STN EN ISO 13408-6
| Name: | STN EN ISO 13408-6 |
| Validity: | Valid |
| Number of pages: | 44 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Aseptické spracovanie výrobkov na zdravotnú starostlivosť. Časť 6: Izolátorové systémy (ISO 13408-6: 2021) |
| English title | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) |
| Release Date: | 01. 09. 2021 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6537 |
| Level of incorporation: | idt EN ISO 13408-6:2021, idt ISO 13408-6:2021 |
| Official Journal | 08/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 13408-6:2011-10 (85 6537) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements. |
| Preview: | Náhľad normy (PDF) |