ISO/TC 198/WG 7 - Packaging

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

This document specifies 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. It is applicable to industry, to health care facilities, and to 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 can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

This International Standard specifies the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities. This International Standard outlines principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices. Forming and sealing are considered to be the most critical processes. Other process operations that can affect the final package are addressed also. Guidelines are provided for the most common practices and techniques. This International Standard specifies essential criteria used to evaluate the performance of packages for sterile medical devices. The intent is to provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package used to protect device components during handling, distribution and storage. This International Standard does not cover all requirements for packaging for products manufactured aseptically; in such cases, additional requirements are necessary to ensure that the packaging and packaging process do not present a source of contamination of the product. This International Standard is not applicable to protocols for sampling plans or the number and duration of replicate runs. NOTE For the purposes of this International Standard, hospitals or other organizations that package medical devices are considered to be manufacturers.

Contains the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices whether produced industrially or in health care facilities. Provides guidelines for the most common practices and techniques for the final packaging. The purpose is, to provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package.