STN EN ISO 11607-2/Zmena A1
| Name: | STN EN ISO 11607-2/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 28 |
| 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 sterilizované zdravotnícke pomôcky. Časť 2: Požiadavky validácie na procesy tvarovania, spájania a skladania. Zmena A1: Uplatňovanie manažérstva rizika (ISO 11607-2: 2019/Amd 1: 2023) |
| English title | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
| Release Date: | 01. 01. 2024 |
| Date of withdrawal: | |
| ICS: | 11.080.30 |
| Sorting character/National clasification code | 85 6543 |
| Level of incorporation: | idt ISO 11607-2:2019/Amd 1:2023, idt EN ISO 11607-2:2020/A1:2023 |
| Official Journal | 12/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. |
| Preview: | Náhľad normy (PDF) |