ISO 18362:2016 PDF

ISO 18362:2016 Referenced Document

ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the 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 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
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

2022 ISO 18362:2016/Amd 1:2022 Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
2016 ISO 18362:2016 Manufacture of cell-based health care products - Control of microbial risks during processing