ISO 10993 17 Biological Evaluation of Polymers with Nano Additives
The ISO 10993-17 standard is pivotal for assessing the biological compatibility and safety of polymers that incorporate nanomaterials. This stringent protocol is designed to ensure that materials used in medical devices, pharmaceutical packaging, and other critical applications do not pose a risk to human health.
Testing under ISO 10993-17 involves a series of biocompatibility tests aimed at evaluating the potential adverse effects of nanomaterials on living tissues. These tests include in vitro cytotoxicity assays, genotoxicity evaluations, and subchronic toxicity studies among others.
The complexity arises from the unique properties of nanoparticles, which can behave differently compared to their macro counterparts. The challenge lies in understanding how these differences impact biological interactions at a cellular level. Our laboratory employs advanced analytical techniques such as particle size analysis, zeta potential measurement, and surface chemistry characterization to ensure precise control over nanoparticle behavior.
For accurate testing, specimens are prepared carefully according to the standard's requirements. This includes ensuring that any nanomaterials used are stable within the polymer matrix before being subjected to biocompatibility assessments. Our team ensures thorough quality assurance throughout every step of specimen preparation and testing.
The results from these tests provide critical information about the safety profile of polymers containing nano additives, helping manufacturers make informed decisions regarding product development and regulatory compliance.
Industry Applications
| Application | Description |
|---|---|
| Medical Devices | Ensuring the safety of implants and other devices used in surgical procedures. |
| Pharmaceutical Packaging | Evaluating the compatibility of packaging materials with drug formulations. |
| Consumer Goods | Assessing the safety of consumer products containing nanomaterials. |
| Aerospace & Defense | Testing the biocompatibility of materials used in protective gear and equipment. |
Why Choose This Test
Selecting ISO 10993-17 ensures that you are adhering to the most stringent international standards for evaluating nanomaterials in polymers. By choosing our laboratory, you benefit from experienced professionals who understand both the technical nuances and regulatory requirements associated with this field.
We offer comprehensive testing services tailored specifically towards identifying potential risks posed by nanomaterials within polymer structures. Our state-of-the-art facilities provide precise measurements and detailed data analysis, allowing us to deliver reliable results every time.
Our commitment to quality extends beyond just performing tests; it includes providing expert advice on best practices for incorporating nanotechnology into your products while maintaining compliance with relevant regulations.
International Acceptance and Recognition
- The United States Food and Drug Administration (FDA) recognizes ISO standards as acceptable alternatives to U.S. standards.
- European Union member states accept ISO standards without any additional requirements or modifications.
- ISO 10993-17 is widely adopted across Asia Pacific countries, including China and Japan.
