This part of EN 868 provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. 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 868-7
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Ngày phát hành
2009-05-00
Tiêu chuẩn tương đương
DIN EN 868-7 (2009-09), IDT * BS EN 868-7 (2009-10-31), IDT * NF S98-051-7 (2009-09-01), IDT * SN EN 868-7 (2009-09), IDT * OENORM EN 868-7 (2009-09-15), IDT * PN-EN 868-7 (2009-06-26), IDT * SS-EN 868-7 (2009-05-28), IDT * UNE-EN 868-7 (2009-12-02), IDT * UNI EN 868-7:2009 (2009-08-26), IDT * STN EN 868-7 (2009-11-01), IDT * CSN EN 868-7 (2009-12-01), IDT * DS/EN 868-7 (2009-08-30), IDT * NEN-EN 868-7:2009 en (2009-06-01), IDT * SANS 50868-7:2010 (2010-11-10), IDT * SFS-EN 868-7:en (2009-10-30), IDT
Tiêu chuẩn liên quan
ISO 8601 (2004-12) * EN 20187 (1993-09) * EN 20535 (1994-06) * 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 3689 (1983-09) * ISO 3781 (1983-06) * ISO 5636-3 (1992-09) * ISO 6588-2 (2005-05) * ISO 9197 (2006-04) * ISO 9198 (2001-06)
Từ khóa
Adhesive paper * Adhesive-bonded joints * Adhesives * Applications * Coated paper * Disposable * Equipment for single use * Ethylene oxide * Heat-sealing materials * Hygiene * Inspection * Low temperatures * Marking * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Packages * Packaging * Packaging material * Packaging tests * Paper * Products * Safety * Safety requirements * Specification (approval) * Sterilization (birth control) * Sterilization (hygiene) * Sterilized goods * Sterilizers * Storage * Testing * Transport packing * Validation * Disposables * Bearings * Implementation * Use