Chemical characterization is a critical facet of the medical device pipeline. It is part of any quality-assured research and development (R&D) phase of a device’s life cycle and is used to detect and mitigate risks.
This blog post will focus on how chemical characterization testing is used to demonstrate equivalency.
什么是化学表征测试？
In the medical device and pharmaceutical industries, risk management is a complex and crucial process that is carried out to ensure the safety of patients, employees, and companies. The chemical characterization of materials is vital to assess how safe a product is, based on its materials of construction.
In order to test the performance of the device in question, different scenarios will be created. These scenarios will vary based on the expected use conditions designed to provide a worst-case estimate of chemical release. Such testing allows analysts to learn what chemicals could be transferred from the device to the patient under certain conditions of use.
One of the critical components of chemical characterization testing is extractables and leachables testing.
提取物和浸润物测试
According to the ISO 10993 guidelines, extractables and leachables testing can be used to assist in determining a device’s biological safety. These procedures involve testing for potentially toxic materials and allow analysts to calculate the quantity and the speed at which compounds are released from the device and are transferred to the patient.
Risks Involved
If chemical characterization testing is not carried out, this poses numerous risks to patients. These risks include:
- Exposure of the patient to unexpected or harmful chemicals
- Not identifying toxic and harmful materials used in device construction
- Not meeting the ISO 10993 guidelines
What Is Equivalency?
Equivalence, in the context of medical and pharmaceutical devices, is the process of being able to show that two devices are equivalent to each other in terms of safety and clinical execution. By this definition, equivalence is not just being ‘similar’ to something—it’s much more.
为了使医疗设备等效，在测试中需要遵循一系列准则，从测试装置使用到化学特性。
These guidelines pose the following requirements:
- Is the ‘new’ device being used for the same purpose?
- Is the design similar?
- Are the testing conditions the same?
- Are the materials that come into contact with patients the same?
- Is the device used for the same clinical condition?
The extractables and leachables tests, can be utilized to determine what materials extract from the device, and provide data that supports the equivalency reports.
Why Is Equivalence Necessary?
对等效性是确保患者安全以及与设备及其材料接触的人的安全性。还需要证明该设备以相同的方式运行的设备已被批准的设备的工作。
在Jo乐动体育登录rdi Labs，我们在ISO 10993监管框架中经验丰富，并且是生物安全评估的世界领导者。如果您需要更多信息，我们可以提供有关安全标准和合规性的建议，以及化学表征测试，生物相容性和医疗设备测试。
