Evaluation of Retention Range of Extractables Under Linear Gradient Conditions for Reversed-Phase Chromatographic Considerations and Requirements in Extractables Analytical Methods for Chemical Characterization of Medical Devices-Reference-Cited by-同舟云学术

Evaluation of Retention Range of Extractables Under Linear Gradient Conditions for Reversed-Phase Chromatographic Considerations and Requirements in Extractables Analytical Methods for Chemical Characterization of Medical Devices

Published:2022-07-07 Issue:8 Volume:85 Page:755-771
ISSN:0009-5893
Container-title:Chromatographia
language:en
Short-container-title:Chromatographia

Author:

Li Jianwei^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry

Link

https://link.springer.com/content/pdf/10.1007/s10337-022-04185-5.pdf

Reference87 articles.

1. ISO10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

2. ISO10993-18:2020, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

3. Jenke D (2018) Identification, analysis and safety assessment of leachables and extractables. Trends Anal Chem 101:56–65. https://doi.org/10.1016/j.trac.2017.10.024

4. Kiradzhiyska DD, Mantcheva RD (2019) Overview of biocompatible materials and their use in medicine. Folia Med (Plovdiv) 61:34–40. https://doi.org/10.2478/folmed-2018-0038

5. Sastri VR (2014) Materials used in medical devices. https://doi.org/10.1016/B978-1-4557-3201-2.00003-3

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