STN EN 868-5
| Name: | STN EN 868-5 |
| Validity: | Valid |
| Number of pages: | 22 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Obaly na zdravotnícke pomôcky sterilizované v konečnom obale. Časť 5: Uzavierateľné vrecká a zvitky z pórovitých materiálov a plastových fólií. Požiadavky a skúšobné metódy |
| English title | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| Release Date: | 01. 06. 2019 |
| Date of withdrawal: | |
| ICS: | 11.080.30 |
| Sorting character/National clasification code | 85 6543 |
| Level of incorporation: | idt EN 868-5:2018 |
| Official Journal | 05/19 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN 868-5:2009-11 (85 6543) |
| Note in Official Journal: | |
| Subject of the standard: | This document 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. These sealable pouches and reels are 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 document. The materials specified in this part of EN 868 are intended for single use only. |
| Preview: | Náhľad normy (PDF) |