Muscle Implantation Biocompatibility Testing (ISO 10993-6)
1. Biological Effect: In Vivo Tests
2. Turnaround time: 12 or 21 weeks or more (after approval from Local Ethics Committee)
3. Sample Requirements:
ISO
to be individually determined;
4. Animal Quantity: 3 rabbits
5. Duration of implantation: 4 weeks or 13 weeks or to be individually determined
ISO 10993-6
The purpose of the study is to evaluate the medical device for local effects on living tissue when implanted in the muscles of the rabbit. The bioreactivity of a test item is determined through microscopic and macroscopic through a comparison of the tissue response caused by the medical device as compared to an appropriate control material. The area of the tissue surrounding the center position of each implant will be processed and a histopathologist will process the implanted sites for histopathological evaluation.
Muscle implantation testing sounds technical, but at its core, it’s about trust. Before a medical device ever reaches a patient, regulators want proof that the materials inside it are safe when placed in living tissue.
ISO 10993-6 sets the rules, and that’s the framework labs like NABI follow. Our role? To run controlled studies that show how muscle tissue reacts (whether it heals cleanly, gets inflamed, or develops scar tissue), so manufacturers can submit reliable data to the FDA or European regulators.
It’s a process that blends science with responsibility. On one side, you’ve got the hard facts: timelines, histology slides, ethics approvals. On the other, you’ve got the human impact: making sure devices don’t cause harm once they’re implanted in real people. That balance is exactly where NABI specializes.
What is the muscle implantation test?
The muscle implantation test is a biocompatibility study defined under ISO 10993-6. It evaluates how muscle tissue reacts when a medical device material is implanted, measuring inflammation, healing, and overall tissue compatibility.
Regulators like the FDA in the United States and notified bodies in Europe (under MDR) rely on these results before approving a new device. Without clear evidence that a material can sit safely inside living tissue, the product won’t move forward in the approval process.
Why muscle tissue? It’s a dynamic environment:
- constantly moving
- well supplied with blood
- capable of strong healing responses
That makes it a realistic and sensitive way to see how a material performs under stress. If a polymer, metal, or ceramic holds up here, it’s a good sign for long-term use in humans.
During the study, scientists look for specific outcomes:
- Necrosis (whether tissue dies around the implant)
- Fibrosis (scar tissue formation)
- Capsule formation (how the body walls off the implant)
- Inflammation (immune response, both acute and chronic)
Together, these markers paint a clear picture of compatibility.
At NABI, results are compared against control samples to make sure findings are accurate and meaningful.
How long do muscle implants last?
Muscle implants used in research studies last for the duration of the test protocol. Most often 4 weeks for sub-chronic studies or 13 weeks for chronic studies.
When discussing biocompatibility testing, timelines are tightly controlled. A 4-week study gives regulators insight into how tissue reacts in the short term, while a 13-week study provides evidence of long-term safety. These windows are carefully chosen to mirror how the body might respond during the early healing phase versus later, once the implant has been integrated.
How much do muscle implants tests cost?
For NABI’s muscle implantation studies, pricing is structured as follow:
- Sample preparation – sterilization, sizing, and labeling
- Ethics approval – required before testing begins
- Histology analysis – microscopic evaluation of tissue samples
- Study duration – short-term (4 weeks) vs. long-term (13 weeks or more)
Each of these elements changes the timeline and total cost, which is why there’s no flat rate.
Request a custom quote from NABI to get exact pricing based on your material and study needs.
Why choose NABI for muscle implantation testing?
When you’re preparing for regulatory submission, the quality of your data matters as much as the product itself. Here’s what sets NABI apart:
- Recognized certifications. All studies follow ISO 10993, with GLP compliance and ISO 17025 accreditation, ensuring results meet FDA and MDR expectations.
- Ethical responsibility. Animal welfare is part of the study design, reviewed and approved before any testing begins.
- Efficient timelines. Most projects are completed within 12–21 weeks, so you don’t lose momentum waiting for results.
- Flexible sample requirements. No one-size-fits-all. We adapt protocols to fit your specific material and submission needs.
- Clear deliverables. Clients receive comprehensive reports, histopathology images, and gross observations, giving regulators a full picture of tissue response.
In short, NABI combines compliance, ethics, speed, and clarity. We’re helping you move through the regulatory process with confidence.
FAQs about Muscle Implantation Biocompatibility Testing
What animals are used in muscle implantation tests?
Most muscle implantation studies use rabbits as the test model, since their muscle tissue is well suited for observing local responses. The choice of animal is always reviewed by an ethics committee to ensure compliance with animal welfare standards.
What regulatory agencies accept ISO 10993-6 results?
Results generated under ISO 10993-6 are accepted by major regulatory bodies, including the FDA in the United States and European authorities under the Medical Device Regulation (MDR). Many other international agencies also recognize these studies as part of device approval.
How are tissue reactions evaluated (gross vs microscopic)?
Evaluations are done at two levels:
- Gross observations – visual inspection of the implant site for swelling, redness, or scarring.
- Microscopic analysis (histology) – tissue samples are examined under a microscope to detect inflammation, necrosis, fibrosis, or capsule formation.
How many samples do I need to provide?
The number of required samples depends on the study duration and the specific device material. NABI typically advises clients during project setup, ensuring enough samples are available for implantation, controls, and repeat testing if needed.
Can NABI shorten the 21-week timeline?
In some cases, timelines can be shortened if ethics approvals and sample preparation are already complete. However, long-term studies (like 13-week implants) cannot be compressed, since regulators require full-duration data. NABI works with clients to streamline everything possible without compromising compliance.
Get a Custom Quote for Muscle Implantation Testing
Every material and every study is different, which is why NABI provides custom quotes instead of flat pricing. By tailoring the design, timeline, and reporting to your needs, we make sure you get data that regulators will accept without delay.
Our team is ready to guide you through the process. If you’re also considering other studies, such as bone implantation or subcutaneous implantation, we can provide a combined package to save time and streamline submission.
For direct inquiries, you can reach us at:
Email: contact@nabi.bio
Phone: +1 (407) 278-6815