Need help?

EN ISO 13408-1:2024 Standard

wave
Save  

  Keywords:

#guidance #place #processes #document #aseptic

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 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

  Related Standards

EN IEC 60118-0:2024

Medical devices Regulation ((EU) 2017/745)

Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

EN ISO 10993-12:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

EN ISO 17665:2024

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterili...

EN ISO 14630:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - General requirements (ISO 14630:2024)

EN ISO 14155:2020/A11:2024

Medical devices Regulation ((EU) 2017/745)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 14155:2020

Medical devices Regulation ((EU) 2017/745)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0