Need help?

EN ISO 13408-1:2024 Standard

wave
Save  

  Keywords:

#guidance #place #processes #document #aseptic

  Directive

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

  Last Official Journal reference

Wednesday 9th of October 2024

  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 ISO 11737-1:2018/A1:2021

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

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN ISO 20916:2024

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

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO ...

EN ISO 11607-2:2020/A1:2023

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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 17511:2021

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

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, t...

EN ISO 14971:2019

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

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

EN ISO 13485:2016

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

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

  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