ISO 11607 Testing Standard for Medical Packaging

ISO 11607 is an internationally recognized standard for the testing of materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain the sterility of terminally sterilized medical devices until the point of use. 

It is widely used within the medical packaging industry and by any industry that supplies medical devices to patients in a healthcare environment. 

Why are medical packaging standards essential?

ISO 11607 is a set of rules and guidance on how to make sure that a medical product and its packaging will arrive in a safe and sterile condition. This sterility is essential for anyone manufacturing medical devices supporting surgery and for devices that offer internal administration of medicines or diagnosis.  

Medical packaging must be fit for purpose, ensuring that certain items remain sterile from the moment they leave the manufacturer to their eventual delivery into the hands of the end user. Rules like those set out by ISO 11607 minimize the risk of products becoming contaminated. 

What does ISO 11607 cover?

Tried and tested ISO 11607 procedures set the standard. They’re recognized in the United States by the Food and Drug Administration (FDA), across the European Union through the CE marking and in many other countries.  

Think of the ISO 11607 standard as a full guide to the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. Or to put it simply: they’re important whenever medical devices are contained within sterile barrier systems and are sterilized before hitting the supply chain. 

Understanding sterile barrier systems

A sterile barrier system, or SBS, is a packaging configuration designed to provide a microbial barrier and allows an aseptic presentation of the product unit at the point of use. To ensure that a sterile barrier system is in place, seal integrity and seal strength must be thoroughly tested to ISO 11607 standards.  

Testing medical packaging and SBS

The ISO 11607 standard is split into two distinct parts, covering the demands on packaging for terminally sterilized medical devices. 

• ISO 11607 1: Part one establishes the requirements and methods for testing the sterile barrier systems and packaging systems, to ensure they remain terminally sterilized from factory to end user. 
• ISO 11607 2: Part two sets out the process requirements on a manufacturer when creating a sterile barrier system for their medical devices. It includes what they should do to minimize any risk of contamination in the factory and through the supply chain.  

Medical packaging requirements and ISO 11607

ISO 11607 is a stringent standard and there are a variety of requirements to meet. The most important takeaway is that any medical packaging must keep a device sterile until the moment of use. The recipient must have absolute confidence that when such items are removed from medical packaging, they don’t pose any contamination health risks. In fact, there’s even guidance on how the device should be removed safely from the package! 

Medical packaging must withstand sterilization

ISO 11607 clearly states that the packaging must be able to withstand the sterilization process itself, without becoming damaged. 

In order for a product and package to be ‘terminally sterilized’ it often goes through a gas sterilization process. You typically find that ethylene oxide (EO) is used to sterilize medical devices. It’s a harsh gas that penetrates the packaging, so this must be taken into account. ISO 11607 demands that both the sterile barrier system – and protective packaging – must survive the sterilization process without defects, which can take the form of degradation and discoloration, for example. 

Medical packaging must maintain shelf-life integrity

ISO 11607 presents the processes that a manufacturer must follow to protect medical devices from typical damage they could incur through the supply chain and whilst in storage with a series of ‘real world’ testing procedures established to make sure that the package has the necessary shelf-life integrity.  

Comprehensive medical packaging testing

Everything from resistance to atmospheric pressure, compression and temperature fluctuation must be considered. When it comes to the testing requirements of ISO 11607, the medical device manufacturer must follow a sampling method that is based on sound statistical foundations. 

Put our ISO 11607 knowledge to the test

At Industrial Physics, we can help you to understand and exceed every requirement laid out in ISO 11607. We make custom built inspection machines for all aspects of package validation testing – everything from burst and creep testing through to pressure decay and bubble leak testing.  

If you’d like to talk through any aspect of the ISO 11607 standard process and learn how your company can meet every expectation,  just get in touch.