UNE-EN 868-5:2019
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Hardcopy , PDF
English, Spanish, Castilian
09-10-2019
This European Standard specifies 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.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.
The materials specified in this part of EN 868 are intended for single use only.
Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868-2, "3, 4- "6 and "7. Please consider that a positive ballot on prEN 858-5 during enquiry includes the approval of the revised scope.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN 868-5:2019-03 | Equivalent |
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