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EN ISO 13408-1:2024 Standard

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  Keywords:

#guidance #place #processes #document #aseptic

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Monday 15th of June 2026

  Description:

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

  Purpose

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.

  Publication

Wednesday 9th of October 2024

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