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EN ISO 13408-3:2011 Standard

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  Keywords:

#lyophilization #process #objectives #address #physical

  Directive

Medical devices Directive (93/42/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 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 13408-1:2015

Medical devices Directive (93/42/EEC)

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

EN ISO 10993-14:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 1...

EN ISO 10993-17:2009

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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 11135-1:2007

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...

EN ISO 11137-1:2015

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

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