BS EN ISO 13408-2:2018
Aseptic processing of health care products. Sterilizing filtration

Standard No.

BS EN ISO 13408-2:2018

Release Date

2018

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 13408-2:2018

Replace

BS EN ISO 13408-2:2011

BS EN ISO 13408-2:2018 Referenced Document

• ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*， 2023-12-23 Update
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
• ISO 11139 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
• ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
• ISO 13408-3 Aseptic processing of health care products - Part 3: Lyophilization
• ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies
• ISO 13408-5 Aseptic processing of health care products - Part 5: Sterilization in place
• ISO 13408-6 Aseptic processing of health care products — Part 6: Isolator systems*， 2021-04-13 Update
• ISO 13408-7 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
• ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO/IEC 90003 Software engineering - Guidelines for the application of ISO 9001:2008 to computer software

BS EN ISO 13408-2:2018 history

• 2018 BS EN ISO 13408-2:2018 Aseptic processing of health care products. Sterilizing filtration
• 2011 BS EN ISO 13408-1:2011+A1:2013 Aseptic processing of health care products. General requirements
• 0000 BS EN ISO 13408-1:2011
• 2004 BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements