Biocompatibility endpoints required for assessment as a part of a risk-based evaluation of medical device safety are provided by ISO 10993-1 and various international regulatory body standards and guidance documents.
The biocompatibility evaluation of medical devices is governed by standards, guidance documents and other regulations from around the world. These include, but are not limited to, International Organization for Standardization (ISO) 10993; U.S.
SETAC NA 2023 -- Environmental risk assessments (ERAs) for chemical, crop protection products and pharmaceuticals are necessary to fulfil global registration requirements. The data needed to describe environmental fate and aquatic or terrestrial hazards can lead to large testing programs and potentially high vertebrate usage.
SETAC NA 2023 -- The mealworm, Tenebrio molitor, is a holometabolous insect that lives in flour, bran and similar products. Owing to their use in large-scale conversion of plant biomass to protein, they are gaining status as an economically beneficial insect.
SETAC NA 2023 -- UVCB substances (Unknown, Variable composition, Complex reaction products, Biological) have many different constituents, some of which may be unknown. The composition can be variable or difficult to predict. Multi-constituent substances consists of several main constituents.
SETAC NA 2023 -- In this study, we explore the procedures and parameters required to optimise a GLP laboratory microcolony feeding test to determine whether sugar syrup and pollen contaminated with doses of a test item could affect the food consumption, worker survival and size of the brood, as well as cause any delay of adult emergence in the bumblebee Bo
ACT 2023 -- CByB6F1-Tg(HRAS)2Jic (Tg.rasH2) mouse model is the currently accepted transgenic mouse model for evaluation of carcinogenic potential of prospective new therapeutics. The model is run in place of a 2-year mouse carcinogenicity assay and can be completed in 26-weeks.
SETAC NA 2023 -- Current approaches for the safety assessment of human health and environmental risks due to chemical exposure have heavily relied on using animal models. The approach has generally been conservative and as such there has been a reluctance to change the way we perform risk assessments.
