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Publikováno v:
Biopolymers for Biomedical and Biotechnological Applications
Autor:
Helin Räägel, Sarah Campbell, Matthew R. Jorgensen, Thor S. Rollins, Audrey P. Turley, Jeralyn Franson, Trevor Fish
Publikováno v:
Biomed Instrum Technol
To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (AN
Autor:
Kelly P Coleman, Chenghu Liu, Jia Liu, Wim H. de Jong, Chunguang Fan, Audrey P. Turley, Thor S. Rollins, Joseph W. Carraway
The ISO 10993 standards on biocompatibility assessment of medical devices discourage the use of animal tests when reliable and validated in vitro methods are available. A round robin validation study of in vitro reconstructed human epidermis (RhE) as
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5710a9f8633b162c61eb8d846c59ba54
http://hdl.handle.net/10029/624385
http://hdl.handle.net/10029/624385