This part of EN 868 provides test methods and values for uncoated nonwoven materials of polyolefines 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 or 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
EN 868-9
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
Ngày phát hành
2009-05-00
Tiêu chuẩn tương đương
DIN EN 868-9 (2009-09), IDT * BS EN 868-9 (2009-10-31), IDT * NF S98-051-9 (2009-09-01), IDT * SN EN 868-9 (2009-09), IDT * OENORM EN 868-9 (2009-09-15), IDT * PN-EN 868-9 (2009-06-26), IDT * SS-EN 868-9 (2009-05-28), IDT * UNE-EN 868-9 (2009-12-02), IDT * UNI EN 868-9:2009 (2009-08-26), IDT * STN EN 868-9 (2009-11-01), IDT * CSN EN 868-9 (2009-12-01), IDT * DS/EN 868-9 (2009-08-30), IDT * NEN-EN 868-9:2009 en (2009-06-01), IDT * SANS 50868-9:2010 (2010-11-10), IDT * SFS-EN 868-9:en (2009-10-30), IDT
Tiêu chuẩn liên quan
ISO 8601 (2004-12) * ASTM D 2724 (1987) * EN 20811 (1992-06) * EN 21974 (1994-06) * EN ISO 536 (1996-06) * EN ISO 1924-2 (2008-12) * EN ISO 2758 (2003-07) * EN ISO 11607-1 (2006-04) * ISO 5636-3 (1992-09) * ISO 6588-2 (2005-05)
Từ khóa
Applications * Bag foil * Bags * Disposable * Equipment for single use * 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 * 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 * Disposables * Bearings * Implementation * Use