Biocompatibility Certificate

What is Biocompatibility?

Biocompatibility refers to the ability of a material to coexist with living tissue or a biological system without causing harm. A biocompatible material is non-toxic, non-irritating, and does not cause physiological reactions when in contact with the body or bodily fluids. In the UK medical device industry, biocompatibility is a critical factor in ensuring product safety and regulatory compliance.

ISO 10993 Biocompatibility Testing

To standardise the biological evaluation of medical devices, the International Organization for Standardization (ISO) developed ISO 10993 – a set of guidelines outlining the categories, tests and procedures for determining the biocompatibility of materials.

ISO 10993 classifies medical devices by:

• Type of body contact (surface device, implant)

• Duration of contact (limited, prolonged, permanent)

Common ISO 10993 tests for medical products include:

• Haemolysis (ISO 10993-4)

• Cytotoxicity (ISO 10993-5)

• 14-day implantation (ISO 10993-6)

• Intracutaneous irritation and sensitisation (ISO 10993-10)

• Systemic toxicity (ISO 10993-11)

These tests help manufacturers ensure that materials used in devices do not pose biological risks.

What Is a Biocompatibility Certificate?

A biocompatibility certificate confirms that all materials and components used in a medical device are safe for human contact. It validates that a product meets strict biological safety requirements and complies with UK and international regulatory standards for medical devices.

The assessment process evaluates potential health risks associated with contact between the device and the human body, protecting patients from toxic, immunological, physiological, or mutagenic effects. It forms an essential part of a comprehensive medical device safety evaluation.

Why Are Biocompatibility Tests Conducted?

Biocompatibility tests are conducted to verify that a medical device or material does not:

• Cause skin irritation or allergic reactions

• Induce systemic toxicity

• Trigger local tissue responses or inflammation

These tests are necessary for both sterile and non-sterile medical devices that have direct or indirect contact with human tissues. The test scope depends on the device’s function, contact type (e.g., damaged skin, mucous membranes), and duration. More stringent tests are required for devices in contact with blood or used long-term within the body.

Key assessments include:

• Cytotoxicity – Determines if the material damages cells

• Sensitisation and irritation – Identifies potential allergic responses

• Chemical characterisation – Assesses the migration of substances from the device into surrounding tissue

• Haemocompatibility – Evaluates blood-device interactions

• Pyrogenicity – Checks whether the material causes fever or inflammation

• Genotoxicity – Detects toxins that may affect genetic material

• Biological burden – Measures microbial contamination

How Is Biocompatibility Testing Performed?

Tests are carried out using in vitro methods (test tubes or petri dishes) with animal cells or tissues exposed to the material to observe any cytotoxic effects over time. In some cases, in vivo tests are conducted on live animals to analyse the body's reaction to the material under real conditions.

Rubber Seals and O-Rings with Biocompatibility Certification

Explore our range of biocompatible seals and o-rings
from Power Rubber

Biocompatible rubber seals and o-rings are essential in many medical applications. They ensure tight, long-lasting seals in equipment such as respiratory devices, drug delivery systems, infusion pumps, and fluid transport systems.

To prevent leaks, failures or contamination, it’s crucial to choose the right size, shape, and material. Especially in medical applications, o-rings and seals must be highly efficient and tested for immune system response.

At Power Rubber, we provide o-rings and sealing components that meet ISO 10993 biocompatibility standards.

For any questions or to request documentation, contact us at:
+48 22 292 40 24 or +48 505 16 03 03
Email: Power@PowerRubber.com
Or use our contact form.