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EN ISO 13408-3:2011 Standard

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  Keywords:

#lyophilization #process #objectives #address #physical

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th 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

  Reference

This standard supersedes the "EN 13824:2004"

Anyway is still possible use the "EN 13824:2004" until December 31st, 2011

  Related Standards

EN ISO 13408-5:2011

Active implantable medical devices Directive (90/385/EEC)

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

EN ISO 13408-1:2015

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 11138-2:2009

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

EN ISO 11138-3:2009

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

EN ISO 10993-18:2020

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

EN ISO 11607-1:2020

Active implantable medical devices Directive (90/385/EEC)

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

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