BS EN 868-5:2009 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 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.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.
BS EN 868-5:2009 only introduces performance requirements and test methods that are specific to the products covered by BS EN 868-5:2009 but does not add or modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
The materials specified in BS EN 868-5:2009 are intended for single use only.
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.
Cross References:EN 868-2
EN 868-3
EN 868-6
EN 868-7
EN 868-9
EN 868-10
EN ISO 11140-1
ISO 11140-1:2005
EN ISO 11607-1:2006
ISO 11607-1:2006
ISO 8601
EN 285
EN 1041
EN 13060
EN 1422
EN 14180
EN ISO 11607-2
ISO 11607-2:2006
EN ISO 14937
ISO 14937:2000
93/42/EEC
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 270 KB |
| ISBN(s) : | 9780580550058 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 22 |
| Product Code(s) : | 30166934, 30166934 |
| Published : | 10/31/2009 |
