Biocompatibility Test Matrix

Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards
and Food and Drug Administration (FDA) guidance (May 1, 1995). The table is based on ISO 10993-1 Evaluation and

Medical Research Organization

MRO
Testing, 2009 edition. While the table has been developed as a guideline for biocompatibility testing, it is essential
that each device be evaluated based on its own unique characteristics.

Device Categories Biological Effect

Subchronic Toxicity (Subacute toxicity)

Contact Duration
A = Limited (≤24 Hours)

Irritation/Intracutaneous

Acute Systemic Toxicity

B=P  rolonged (24 Hours –
Body Contact
30 Days)

Hemocompatibility
C = Permanent (>30 Days)

Chronic Toxicity

Carcinogenicity
Sensitization

Genotoxicity

Implantation
Cytotoxicity

Biocompatibility Test Matrix

A x x x
Skin B x x x
C x x x
A x x x
Mucosal
Surface Devices B x x x o o o
Membrane
C x x x o x x o o
A x x x o
Breached or
Compromised B x x x o o o
Surfaces
C x x x o x x o o
A x x x x x
Blood Path,
B x x x x o x
Indirect
C x x o x x x o x o o
A x x x o
Externally
Tissue/Bone/
Communicating B x x x x x x x
Dentin1
Devices
C x x x x x x x
A x x x x o 2
x
Circulating
B x x x x x x x x
Blood
C x x x x x x x x o o
A x x x o
Tissue/Bone B x x x x x x x
C x x x x x x x o o
Implant Devices
A x x x x x x x
Blood B x x x x x x x x
C x x x x x x x x o o
Clinical
Testing
Consulting

X = Tests per ISO 10993-1 Note1 – T

 issue includes tissue fluid and To access a copy of this online, visit:
O=A
 dditional tests that may be subcutaneous spaces www.namsa.com/bio or search
applicable in the U.S. Note2 – F
 or all devices used in “biocompatibility-matrix”
extracorporeal circuits

North American Science Associates, Inc. © 2016. | doc-id: [ T2.037.00 ]. www.namsa.com

Biocompatibility Test Matrix

Notes:

Medical Device
Development 1 2 3 4 5
Process & The
MRO® Approach
CONCEPT & DESIGN VALIDATION & MARKET
CLINICAL POST-MARKET
FEASIBILITY PRECLINICAL TESTING APPROVAL

NAMSA World Headquarters North American Science Associates, Inc.

6750 Wales Rd © 2016. | doc-id: [ T2.037.00 ].
MRO Northwood, OH USA
+1-866-666-9455(toll free) For more information visit:
Medical Research Organization +1-419-666-9455(Outside of USA) www.namsa.com