ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories*， 2017-11-29 Update
BS PD ISO/TR 15499:2016 history
2017BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process