europe which made specific references to packaging of
sterile medical devices. To maintain compliance with the MDR, the ISO
TC198/WG7 working group has incorporated these requirements into
ISO 11607 which has been published in February 2019.

5.2 Technologies
5.2.1 Introduction

Combination products bring new challenges for the design and develop-
ment of packaging systems. A combination product involves a medical de-
vice and/or a pharmaceutical and/or a biologic.
The different types of combination products may require different packag-
ing solutions. Packaging needs to keep pace with the rapidly evolving technol-
ogies driven to develop innovative products that improves patient outcomes.
This product evolution along with changes to sterilization techniques and
regulatory pathways are challenging current packaging materials, designs, and
processes. These challenges require the packaging professional to be knowl-
edgeable across a wide range of, terminology, materials, designs, processing
techniques, sterilization modalities, and regulatory requirements [19–21].