Page 205 - Biomedical Engineering and Design Handbook Volume 2, Applications

184 MEDICAL DEVICE DESIGN

• 1990—Safe Medical Device Act (SMDA)
• 1997—Food and Drug Administration Modernization Act (FDAMA)
So, medical device manufacturers are subject to the provisions of the FDAMA and the GMP when doing
business in the United States. The regulations are published in 21 CFR (Code of Federal Regulation),
Part 820. The section dealing specifically with the requirements for packaging is Section 820.130. FDA
approves products for use through the investigational device exemption (IDE), premarket application
(PMA), and 510(k) processes. Additional information on the medical device approvals process can be
found at the following Web site: http://www.fda.gov/CDRH/devadvice/ide/approval.shtml. There may
be additional regulatory burdens when the device is being marketed outside of the United States. Some
of these regulations are discussed in Sec. 7.2.1.

7.2.1 International Regulations
International regulations play a significant role in the marketing and use of medical devices. The
European Union “Council Directive concerning medical devices” (MDD) is the European equivalent
of the FDA regulations. The MDD (93/42/EEC), also known as the “Medical Device Directive,” as
published in the EEC in 1993, (http://www.translate.com/multilingual_standard/MDD.pdf) lists the
essential requirements for devices and packages, and all medical devices sold on the European free
market must meet the specifics of this directive, which overrides all national regulations. The
“Essential Requirements” section for medical devices and packages is found in Annex I of the MDD.
General requirements for ensuring that characteristics of the medical device are not altered or
adversely affected during their intended use as a result of transport and storage are found in Sec. 5.
There are more specific requirements for infection and microbial contamination as it relates to pack-
aging in Sec. 8. It is incumbent on the medical device manufacturer to conform to all of the sections
of the “Essential Requirements,” not just the packaging requirements.
ISO 11607. An ISO standard approved in 1997 by the international community, and most recently
revised and republished in 2006, has become essential to the development and validation of a pack-
age system for a terminally sterilized medical device. Compliance with this standard and other
European standards ensures compliance with the packaging provisions of the MDD “Essential
Requirements.” The two-part ISO 11607 standard is entitled
• Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile
barrier systems, and packaging systems;
• Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming,
sealing, and assembly processes.
ISO 11607 is the foremost standard for validating packaging for terminally sterilized medical
devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept
sterile throughout all the elements and hazards generated by the manufacturing, shipping, and stor-
age environments.
What revisions Were Made to the ISO 11607 Standard Since 2004? The ISO 11607 standard
was revised to harmonize with the provisions of the EN 868-1 standard as discussed below. As a
result, the new ISO 11607-01 comprises two parts:

• Part 1: Materials and designs
• Part 2: Processes
A summary of the changes are as follows:

Terminology Many terms have been added or eliminated from the current standard, including:
The Definition of “medical device.” ISO 11607-01 includes some medical devices that were not pre-
viously covered by the old standard.