SS-EN-13824 › Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable. NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.
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Designation Name
SS-EN 13824:2005
Revision Level
2005 EDITION
Status
Superseded
Publication Date
May 4, 2005
Language(s)
English
Page Count
62
International Equivalent
EN 13824:2004(IDT)