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EN ISO 13408-3:2011 Standard

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  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 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 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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 ISO 11607-2:2020

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

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

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-1:2001/AC:2006

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

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