ID 20758 | 13.11.2023 / Preview attached
ISO 13408-1:2023 Aseptic processing of health care products - Part 1: General requirements
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.
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Fonte: ISO
ID 22487 | 30.08.2024
Prassi di riferimento, in consultazione pubblica fino al 28 settembre 2024, per definirne strategie,...
3a Comunicazione di norme armonizzate per la Nuova Direttiva PED 2014/68/UE entrata in vigore il 20 Aprile 2016.
Comunicazione 2018/C 049/01 del 9 Feb...
ID 19312| 26.03.2023 / In allegato
ISO/TR 14283:2018
Implants for surgery – Essential principles of safety and performance
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
