IN 556-1: 2006 – Sterilization of medical devices
EN 1041: 2008 – Specialized data about medical devices
EN ISO 10993-1:2009+A1:2010 – Assessment and testing in the risk management process
EN ISO 10993-5: 2009 – Biological assessment of medical devices: Cytotoxicity tests
EN ISO 10993-10: 2010 – Biological assessment of medical devices: Studies on skin irritation and sensitization
EN ISO 11137-1:2006 – Sterilization of products used in healthcare – Ionizing radiation
Requirements for the development, validation and routine control of the sterilization process of medical devices
EN-ISO 11137-1:2006/AC:2009 – Sterilization of products used in healthcare – Ionizing radiation
– Part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices
EN ISO 11137-2:2009 – Sterilization of products used in healthcare – Ionizing radiation
– Part 2: Determination of the sterilization dose
EN ISO 13485: 2016 – Medical devices – Quality management systems
ISO 14820-2004 – Fertilizers and liming materials – Collection
and sample preparation
EN ISO 14971: 2012 – Medical devices – Application of risk management to medical devices
EN ISO 15223-1: 2016 – Medical devices – Symbols for use on medical device labels, their labeling, and the information provided with them
