Skip to Main Content
+1 (508) 881-6771
0
Menu Button

Medical Devices

1066

Development of an In Vitro Method for Assessing the Potential Irritation of Medical Devices and OTC Products Used in the Oral Cavity

The aim of this study was to evaluate an in vitro method using the EpiOralTM model, a three-dimensional cultured human buccal epithelium, for assessing the oral irritation potential of various products. […]
1063

Exploring the potential of reconstructed human epithelial tissue models for safety assessment of intraoral medical devices

Medical devices are integral to a wide array of medical interventions and are increasingly utilized in both clinical and home settings. Within the oral cavity, intraoral medical devices are employed […]
1062

Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol

Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, […]
1015

In Vitro Irritation Assay and Regulatory Acceptance Two Years after ISO 10993-23:2021 Release

Medical device biological safety testing is transitioning away from the use of animals to more technologically advanced and reliable in vitro alternative methods. The irritation potential of medical devices has […]
999

Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone

Background Ensuring menstrual cup safety is paramount, yet a menstrual cup safety assessment scheme is lacking. This paper presents a quadripartite scheme, showing how it can be applied. Methods The […]
984

Correlation of In Vitro and In Vivo Skin Irritation Assays in Medical Devices: A Case Study

Biocompatibility testing is moving away from animal-based assays in favor of technologically advanced and reliable in silico and in vitro alternative approaches. While irritation has traditionally been assessed in a […]
936

Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

Assessment of skin irritation is an essential component of the safety evaluation of medical devices. OECD Test Guideline 439 describes the use of reconstructed human epidermis (RhE) as an in […]
910

Novel cytokine marker available for skin irritation testing of medical devices using reconstructed human epidermis models

In biological safety evaluation of medical devices, false-negative results have been observed during skin irritation testing using the reconstructed human epidermis (RhE) model when measuring cell viability as a single […]
889

Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm™

Assessment of dermal irritation is an essential component of the safety evaluation of medical devices. Reconstructed human epidermis (RhE) models have replaced rabbit skin irritation testing for neat chemicals and […]
796

Evaluation of an In Vitro Human Dermal Sensitization Test for Use with Medical Device Extracts

In accordance with ISO 10993-10, the guinea pig maximization test, Buehler test, or murine local lymph node assay are used to assess the dermal sensitization potential of medical devices. The goal […]