This Part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868-3, -6, -7, -9 or -10 and plastic film complying with clause 4 of this Draft European standard. This Part of EN 868 introduces no additional requirements to the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Sealable pouches and reels specified in this part of EN 868 are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of sealable pouches and reels as preformed sterile barrier systems enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened. NOTE Applicable sterilization methods are specified by the manufacturer.
Số hiệu tiêu chuẩn
prEN 868-5
Tên tiêu chuẩn
Packaging materials for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Ngày phát hành
2007-08-00
Tiêu chuẩn tương đương
DIN EN 868-5 (2007-10), IDT * 07/30166933 DC (2007-08-15), IDT * S98-051-5PR, IDT * OENORM EN 868-5 (2007-10-01), IDT
Từ khóa
Applications * Bags * Definitions * Dimensions * Flexible pipes * Flexible plastics tube packaging * Goods * Heat-sealing * Heat-sealing materials * Hygiene * Inspection * Laminated foils * Marking * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Packages * Packaging material * Packaging tests * Paper * Paper bags * Plastics * Products * Safety * Safety requirements * Sequence of operations * Specification (approval) * Sterilization (birth control) * Sterilization (hygiene) * Sterilization papers * Sterilized goods * Sterilizers * Storage * Testing * Tolerances (measurement) * Transparent packages * Transparent sterilizing packing * Transport packing * Use * Validation * Hoses * Bearings * Implementation