Need help?

EN ISO 13408-3:2011 Standard

wave
Save  

  Keywords:

#lyophilization #process #objectives #address #physical

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

  Purpose

This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

  Publication

Friday 17th of November 2017

  Related Standards

EN 13612:2002/AC:2002

In vitro diagnostic medical devices Directive (98/79/EC)

Performance evaluation of in vitro diagnostic medical devices

EN ISO 11607-1:2020

In vitro diagnostic medical devices Directive (98/79/EC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN 62304:2006

In vitro diagnostic medical devices Directive (98/79/EC)

Medical device software - Software life-cycle processesIEC 62304:2006

EN 61010-2-101:2002

In vitro diagnostic medical devices Directive (98/79/EC)

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements fo...

EN ISO 23640:2015

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

EN ISO 18113-1:2011

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and genera...

  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