TIS 2395.2-2008
Biological evaluation of medical devices.part 2: animal welfare requirements

Standard No.
TIS 2395.2-2008
Release Date
2008
Published By
TH-TISI
Latest
TIS 2395.2-2008

TIS 2395.2-2008 history

  • 2008 TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements

TIS 2395.2-2008 -All Parts

TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing TIS 2395.10-2008 Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity TIS 2395.12-2008 Biological evaluation of medical devices.part 12: sample preparation and reference materials TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices TIS 2395.14-2008 Biological evaluation of medical devices.part 14: identification and quantification of degradation products from ceramics TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys TIS 2395.16-2008 Biological evaluation of medical devices.part 16: toxicokinetic study design for degradation products and leachables TIS 2395.17-2008 Biological evaluation of medical devices.part 17: establishment of allowable limits for leachable substances TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation TIS 2395.7-2008 Biological evaluation of medical devices.part 7: ethylene oxide sterilization residuals TIS 2395.9-2008 Biological evaluation of medical devices.part 9: framework for identification and quantification of potential degradation products


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