The EN 868-5 standard, which is a European standard, describes the requirements and test methods for sealable bags and reels made of porous materials and suitable plastic film conforming to the other parts of this standard. It is used as packaging systems that aim to protect the sterility of the devices up to the point of use.
For any material, preformed sterile barrier system, the requirements of EN ISO 11607-1 apply. The EN 868-5 standard only describes the performance requirements and test methods specific to the products covered by this standard, but does not add or replace the general requirements in the EN ISO 11607-1 standard. Materials covered by the EN 868-5 standard are for single use only.
If the manufacturer uses additional materials within the sterile barrier system, for example, inner wrap, gauges, packing lists, mats, instrument organizer sets or tray liners, other requirements may apply, including determining the acceptability of these materials during later validation activities.
Porous material must comply with other parts of this standard. If the intended sterilization method is irradiation only, wet strength properties and air permeability requirements do not apply for porous materials.
Plastic film is a composite consisting of two or more layers. When tested after sterilization as intended in the standard annex (Annex B), the bond between the plastics should not separate or become cloudy. When tested according to Annex C, it should not contain pinholes. When inspected under transmitted light (daylight or good artificial light) with normal or corrected vision without aiding, the plastic film should be free of foreign matter and other defects that would adversely affect the requirements. The plastic film should seal porous material under the specified conditions.
Among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors, our organization, with its trained and expert staff and advanced technological equipment, is made of porous materials used in the packaging of sterilized medical devices and plastic film production, within the scope of EN 868-5 standard. It also provides testing services for sealed bags and reels.
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