ISO 10993-17 Leachables Safety Evaluation for Orthopedic Devices
The ISO 10993-17 standard is a critical component of the regulatory requirements for orthopedic devices, particularly those made from polymers and metals that may release leachable substances during use. This service evaluates whether these leachables pose any potential risks to patients. Leachables are chemicals or other materials that can migrate into tissues when in contact with body fluids like blood, synovial fluid, or sweat.
The process involves a series of meticulous steps designed to identify all potential leachable substances from the device and then assess their toxicity using appropriate biological tests. The aim is to ensure patient safety by eliminating any harmful effects that could arise from these materials interacting with the body.
In the first step, we perform extensive extraction procedures on the orthopedic devices to simulate real-world conditions where the material interacts with bodily fluids. This can include soaking the device in physiological saline or other relevant solutions for extended periods. The extracts obtained are then analyzed using advanced analytical techniques such as High Performance Liquid Chromatography (HPLC), Mass Spectrometry, and Gas Chromatography-Mass Spectrometry (GC-MS).
The identified leachables are further evaluated through in vitro biological testing, which assesses the toxicity of these compounds on human cells. These tests can include cytotoxicity assays, genotoxicity studies, or subchronic toxicity evaluations depending on the nature and quantity of the leachables detected.
Our service ensures compliance with ISO 10993-17 by providing comprehensive data that supports the safety profile of orthopedic devices. Compliance is crucial for regulatory approval, ensuring that only safe products reach the market. This process not only protects patients but also enhances the reputation and trustworthiness of medical device manufacturers.
Understanding the leachable profiles of orthopedic devices is essential for several reasons. Firstly, it helps in identifying potential risks early in the product development cycle. Secondly, it allows for targeted modifications to minimize any identified risks without compromising the functionality or effectiveness of the device. Lastly, it provides robust data that can be used during regulatory submissions, ensuring a smoother path towards market approval.
| Standard | Description |
|---|---|
| ISO 10993-17:2018 | Leachables and extractables from medical devices – Part 17: Safety evaluation for leachables |
| ASTM E546 | Standard practice for extracting substances from polymers into physiological saline solution |
Applied Standards
The ISO 10993-17 standard is the cornerstone of our leachables evaluation service. This international standard provides a framework for identifying, extracting, and assessing potential leachable substances from medical devices to ensure their safety. The ASTM E546 standard complements this by offering specific practices for extracting polymers into physiological saline solutions, which are critical in simulating real-world conditions.
| Aspect | Description |
|---|---|
| Extraction | We use a variety of extraction methods, including immersion in physiological saline and exposure to body fluids, to simulate actual usage conditions. |
| Analytical Techniques | Data is collected using advanced analytical techniques such as HPLC, GC-MS, and MS/MS for precise identification of leachables. |
| Biological Testing | In vitro tests assess the toxicity of identified leachables on human cells to ensure they do not pose a risk. |
Why Choose This Test
The ISO 10993-17 leachables safety evaluation is essential for orthopedic device manufacturers looking to ensure the highest standards of patient care and regulatory compliance. By choosing this test, you are taking a proactive stance in safeguarding your product's reputation and ensuring its acceptance by regulatory bodies worldwide.
Our service offers several key advantages that set it apart from others:
- Comprehensive Analysis: We provide an exhaustive evaluation of all potential leachable substances, leaving no stone unturned in our pursuit of safety.
- Regulatory Compliance: Our methods align perfectly with international standards, ensuring that your product meets the stringent requirements set by regulatory authorities.
- Patient Safety: By identifying and mitigating risks early on, we contribute to enhancing patient well-being through safer orthopedic devices.
- Expertise: Our team of experienced professionals ensures that every step in the evaluation process is conducted with precision and accuracy.
In addition to these benefits, choosing our service also means you are investing in a future where innovation meets safety. We stay at the forefront of medical device testing, ensuring that your products not only comply with current standards but are also prepared for future regulatory changes.
