EN
SR EN ISO 13408-1:2024
Tratament aseptic pentru produse de îngrijire a sănătăţii. Partea 1: Cerinţe generale
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.
Status :
In vigoare
Data aprobării : 31.10.2024
Număr de pagini : 94
ICS : 11.080.01 Sterilizare si dezinfectare în general
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 13408-1:2016