Tolerable intake values for leachables: Practical use of ISO 10993-17 standard

Brown, Ronald P.

doi:10.1016/b978-0-08-102643-4.00006-9

Cited by 3 publications

(4 citation statements)

References 40 publications

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“…The Vero lineage is widely used for testing biomaterial cytotoxicity and is regulated by IS0 10993-5:2009 [71][72][73]. None of the tested biomaterials were cytotoxic for Vero cells, as evidenced by indirect and direct tests using the MTT assay to evaluate mitochondrial metabolism and optical microscopy to observe cellular morphology and behavior (Figure 2A-F).…”

Section: Discussionmentioning

confidence: 99%

“…The cultured hiPSC-NPC were maintained at 37 • C with 5% CO 2 , and media changes were performed daily. The indirect or extract test was performed according to ISO 10993-5:2009 [73]. For the assay, elution solutions of each biomaterial were prepared one day in advance, for which sterile pieces with an area of 3 cm 2 for each 1 mL of medium were required.…”

Section: Culture Of Neural Progenitor Cells Derived From Human Induce...mentioning

confidence: 99%

“…The direct test was performed according to ISO 10993-5:2009 [73] to analyze the cell morphology of Vero cells, SCC, and NPCdn in direct contact with the biomaterials. Cells were incubated under experimental conditions until the contact test (Vero: DIV 1, SCC, and NPCdn: DIV 7).…”

Section: Direct Contact Testmentioning

confidence: 99%

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The Impact of Biomaterial Surface Properties on Engineering Neural Tissue for Spinal Cord Regeneration

da Silva,

Bobotis,

Correia

et al. 2023

IJMS

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Tissue engineering for spinal cord injury (SCI) remains a complex and challenging task. Biomaterial scaffolds have been suggested as a potential solution for supporting cell survival and differentiation at the injury site. However, different biomaterials display multiple properties that significantly impact neural tissue at a cellular level. Here, we evaluated the behavior of different cell lines seeded on chitosan (CHI), poly (ε-caprolactone) (PCL), and poly (L-lactic acid) (PLLA) scaffolds. We demonstrated that the surface properties of a material play a crucial role in cell morphology and differentiation. While the direct contact of a polymer with the cells did not cause cytotoxicity or inhibit the spread of neural progenitor cells derived from neurospheres (NPCdn), neonatal rat spinal cord cells (SCC) and NPCdn only attached and matured on PCL and PLLA surfaces. Scanning electron microscopy and computational analysis suggested that cells attached to the material’s surface emerged into distinct morphological populations. Flow cytometry revealed a higher differentiation of neural progenitor cells derived from human induced pluripotent stem cells (hiPSC-NPC) into glial cells on all biomaterials. Immunofluorescence assays demonstrated that PCL and PLLA guided neuronal differentiation and network development in SCC. Our data emphasize the importance of selecting appropriate biomaterials for tissue engineering in SCI treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Culture Of Neural Progenitor Cells Derived From Human Induce...mentioning

confidence: 99%

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The Impact of Biomaterial Surface Properties on Engineering Neural Tissue for Spinal Cord Regeneration

da Silva,

Bobotis,

Correia

et al. 2023

IJMS

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“…[20][21][22][23] In addition to biological testing, the ISO 10993 includes physico-chemical analysis of solutes and verifies compliance with limit values for leachables. [24][25][26] Devices with noninvasive skin contact must be assessed for cytotoxicity, sensitization, and irritation. 27 The tests include both a worstcase extraction for general risk assessment and a simulating-use extraction under realistic conditions for the intended use case (detailed in the ISO 10993 Part 12 and Part 18).…”

Section: Introductionmentioning

confidence: 99%

Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products

Fink¹,

Fernandes²,

Weissmann³

et al. 2020

J Diabetes Sci Technol

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Background: The increasing offering of patch-based medical devices is accompanied by growing numbers of reported adverse skin reactions. Procedures for testing leachables according to ISO 10993 may not be optimal for lipophilic substances that can be mobilized on skin by sweat and sebum. We propose an improved extraction method for targeted analysis of leachables using low volumes of a sweat-sebum emulsion. The approach is illustrated by the analysis of isobornylacrylate (IBOA), a compound found in some devices and suspected for allergenic potential. Method: Three patch-based products were tested: an implantable device for continuous glucose monitoring (CGM), an intermittently scanned CGM (isCGM) device, and a micro-insulin pump. Quantification of IBOA was performed by gas chromatography and allergenic potential of IBOA levels was assessed by the KeratinoSens cell assay. Different combinations were used for extraction solvent (isopropanol, 5% ethanol-water solution, and sweat-sebum emulsion), extraction volumes (complete immersion vs partial immersion in 2 mm of solvent), and extraction time (3, 5, and 14 days). Results: Isobornylacrylate was only found in the isCGM device. About 20 mg/L IBOA were eluted after 3 days in isopropanol but only about 1 mg/L in ethanol-water. Sweat-sebum emulsion dissolves IBOA better and gives a more stable solution than ethanol-water. Decomposition of IBOA solutions requires adjusted extraction timing or correction of results. In the sweat-sebum extract, IBOA levels were about 20 mg/L after 3 days and about 30 mg/L after 5 days, clearly above the threshold found in the KerationSens assay for keratinocyte activation (10 mg/L). Conclusion: Extraction by low volumes of sweat-sebum emulsion can be a superior alternative for the targeted simulating-use assessment of leachables in patch-based medical devices.

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Review and Analysis of Biological Tests on Nanomaterials to be Applied in Biological Areas

Cuéllar-Gaona

Ibarra-Alonso

Reyna-Martínez

et al. 2023

Engineering Materials

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Tolerable intake values for leachables: Practical use of ISO 10993-17 standard

Cited by 3 publications

References 40 publications

The Impact of Biomaterial Surface Properties on Engineering Neural Tissue for Spinal Cord Regeneration

The Impact of Biomaterial Surface Properties on Engineering Neural Tissue for Spinal Cord Regeneration

Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products

Review and Analysis of Biological Tests on Nanomaterials to be Applied in Biological Areas

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