Page 208 - Biomedical Engineering and Design Handbook Volume 2, Applications

STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 187

• Adhesive-coated nonwoven polyolefin materials for use in the manufacture of heat-sealable
pouches, reels, and lids (Part 10)
The “Essential Requirements” of the MDD can be effectively met by complying with the require-
ments of the ISO 11607 and EN 868, Part 1 standards.

CE Mark. A CE Mark can be affixed to the medical device when all of the essential requirements
of the MDD and other directives, as appropriate, are met. The declaration of conformity that con-
tains the documented evidence that all requirements have been met achieves this.

7.3 FUNCTIONS OF A PACKAGE

The first step in designing and developing a package system for a medical device is obtaining all of
the design inputs. This task provides all of the critical attributes and requirements of the device
which could have an effect on the package design and performance. The design inputs also influence
the selection of materials appropriate for and compatible with the device. Packages are intended to
contain the product. However, for medical devices, there are other functions the package serves; it
provides protection, identification, process ability, ease of use, and special applications for device
use and presentation. A basic knowledge of the product’s use, dimensions, shape, special character-
istics (e.g., sharp edges, points, and fragility), distribution environment, application, and barrier
requirements are essential to selecting appropriate materials and designing the final package.

7.3.1 Protection
Protection of the device by the package may be provided in several different ways. Primarily, the
sterile medical device must be protected from the bacteria and microorganisms natural to the envi-
ronment. The package must provide a protective barrier from the environment but must also allow
the product to be terminally sterilized, be opened easily by medical professionals, and maintain
integrity until the point of end use. Materials must allow for the most efficient and effective steril-
ization method but not be degraded by that method. The package must also provide protection to the
product from the hardships of the distribution and handling environment. In addition, there cannot
be any damage to the package itself from shock or impacts associated with handling in shipment,
resulting in loss of seal integrity. Materials must be resistant to impacts and abrasion. The package
must be designed so as to prevent sharp objects from piercing the materials or damaging seals, by
eliminating movement of the device inside the package. In some applications, the product may be so
fragile that the package must have cushioning characteristics that prevent excess shock energy to be
transmitted to the device. Protection of the device over an extended shelf life is another function of
the package design requiring material stability over time.
Summarizing the protective features of a package for a sterile medical device, the package
must have
• Sterilizability: provide the ability to terminally sterilize the device by one or more methods with-
out degrading the material.
• Shelf life: ensure the stability of the material as a barrier throughout the life cycle of the
product.
• Environmental: provide barrier to moisture, air, bacteria, oxygen, light.
• Physical: provide dynamic protection, resist impacts and abrasion, and provide structural support.

The materials most commonly used for medical device packages today incorporate the charac-
teristics required for a protective package.