The EN 868 standard, which is a European standard, consists of the following subsections under the main heading of "Packaging for finally sterilized medical devices":
The EN 868-1 standard describes the requirements and test methods for packaging materials and systems used for packaging medical devices to be sterilized, and for maintaining the sterility of the device. This standard was developed as a way of demonstrating compliance with the relevant European directives. Healthcare organisations, for example hospitals, are not covered by these directives if they do not offer medical devices to the market. However, such healthcare facilities can meet the same requirements as manufacturers. This standard does not apply to packaging materials and systems used for packaging aseptically produced products. However, this standard does not define a quality assurance system for the control of all stages of production. Attention should be paid to the standards of quality systems that control all production stages, including the sterilization process.
The EN 868-2 standard describes test methods and values for sterile barrier systems and packaging systems that are intended to maintain the sterility of finally sterilized medical devices up to the point of use.
EN 868-3 standard describes test methods and values for the production of paper bags (specified in EN 868-4 standard), sterile barrier systems, and finally, packaging systems intended to maintain the sterility of sterilized medical devices until the point of use .
In the EN 868-4 standard, test methods and values are provided for the paper bags produced from the paper specified in the EN 868-3 standard used as sterile barrier systems, and finally for packaging systems that aim to preserve the sterility of sterilized medical devices up to the point of use.
In the EN 868-5 standard, This document defines test methods and values for resealable bags and reels made of porous materials and plastic film conforming to part 2, in accordance with sections 3, 6, 7, 9, 10 or 4 of this standard. These sealable bags and reels are used sterile. These sealable bags and reels are used as sterile barrier systems and finally packaging systems aimed at preserving the sterility of sterilized medical devices up to the point of use.
The EN 868-6 standard describes test methods and values for paper used in the manufacture of preformed sterile barrier systems and packaging systems that are intended to maintain the sterility of finally sterilized medical devices up to the point of use.
In the EN 868-7 standard, test methods and values are explained for the sealed adhesive-coated paper made of paper in accordance with the EN 868-6 standard, which is used as sterile barrier systems and packaging systems aimed at preserving the sterility of medical devices that have been sterilized until the point of use. The materials specified in this section are intended to be used for ethylene oxide or irradiation sterilization.
The EN 868-8 standard defines test methods and values for reusable containers used as sterile barrier systems that aim to preserve the sterility of finally sterilized medical devices up to the point of use. These containers are designed for use in steam sterilizers conforming to EN 285 standard. The need for packaging material in the container is determined by the manufacturers and users.
The EN 868-9 standard describes test methods and values for non-woven materials of uncoated polyolefins used for sterile barrier systems and packaging systems intended to maintain the sterility of sterilized medical devices up to the point of use. The materials specified in this section are for single use only.
In the EN 868-10 standard, test methods and values are defined for the sealed adhesive coated non-woven materials of polyolefins, produced from non-woven fabrics in accordance with the EN 868-9 standard, used for sterile barrier systems and packaging systems aiming to preserve the sterility of medical devices that have been sterilized until the point of use. The materials specified in this section are for single use only.
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