ISO 11607 Packaging for Terminally Sterilized Medical Devices

Introduction to ISO 11607 

ISO 11607 is a standard designed to ensure that the packaging system provides adequate protection to the device during transportation and storage. Medical devices require protection during transportation and storage to ensure their functionality and safety. The packaging system plays a critical role in providing this protection, especially for terminally sterilized medical devices. ISO 11607 provides guidance for designing, validating, and maintaining packaging systems for these devices to ensure their integrity. MaTestLab is one of the leading testing service providers in the USA and Canada. We have a large network of testing laboratories in the USA.

ISO 11607 Test Method

The following are the steps involved in the packaging system validation process according to ISO 11607:

ISO 11607 Specimens

The terminally sterilized medical device is the specimen for packaging system validation according to ISO 11607. The packaging system should be designed and validated to protect the device during transportation and storage and maintain its sterility until the point of use.

ISO 11607 Results

The results of the packaging system validation demonstrate that the system maintains the device’s sterility and protects it during transportation and storage.

Tests related to ISO 11607

The methods related to ISO 11607 include:

ISO 11737-1:2018 – Sterilization of Health Care Products – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products

ISO 11607-2:2006 – Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes

ASTM D4169  Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11608 is a similar standard that provides guidance on the design and testing of devices that deliver drugs and medication. It provides guidance on the design and testing of devices that administer medication, ensuring that they meet user needs and deliver the correct dose of medication.