The integrity of medical device packaging plays a critical role in patient safety. 

This is particularly true for devices that are terminally sterilized - that is, sterilized after being sealed within their packaging. The packaging must serve multiple functions: it must allow for sterilization, maintain sterility until use, and enable aseptic presentation during application.

At the heart of this system is the sterile barrier system (SBS), the minimum packaging required to achieve those functions. Often in the form of pouches or bags, SBSs are partially pre-assembled and completed through sealing or final closure before sterilization. In addition, a layer of protective packaging surrounds the SBS to prevent physical damage, forming a complete packaging system for terminally sterilized devices.

The packaging system must reliably ensure that medical devices remain sterile and undamaged from manufacturing through to the point of use. This requires rigorous control over manufacturing, packing, and sterilization processes - processes guided by two essential standards that were updated in 2023 to reflect evolving best practices.

To discover more about how standards are supporting medical device manufacturers in bringing safe and compliant products to market, visit our Medical Devices topic page. 

BS EN ISO 11607-1: Requirements for materials and design of sterile barrier systems

BS EN ISO 11607-1:2019+A1:2023 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems is the first. It specifies requirements and test methods for 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.

This document considers a wide range of potential materials, medical devices, packaging system designs and sterilization methods. The specific nature of the medical device, the intended sterilization method or methods, the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials. 

The standard can be used by suppliers of materials or of preformed sterile barrier systems, as well as by medical device manufacturers and healthcare facilities. 

BS EN ISO 11607-2: Validation requirements for forming, sealing and assembly processes

Meanwhile, BS EN ISO 11607-2:2019+A1:2023 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include the forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

The development and validation of packaging processes are crucial to ensuring that the integrity of the sterile barrier system is maintained, and that the device remains sterile under documented storage and transport conditions until the system is opened. 

Essentially BS EN ISO 11607-2:2019+A1:2023 provides a framework of activities and requirements that will develop and validate the process that’s used to assemble the packaging system. It can be used wherever medical devices are packaged and sterilized.

A focus on risk management

A significant enhancement in the 2023 amendments is the extended emphasis on risk management. Both standards now include a newly introduced annex specifically dedicated to risk considerations. This supports more comprehensive evaluation and mitigation of risks throughout packaging design, development, and validation stages.

The inclusion of risk management ensures the standards remain aligned with modern regulatory expectations, such as those outlined in the EU Medical Device Regulation (MDR), and reinforces the critical role of packaging in maintaining sterility and, ultimately, protecting patient health.

Ensure your packaging processes meet the latest international requirements. Purchase the updated BS EN ISO 11607-1 and BS EN ISO 11607-2 standards today to access the full guidance on materials, system design, and process validation.

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