STN EN 868-8
| Name: | STN EN 868-8 |
| 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 8: Kontajnery na opakované použitie pre parné sterilizátory podľa EN 285. Požiadavky a skúšobné metódy |
| English title | Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - 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 868-8:2018 |
| Official Journal | 05/19 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN 868-8:2009-11 (85 6543) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users. 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. NOTE 2 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. |
| Preview: | Náhľad normy (PDF) |