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U.S. Department of Health and Human Services

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Standards and Guidance Documents Impacted by the Laboratory of Toxicology and Biocompatibility

  • ISO/PDTS 29741 Biological evaluation of medical devices — Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP). 
  • Guidance Document:  Medical Devices Incorporating Nanotechnology – Draft (2010).

  • ISO10993 – Biological Evaluation of Medical Devices.