If you’re developing a medical device, Biocompatibility Services for Medical Devices from biocomptesting.com offers specialized, reliable, and regulation-ready testing to ensure your product is safe for human use.

1. Biocompatibility
SERVICES FOR
MEDICAL DEVICES

2. Biocompatibility is the ability of a medical device or material
to perform its intended function without causing harmful
biological effects — while eliciting an appropriate host
response
It ensures that devices will not trigger toxicity, irritation,
allergy or other adverse reactions when in contact with the
human body
What is
Biocompatibility?

3. Regulatory Framework –
ISO 10993 & Risk-Based
Evaluation
ISO 10993 defines the principles for
biological evaluation of medical devices
according to their intended use, duration
and type of body contact
A risk-based approach is used to decide
which tests are needed, avoiding
unnecessary testing while ensuring
safety and compliance

4. Tests – “The Big Three”
Core Biocompatibility
Cytotoxicity (in vitro) — tests if device
materials or extracts are toxic to living cells.
Sensitization (Allergy potential) — evaluates if
repeated exposure might cause allergic
(immune) response.
Irritation / Intracutaneous Reactivity —
assesses potential for skin or tissue irritation
upon contact.

5. Test Endpoints (as required)
Extended/Other Important
Hemocompatibility — for devices contacting blood, to check
for blood-cell damage, clotting or complement activation.
Implantation / Local Tissue Effects — for implanted
devices, assessing tissue response around implant site.
Genotoxicity / Carcinogenicity / Long-Term Toxicity — for
long-term-contact devices to assess risk of DNA damage,
cancer or systemic toxicity.
Chemical Characterization & Toxicological Risk
Assessment — to identify leachables or degradation
products that may pose risk over time.

6. Testing Matters (Benefits &
Importance)
Why Biocompatibility
Protects patient safety by ensuring devices do not
cause harmful biological reactions.
Helps regulatory compliance and smooth market
entry in regions following ISO 10993 / regulatory
guidelines.
Supports risk-based device design and material
selection — early detection of hazards prevents
costly redesign or recalls later.

7. How a Specialized
Biocompatibility
Provider Helps
Offers a full suite of relevant tests (from cytotoxicity to long-term
toxicity or hemocompatibility) under standard protocols.
Helps define the right test plan based on your device’s use case
(contact type, duration, materials), avoiding unnecessary tests.
Provides comprehensive reports that can be used for regulatory
submissions — supporting global market access.

8. Contact Us
Now
info@biocomptesting.com
949 315 7200
www.biocomptesting.com