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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
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immediate downloadReleased: 2015-08-31
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements

BS EN ISO 13408-1:2015

Aseptic processing of health care products General requirements

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Standard number:BS EN ISO 13408-1:2015
Pages:62
Released:2015-08-31
ISBN:978 0 580 90760 9
Status:Standard
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BS EN ISO 13408-1:2015


This standard BS EN ISO 13408-1:2015 Aseptic processing of health care products is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general
ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
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