Material Requirements for Plastics used in Medical Devices

Sastri, Vinny R.

doi:10.1016/b978-0-8155-2027-6.10004-2

Cited by 34 publications

(47 citation statements)

References 5 publications

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“…The cytotoxicity test using agar diffusion is a qualitative assay that can be used for materials with different physical constitutions, including oily materials such as cosmetics, due to its feasibility and convenience [49]. However, although the neutral red assay is a quantitative test, which enables the calculation of the cytotoxicity index, the extraction of potential toxic elements or compounds is performed in an aqueous medium, which makes the analysis of certain materials difficult [48]. On the other hand, as stated by Sehnem [41], both qualitative and quantitative methods are equivalent and the choice of the most appropriate method must be made according to the type of analysis being conducted, i.e., qualitative when using the agar diffusion method or quantitative when performing the neutral red incorporation assay [41].…”

Section: Validation and Test Resultsmentioning

confidence: 99%

“…Since the 22 nd USP review, the agar diffusion test has been introduced as an in vitro biological reactivity assay to assess the safety of plastics for medical use [15,47,48].…”

Section: In Vitro Cytotoxicity Assay By the Agar Diffusion Methods (Inmentioning

confidence: 99%

“…This substance is soluble in dimethyl sulfoxide (DMSO) and other organic solvents, but insoluble in water. The amount of crystals formed is positively correlated to the number of cells and their activity, and the measurement of the colorimetric value of the absorbance (optical density) reflects the number of surviving cells and metabolic activity [48].…”

Section: Mtt Assaymentioning

confidence: 99%

“…Only lysosomes in viable cells retain neutral red; therefore, it is possible to distinguish stained viable cells from decolored, damaged or dead cells. After diluting neutral red dye in an ethanol/acetic acid solution, lysosomal activity is measured at 540 nm in a spectrophotometer [48][49][50][51].…”

Section: Neutral Red Assaymentioning

confidence: 99%

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Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

Vidal¹,

Granjeiro²

2017

JBiSE

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The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.

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Section: Validation and Test Resultsmentioning

confidence: 99%

“…Since the 22 nd USP review, the agar diffusion test has been introduced as an in vitro biological reactivity assay to assess the safety of plastics for medical use [15,47,48].…”

Section: In Vitro Cytotoxicity Assay By the Agar Diffusion Methods (Inmentioning

confidence: 99%

Section: Mtt Assaymentioning

confidence: 99%

Section: Neutral Red Assaymentioning

confidence: 99%

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Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

Vidal¹,

Granjeiro²

2017

JBiSE

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“…Polymer materials play important roles in various scientific fields such as electronics, 1 biomaterials, 2 medical devices, 3 and aerospace engineering. 4 The chemical and physical properties of polymer materials are often governed not only by their chemical structures but also by hierarchical structures, a representative example of which is the phase-separated structure of a binary polymer blend.…”

Section: Introductionmentioning

confidence: 99%

Nanometer-scale Real-space Observation and Material Processing for Polymer Materials under Atmospheric Pressure: Application of Atmospheric Scanning Electron Microscopy

et al. 2014

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Direct observation of phenomena occurring under atmospheric conditions, especially at the nanometer scale, would offer a unique opportunity to understand the dynamics of various processes. A novel electron microscope, the atmospheric scanning electron microscope (ASEM), has recently been developed and allows for the observation of nanoscale objects under atmospheric conditions. In this paper, we present some examples of dynamic phenomena in polymer materials observed using ASEM. The first example is phase separation of a binary polymer blend upon solvent evaporation, a representative example of a non-linear non-equilibrium phenomenon in physics. Phaseseparated structures were found to appear at the final stage of solvent evaporation. Also, we found that irradiation of organic liquids (e.g., dibenzyl ether) with the ASEM electron beam induced polymerization, and the resulting material showed interesting cathodoluminescence behavior. Thus, ASEM may be useful as a tool for simultaneous polymerization and fabrication, in addition to offering a means for direct nanoscale observation of materials under atmospheric conditions.

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Shelf‐Stable Quantum‐Dot Light‐Emitting Diodes with High Operational Performance

et al. 2020

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Material Requirements for Plastics used in Medical Devices

Cited by 34 publications

References 5 publications

Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

Nanometer-scale Real-space Observation and Material Processing for Polymer Materials under Atmospheric Pressure: Application of Atmospheric Scanning Electron Microscopy

Shelf‐Stable Quantum‐Dot Light‐Emitting Diodes with High Operational Performance

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