What is a Toxicological Risk?
Toxicological risk measures the probability of an adverse effect being caused by a given compound. This covers effects such as skin irritation from topical treatments to more serious risks such as a material being carcinogenetic or fatal if ingested.
的严重程度和类型toxicological risk depend somewhat on how the compound will be used. Compounds used in devices that will be used under the skin have stricter toxicological risk assessment as the toxicological risk is more significant for small concentrations of compounds for internal use.
毒理学风险评估应描述毒理学风险的各个方面，包括集中和时间的安全暴露限制。进行完整的毒理风险评估对于批准任何新的医疗设备至关重要，如果不接受专家护理，可能会耗时且昂贵。1
The 4 Steps in Toxicological Risk Assessment
There are four main steps in toxicological risk assessment.2The first is Hazard Identification. Hazard Identification in a toxicological risk assessment means identifying any compounds that may pose a risk, no matter how slight.
毒理学风险评估中危险识别过程的一部分也在确定危害的性质 - 是致癌，神经毒性还是易燃？危害的性质至关重要，因为根据设备的预期用途，需要筛选不同的风险。
Next in the toxicological risk assessment is the dose-response assessment. This is about understanding what compound level could cause a toxic response and what conditions may be necessary to achieve this.
The exposure assessment involves looking at the population that might be exposed to the chemical undergoing the toxicological risk assessment. Many medical devices only pose a local risk to the individual patient, but others could potentially come into contact with other people who may also be vulnerable.
毒理风险评估的最后阶段是风险表征。这个阶段是关于了解特定危害发生的可能性以及潜在危害的影响有多严重。风险表征是表达毒理学风险评估结果以及风险或估计风险大小的任何潜在不确定性的地方。
毒理风险评估的关键应用
Toxicological risk assessments are an essential part of developing any new medical treatment or device. Whether new or existing materials are being used, compounds must be evaluated to see whether existing safety data can be used instead of further testing.
To find a partner to guide you through the toxicological risk assessment process, contact Jordi Labs. Jordi Labs have extensive experience in生物安全指南and toxicological risk assessments and can help you navigate the testing process.
To find out how bringing in an expert partner like Jordi Labs can help you accelerate the creation of your essential toxicological risk assessments, get in touch to find out more about the range of testing services and expert advice that Jordi Labs can offer.
- FDA (2022) ISO 10993-1,https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and, accessed May 2022
- National Research Council (US) Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology. Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment. Washington (DC): National Academies Press (US); 2007. C, Overview of Risk Assessment. https://www.ncbi.nlm.nih.gov/books/NBK10201/
