GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables (English Version)
This part of GB/T 16886 gives the principles for designing and implementing toxicokinetic studies of medical devices. Appendix A describes issues that should be considered in toxicokinetic studies for biological evaluation of medical devices.
GB/T 16886.16-2013 Referenced Document
GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
YY/T 0316-2008 Medical devices.Application of risk management to medical devices
GB/T 16886.16-2013 history
2021GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
2013GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
2003GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables