The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a product that performs efficiently, safely and effectively in the hands of the user.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation.
BS EN ISO 11607-1 specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs and sterilization methods. The standard describes the validation requirements for forming, sealing and assembly processes. BS EN ISO 11607-1 specifies general requirements for all packaging materials whereas BS EN 868 Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of BS EN ISO 11607 were designed to meet the Essential Requirements of the European Medical Device Directives.
European standards that provide requirements for particular materials and preformed sterile barrier systems are available and known as the BS EN 868 series. BS EN ISO 11607-1 has been developed as a means to show compliance with the relevant Essential Requirements of the European Directives concerning medical devices. Compliance with EN 868 Parts 2 to 10 can be used to demonstrate compliance with one or more of the requirements of BS EN ISO 11607-1..
The specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials. One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe, and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a result, the term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.
BS EN ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. An overview of sterile barrier systems can be found in Annex A.
It is applicable to industry, health care facilities and wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. Nor does it describe a quality assurance system for control of all stages of manufacture.
BS EN ISO 11607-1:2006 supersedes BS EN 868-1:1997, which has been withdrawn.
