SS-EN-ISO-13408-3 › Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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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.
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Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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SS-EN ISO 13408-3:2011
July 12, 2011
EN ISO 13408-3:2011(IDT); ISO 13408-3:2006(IDT)