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prEN 868-8

Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Số trang: 19
Ngày phát hành: 2007-08-00

Liên hệ
This Part of EN 868 provides test methods and values for re-usable containers for steam sterilization. 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. The containers specified in this part of the standard are intended to be used as a packaging system during the sterilization of medical devices in steam sterilizers conforming to EN 285 and the subsequent transportation and storage of those devices. NOTE 1 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e. g. operating temperature. NOTE 2 When goods are required to be multiply wrapped in order to fulfil the general requirements, they should first be packaged in a sterilization packaging material (e. g. a material as specified in other parts of this series of standards).
Số hiệu tiêu chuẩn
prEN 868-8
Tên tiêu chuẩn
Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Ngày phát hành
2007-08-00
Trạng thái
Hết hiệu lực
Tiêu chuẩn tương đương
DIN EN 868-8 (2007-10), IDT * 07/30167330 DC (2007-08-15), IDT * S98-051-8PR, IDT * OENORM EN 868-8 (2007-10-01), IDT
Tiêu chuẩn liên quan
Thay thế cho
Thay thế bằng
prEN 868-8 (2009-01)
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-8
Ngày phát hành 2009-01-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
Lịch sử ban hành
EN 868-8 (2009-05)
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Số hiệu tiêu chuẩn EN 868-8
Ngày phát hành 2009-05-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-8 (2009-01)
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-8
Ngày phát hành 2009-01-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
* prEN 868-8 (2007-08)
Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Số hiệu tiêu chuẩn prEN 868-8
Ngày phát hành 2007-08-00
Mục phân loại 11.080.30. Bao gói thanh trùng
Trạng thái Có hiệu lực
Từ khóa
Applications * Containers * Hygiene * Inspection * Marking * Materials * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Packages * Packaging material * Packaging tests * Products * Re-usable * Safety * Safety requirements * Specification (approval) * Steam sterilization * Sterilization (birth control) * Sterilization (hygiene) * Sterilized goods * Sterilizers * Storage * Testing * Transport packing * Validation * Tanks * Bearings * Implementation * Use
Số trang
19