This part of ISO 13408 specifies the general requirements and provides guidance for procedures, programs and procedures for the development, validation and routine control of the manufacturing process for aseptically manufactured healthcare products. This part of ISO 13408 includes requirements and guidance relating to the overall subject of aseptic manufacturing. Specific requirements and guidance for various specific processes and procedures related to filtration, lyophilization, cleaning in place (CIP) technologies, sterilization in place (SIP) and isolator systems are provided in others Parts of ISO 13408 listed. NOTE This part of ISO 13408 does not replace national regulatory requirements such as: B. Good Manufacturing Practices (GMP) and/or pharmacopoeia requirements that particularly affect national or regional jurisdictions.
EN ISO 13408-1:2015 Referenced Document
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking*， 2024-04-20 Update
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices*， 2024-04-20 Update
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 1 Geometrical product specifications (GPS) — Standard reference temperature for the specification of geometrical and dimensional properties*， 2022-06-14 Update
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO 9001:2008 Quality management systems - Requirements
ISO 9004:2009 Managing for the sustained success of an organization - A quality management approach
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
EN ISO 13408-1:2015 history
2015EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
2013EN ISO 13408-1:2011/A1:2013 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)
2011EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements [Superseded: CEN EN 13824]