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prEN 868-6

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

Số trang: 16
Ngày phát hành: 2009-01-00

Liên hệ
This part of EN 868 provides test methods and values for paper used in the manufacture of preformed 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. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. NOTE 4 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 filters, 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.
Số hiệu tiêu chuẩn
prEN 868-6
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - 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 868-6 (2007-08)
Packaging materials for terminally sterilized medical devices - Part 6: Paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-6
Ngày phát hành 2007-08-00
Mục phân loại 11.080.30. Bao gói thanh trùng
55.040. Vật liệu bao gói và phụ tùng
Trạng thái Có hiệu lực
Thay thế bằng
EN 868-6 (2009-05)
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Số hiệu tiêu chuẩn EN 868-6
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 868-6 (2009-05)
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Số hiệu tiêu chuẩn EN 868-6
Ngày phát hành 2009-05-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-6 (2009-01)
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-6
Ngày phát hành 2009-01-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-6 (2007-08)
Packaging materials for terminally sterilized medical devices - Part 6: Paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-6
Ngày phát hành 2007-08-00
Mục phân loại 11.080.30. Bao gói thanh trùng
55.040. Vật liệu bao gói và phụ tùng
Trạng thái Có hiệu lực
Từ khóa
Blasting * Ethylene oxide * Goods * Hygiene * Inspection * Marking * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Packages * Packaging material * Packaging tests * Paper * Pore sizes * Products * Safety * Safety requirements * Specification (approval) * Sterilization (birth control) * Sterilization by irradiation * Sterilization (hygiene) * Sterilized goods * Sterilizers * Testing * Transport packing * Validation * Water repellency
Số trang
16