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Contact : Mr. D. L. Pandya
Classic Computer Services
B-4, Mandir Appt., Opp. P & T Colony, Jodhpur Char Rasta, Satellite Road, Ahmedabad-380 015. India.
Phone : +91 79 26740611 Telefax : +91 79 26754867
M : +91 9825457563
E-mail : mpds00@vsnl.com / dlpandya@gmail.com

Validation needs for packages of medical devices

According to the World Health Organization (WHO), healthcare-associated infections (HAIs) are the most frequent adverse event in the delivery of healthcare services worldwide, affecting hundreds of millions of patients each year. Ensuring the sterility of medical devices is an important tactic in the overall effort to reduce the rate of infections in hospitals and other healthcare settings.

Effective packaging and packaging materials are essential to help preserve the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental exposure, or be compromised through normal handling encountered during storage and transportation. As a result, rigorous testing of packaging systems used with medical devices is mandatory in most major jurisdictions around the world.

Regulators in the EU, the U.S. and other major healthcare markets have implemented strict requirements for packaging systems and packaging materials used to preserve the sterility of medical devices, protect their functionality and retain their biological safety. In the EU, medical device directives and regulations mandate that medical device packaging materials and systems conform with the requirements of the ISO 11607 series of standards, Packaging for terminally sterilized medical devices. And in the U.S., the FDA accepts evidence of compliance with ISO 11607 in support of 510(k) applications for the approval and registration of medical devices.

In this UL presentation, we’ll discuss the requirements and validation testing methods applicable to packaging systems and/or materials used in conjunction with sterile medical devices. Beginning with a review of the importance of packaging validation for medical devices, the presentation then presents a summary of ISO 11607, the standard for packaging materials used for sterilized medical devices, and provides details on validation testing as prescribed in the standard. The presentation concludes with some recommendations for manufacturers on the selection and evaluation of suitable packaging and packaging materials for medical devices.