Biocompatibility Test

What Biocompatibility Testing Evaluates:

Toxicological safety (local and systemic effects)
Irritation or sensitization potential
Cytotoxicity
Hemocompatibility (if in contact with blood)
Implantation effects
Genotoxicity, carcinogenicity, and reproductive toxicity (if applicable)

These tests are designed to reflect the type of tissue/device contact, duration of exposure, and intended use of the product.

Our Support at RAPS

RAPS provides end-to-end support for biocompatibility evaluations, helping you navigate regulatory expectations under MDR and ISO 10993-1. Our services include:

Material risk assessment and biological evaluation planning
Coordination of preclinical laboratory testing
Review and interpretation of test results
Support for technical documentation submission
Guidance for Notified Body interactions and regulatory responses

Whether you're developing an implantable device or a product with surface or mucosal contact, RAPS ensures your device meets biological safety standards—cost-effectively and efficiently.

Importance of Biocompatibility Testing

Biocompatibility testing plays a vital role in ensuring the safety and performance of medical devices that come into contact with the human body. The interaction between device materials and biological systems can result in a wide range of responses—from harmless to highly toxic. As such, thorough evaluation is essential for regulatory compliance and patient safety.

Why Biocompatibility Testing Matters

Medical devices may release extractable chemical compounds or retain residual processing agents that can negatively impact biological systems, such as the immune or nervous system. These interactions can lead to systemic toxicity, inflammation, or long-term adverse effects.

Even if individual materials used in a device are biocompatible, their combined formulation may result in unforeseen toxic reactions. Therefore, the entire device, not just its components, must be tested for biocompatibility.

Key Factors Influencing Biocompatibility

Chemical and physical properties of the materials
Type and duration of tissue exposure
Patient contact site (e.g., skin, blood, internal organs)
Nature of device use (temporary, long-term, implantable, etc.)

Testing involves analytical chemistry, in vitro assays, and in vivo models, forming an essential part of the device’s overall biological risk assessment.

Common Biocompatibility Tests Include:

Cytotoxicity Testing – Assesses cellular toxicity
Acute Systemic Toxicity Testing – Identifies short-term systemic effects
Subchronic and Chronic Toxicity Testing – Evaluates longer-term effects
Sensitization and Irritation Testing – Detects allergic or localized inflammatory reactions
Genotoxicity and Carcinogenicity Testing – Assesses genetic and cancer risks
Reproductive/Developmental Toxicity Testing – Evaluates effects on fertility and development
Hemocompatibility Testing – Assesses blood interactions
Implantation and Biodegradation Testing – Evaluates tissue responses and material breakdown over time
Intra-cutaneous Irritation Testing – Detects localized dermal reactions

RAPS: Your Partner in Biocompatibility Strategy

At RAPS, we assist manufacturers through the planning, execution, and documentation of biocompatibility testing programs in accordance with ISO 10993-1 and MDR requirements. From early-stage material review to final safety reporting, we streamline the process for faster market access and full regulatory compliance.

Medical Device In-Vitro & In-Vivo Biological Testing

Biological testing is essential to ensure that medical devices are safe, non-toxic, and compatible with the human body. Depending on the nature of the device and its intended use, both in-vitro and in-vivo testing methods may be required under ISO 10993 standards.

In-Vitro Testing

In-vitro testing is conducted outside of a living organism, typically in a controlled laboratory environment using cultured mammalian cells. This method is ideal for early-stage safety screening and involves assessing the cytotoxicity of medical device materials.

One of the most common in-vitro tests is:

Cytotoxicity Testing – Measures how materials or their extracts affect the viability and health of cultured cells. It helps identify potentially harmful substances that may leach from a medical device.

In-vitro results serve as an initial indicator of biocompatibility and determine whether further in-vivo testing is necessary.

In-Vivo Testing

In-vivo testing is conducted within a whole, living organism, such as an animal model, and is typically required following in-vitro studies—especially for devices with direct tissue or systemic exposure.

The extent and type of in-vivo testing depend on the device’s classification, risk level, and intended use. Common in-vivo biological tests include:

Skin Irritation Testing
Sensitization Testing
Implantation Testing
Systemic Toxicity Testing
Subchronic and Chronic Toxicity Testing

These tests assess local and systemic reactions, as well as long-term biological effects. Depending on the test type, turnaround times can vary from a few weeks to several months.

RAPS: End-to-End Biological Testing Support

At RAPS, we guide manufacturers through the full spectrum of biological safety testing—from test planning and lab coordination to documentation and regulatory submission. Our goal is to help you meet MDR, FDA, and ISO 10993 requirements with precision and efficiency.

Biocompatibility Testing for Medical Devices

Why Is Biocompatibility Important?

What Biocompatibility Testing Evaluates:

Our Support at RAPS

Importance of Biocompatibility Testing

Why Biocompatibility Testing Matters

Key Factors Influencing Biocompatibility

Common Biocompatibility Tests Include:

RAPS: Your Partner in Biocompatibility Strategy

Medical Device In-Vitro & In-Vivo Biological Testing

In-Vitro Testing

In-Vivo Testing

RAPS: End-to-End Biological Testing Support

Biocompatibility Testing for Medical Devices

Why Is Biocompatibility Important?

What Biocompatibility Testing Evaluates:

Our Support at RAPS

Importance of Biocompatibility Testing

Why Biocompatibility Testing Matters

Key Factors Influencing Biocompatibility

Common Biocompatibility Tests Include:

RAPS: Your Partner in Biocompatibility Strategy

Medical Device In-Vitro & In-Vivo Biological Testing

In-Vitro Testing

In-Vivo Testing

RAPS: End-to-End Biological Testing Support

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