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prEN 868-10

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

Số trang: 13
Ngày phát hành: 2009-01-00

Liên hệ
This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e. g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in this part of EN 868 are intended for single use only.
Số hiệu tiêu chuẩn
prEN 868-10
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Ngày phát hành
2009-01-00
Trạng thái
Hết hiệu lực
Tiêu chuẩn tương đương
Tiêu chuẩn liên quan
Thay thế cho
prEN 868-10 (2007-08)
Packaging materials for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-10
Ngày phát hành 2007-08-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
Thay thế bằng
EN 868-10 (2009-05)
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Số hiệu tiêu chuẩn EN 868-10
Ngày phát hành 2009-05-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
Lịch sử ban hành
EN 868-10 (2009-05)
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Số hiệu tiêu chuẩn EN 868-10
Ngày phát hành 2009-05-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-10 (2009-01)
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-10
Ngày phát hành 2009-01-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-10 (2007-08)
Packaging materials for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-10
Ngày phát hành 2007-08-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
Từ khóa
Adhesive * Adhesive film * Adhesives * Applications * Bag foil * Bags * Coated * Flexible pipes * Flexible plastics tube packaging * Heat-sealing materials * Hygiene * Inspection * Laminated foils * Lids * Marking * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Non-woven fabrics * Packages * Packages containers * Packaging material * Packaging tests * Plastics * Polyolefins * Production * Products * Safety * Safety requirements * Specification (approval) * Sterilization (birth control) * Sterilization (hygiene) * Sterilized goods * Sterilizers * Storage * Testing * Transparent sterilizing packing * Transport packing * Validation * Hoses * Bearings * Implementation * Use
Số trang
13