Package Validations for Sterilized Medical Devices

At QTS, we adhere to ISO standard 11607, “Packaging for Terminally Sterilized Medical Devices,” which is an international standard that specifies the requirements for single-use materials and re-usable containers for packaging of terminally sterilized medical devices.

Through our rigorous package and seal validations, we ensure every package meets the requirements to protect medical devices by complying with ISO and ASTM standards.

For more information on validation guideline standards, check out our Quality page for a complete listing. Please contact us if you have further questions about package validation.

QTS Package Validation Services: Shelf Life Studies and Accelerated Aging (ASTM F1980) Transportation and Distribution Testing (ASTM D4169, ISTA1,2&3 series) Sterilization Validations