ISO 13408-2:2018 PDF

ISO 13408-2:2018 Referenced Document

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*， 2023-12-21 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 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-5 Aseptic processing of health care products - Part 5: Sterilization in place
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

2018 ISO 13408-2:2018 Aseptic processing of health care products — Part 2: Sterilizing filtration
2003 ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration