STN EN ISO 13408-1
| Name: | STN EN ISO 13408-1 |
| Validity: | Valid |
| Number of pages: | 96 |
| Language: |
EN
|
| Paper: | 31,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
28,62€ b) Without ability to print, with ability to copy (printscreen) 31,80€ c) With ability to print and copy (printscreen) 41,34€ |
| Slovak title | Aseptické spracovanie výrobkov na zdravotnú starostlivosť. Časť 1: Všeobecné požiadavky (ISO 13408-1: 2023) |
| English title | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6537 |
| Level of incorporation: | idt EN ISO 13408-1:2024, idt ISO 13408-1:2023 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 13408-1:2015-11 (85 6537) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series. |
| Preview: | Náhľad normy (PDF) |