AAMI ISO 11607:2000 pdf download – Packaging for terminally sterilized medical devices
1.1 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 (see clause 6).
1.2 This International Standard outlines principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices (see clause 7). 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.
1.3 This International Standard specifies requirements for essential criteria used to evaluate the performance of packages for sterile medical devices (see clause 7). 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.
1.4 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.
1.5 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.
5.2.1.3 Determination of suitability for the intended purpose shall include consideration of material variations that will occur during normal routine supply. Where the product is enclosed by multiple wrappings, different limits on material properties may be set for inner and outer layers of packaging. Determination of suitability may be carried out concurrently with validation of the sterilization process(es) to be used. Testing of materials should assess the effect that the random variation of essential attributes can have on the performance of the material (e.g., thickness and/or pore size of porous materials).
5.2.1.4 Regarding the sterilization process specified, it shall be demonstrated and documented that the packaging material and/or system is suitable for use in the sterilization process for which it is intended by the producer of the packaging material and/or system (e.g., for ethylene oxide sterilization, this would include permeability to ethylene oxide gas, water vapor, and air). This shall include a demonstration that packaging materials and/or systems have, when necessary, sufficient permeance to air and the sterilant in order to permit the attainment of the required conditions for sterilization and to permit removal of sterilant after sterilization when assembled into a specified form for loading into the sterilizer. In addition, the physical properties of the material shall not be adversely affected over time by the sterilization process. NOTE—If compliance with EN 868-1 is desired, sterilization compatibility should be determined using a sterilizer designed, constructed, and operated in accordance with the requirements of the relevant European Standard (EN 285, EN 550, EN 552, EN 554, EN 1 422). Efforts are under way to harmonize these European Standards with International Standards.