ArticleFrontiers in medical technology2023
Toxic or not toxic? The specifications of the standard ISO 10993-5 are not explicit enough to yield comparable results in the cytotoxicity assessment of an identical medical device.
Article in Frontiers in medical technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 1 of them a synthesis that pooled it.
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Who cites it
73 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Therapeutic potential and safety challenges of antimicrobial peptides and peptidomimetics against ESKAPEE pathogens: a systematic review with quantitative analysis.The Journal of antimicrobial chemotherapy · 2026Pooled it
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- Development and characterization of an injectable dental follicle stem cell-secretome/nano-hydroxyapatite chitosan-alginate hydrogel: A cytocompatible scaffold for periodontal regeneration.Journal of Taibah University Medical Sciences · 2026Article
- Hydrogels in the Management of Peripheral Venous Disease: Bridging Material Design and Clinical Evidence.Gels (Basel, Switzerland) · 2026Review
- A Methodological Approach to Assessing Biocompatibility: 3D Printing and Subcutaneous Implantation in Rats.ACS omega · 2026Article
- Article
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- Monodisperse PEG engineering for quantifiable surface conjugation on PLGA nanoparticles.Nanoscale advances · 2026Article
- Banana Passion Fruit-Mediated Green Synthesis of Copper(I) Iodide Nanoparticles for Concrete Biodeterioration Control: Antimicrobial Activity, Cytotoxicity, and Mechanical Compatibility.Nanomaterials (Basel, Switzerland) · 2026Article
- Antibacterial and Immunomodulatory Coatings for Orthopedic Metal Implants: Biological Rationale, Design Strategies, and Translational Challenges.Advanced healthcare materials · 2026Review
- Valorization of Cocoa Pod Husk Through Integrated Drying and Probe Ultrasound-Assisted Extraction: Effects on Phenolic Composition, and Antioxidant and Cellular Anti-Inflammatory Activities.Foods (Basel, Switzerland) · 2026Article
- Patient-Specific Dual-Function 3D-Printed Gels for Antimicrobial and Analgesic Management of Alveolar Osteitis.ACS materials Au · 2026Article
- Adenosine 5'-monophosphate prevents sepsis-associated muscle wasting by activating AMPK and suppressing IL-1β inflammatory cytokines.Journal of intensive care · 2026Article
- Novel Triazole-Linked Xanthine-Steroid Hybrids: Molecular Docking and In Vitro Evaluation Against α-Glucosidase and MCF-7 Cells.Chemistry & biodiversity · 2026Article
- Towards standardizing cytotoxicity testing of 3D-printed orthodontic aligners and retainers: a scoping review.Progress in orthodontics · 2026Article
- Leucettinib-21 decreases dosage effects of DYRK1A in human trisomy 21 induced pluripotent stem cell-derived neural cells.Disease models & mechanisms · 2026Article
- Electroconductive Soft Microcarriers for Suspension Culture of Skeletal Muscle Cells.Macromolecular bioscience · 2026Article
- Dental Glass Ionomer Cement for Root Perforation Management: Physicochemical Characteristics and In Vitro Cell Response.Dentistry journal · 2026Article
- Biocompatibility of Direct 3D-Printed Clear Aligner Resins: A Comparative In Vitro Cytotoxicity Analysis.Journal of clinical and experimental dentistry · 2026Review
- Resiquimod-loaded MOF525 enables synergistic photodynamic therapy and immunotherapy for colorectal cancer.Nano convergence · 2026Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Medical device manufacturers are obliged to prove the biocompatibility of their products when they come into contact with the human body. The requirements for the biological evaluation of medical devices are specified by the international standard series ISO 10993. Part five of this series describes the performance of Objective: To determine if the specifications of the standard ISO 10993-5 are explicit to ensure the comparability of test results and, if not, identify potential influencing factors. Methods: An interlaboratory comparison was conducted for the Results: To our surprise only 58 percent of the participating laboratories identified the cytotoxic potential of both materials as expected. Particularly for PVC a considerable variation of the results between the laboratories was observed [mean = 43 ± 30 (SD), min = 0, max = 100]. We showed that ten percent serum supplementation to the extraction medium, as well as longer incubation of the cells with the extract, greatly increased the test sensitivity for PVC. Conclusion: The results clearly show that the specifications set by the ISO 10993-5 are not explicit enough to obtain comparable results for an identical medical device. To set requirements that ensure reliable cytotoxicity assessments, further research will be necessary to identify the best test conditions for specific materials and/or devices and the standard needs to be revised accordingly.
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