Page 207 - Biomedical Engineering and Design Handbook Volume 2, Applications

186 MEDICAL DEVICE DESIGN

packaging operations. There must be a documented process validation program that demonstrates the
efficacy and reproducibility of all sterilization and packaging processes to ensure the package
integrity at the point of end use.
Finally, the new ISO standard provides a series of recommended tests and criteria to evaluate the
performance of the complete package under all of the stresses and hazards inherent in the packaging
and distribution process. These tests are listed in Annex B of the standard and include, but are not
limited to, the following types:
• Internal pressure
• Dye penetration
• Gas sensing
• Vacuum leak
• Seal strength
• Transportation simulation
• Accelerated aging
• Microbial barrier
For more interpretive information regarding the ISO 11607 standard, the AAMI Committee has
published a Technical Information Report (TIR) entitled; AAMI TIR-22:2007, Guidance for
ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices—Part 1 and Part 2:
2006. The scope of this document is to provide guidance on the application of ANSI/AAMI/ISO
11607 standard within the regulatory framework of the FDA that exists at the time of the publication
of the document. The TIR22 is a guidance document and should be used in conjunction with the
ANSI/AAMI/ISO 11607 standard. Another guidance document available to help medical device man-
ufacturers become compliant to ISO 11607 includes a publication by DuPont entitled; “DuPont Tyvek
Compliance to ISO 11607-1:2006.” It can be found at (www.MedicalPackaging.DuPont.com).
EN 868 Part 1. This European standard, entitled Packaging Materials and Systems for Medical
Devices Which Are to Be Sterilized: General Requirements and Test Methods, provides detailed guid-
ance on meeting the requirements of the MDD. It includes more detail on the selection and valida-
tion of packaging materials than does Clause 4 of the ISO 11607 standard. However, there are some
differences, and both standards must be considered when evaluating the packaging system for com-
pliance to the FDA and MDD regulations.
Standards within the EN 868 series fall into two distinct categories—horizontal and vertical. The
EN 868 Part 1 is a horizontal standard since it specifies the requirements for a broad range of pack-
aging materials, types, and designs. The requirements are essentially the same as ISO 11607, Part 1;
however, the ISO document also includes requirements for package forming and final package vali-
dation as described in Part 2. If you comply with the ISO 11607 Part 1, you will comply with EN
868, Part 1 since the documents have been harmonized as of the revisions to ISO 11607 in 2006.
Vertical standards within the 868 series include detailed requirements for individual materials or
specific package types or medical device products. These standards are designated as Parts 2 through
10. They specify limits for material properties for
• Sterilization wraps (Part 2)
• Paper for use in the manufacture of paper bags, pouches, and reels (Parts 3, 4, 5)
• Paper for the manufacture of packs for medical use for sterilization by ethylene oxide EtO or irra-
diation (Part 6)
• Adhesive-coated paper for the manufacture of heat-sealable packs for medical use for steriliza-
tion by EtO or irradiation (Part 7)
• Reusable sterilization containers for steam sterilization conforming to EN 285 (Part 8)
• Uncoated nonwoven polyolefin materials for use in the manufacture of heat-sealable pouches,
reels, and lids (Part 9)