BIOCOMPATIBILITY

TESTING

Ferdiansyah

Medical Faculty of Airlangga University

Dr. Soetomo General Hospital
Surabaya
 Steps of Development of Biomaterial

Marketing

Monitoring of Safety
Phase 4 Safety, Eficacy, Side
and Side Effect
Post

effect
Clinical Research

Phase 2 -3 : Animal Biocompatibility, Safety, Innovative

- Human Efficacy, Quality of data Product

Phase 1 Biocompatibility, Innovative

Animal Safety, Efficacy Product

Validation of
products
Preclinical Research

Biocompatibility Safety
Prototype of
Biomaterial

Development manufacture & Characterization; Optimal in

processing structure & manufacture
chemical & processing

Steps Evaluation Outcomes

BRINGING TECHNOLOGY PLATFORMS
TO THE CLINICAL SETTING
 Biocompatibility
▪ Refers to interaction between a medical device and the
tissue and physiological systems of the patients treated by
the device
▪ An evaluation of biocompatibility is one part of the overall
safety assessment of a device
▪ Biocompatibility of devices is investigated using analitycal
chemistry, in vitro test and animal models
▪ Biocompatibility of a device depends on several factors,
including:
a. The chemical and physical nature of its component materials
b. The types of patient tissue that will be exposed to the device
c. The duration of that exposure
 FDA / ISO-10993 Standard

1. Cytotoxicity (ISO 10993-5)

2. Sensitization (ISO 10993-10)
3. Irritation or intracutaneous
reactivity (ISO 10993-10) Acute
systemic toxicity (ISO
10993-11) Subacute/subchronic
toxicity (ISO 10993-11)
Genotoxicity (ISO 10993-3)
4. Implantation (ISO 10993-6)
5. Hemocompatibility (ISO
10993-4)
6. Chronic toxicity (ISO 10993-11)
7. Carcinogenicity (ISO 10993-3)
 Device Categories By Nature Of
Contact
Medical devices fall into one of four categories based on
the nature of patient contact:
1. Non-Contact Devices; Devices that do not directly or
indirectly contact the patient are not required to
undergo biocompatibility testing.
2. Surface Devices
a. Contacting Intact Skin (e.g., electrodes, external
prostheses, fixation tapes, compression
bandages)
b. Contacting Mucous Membranes (e.g., contact
lenses, urinary catheters, colonoscopes,
endotracheal tubes)
c. Contacting Breached or Compromised Surfaces
(e.g., wound dressings, occlusive patches,
healing devices)
 Device Categories By Nature Of
Contact
3. External Communicating Devices
a. Contacting Blood Path Indirectly (e.g., solution administration
sets, I.V. extension sets, blood transfusion sets)
b. Contacting Tissue, Bone or Dentin (e.g., laparoscopes,
arthroscopes, draining systems, dental cements, skin staples)
c. Contacting Circulating Blood (e.g., intravenous and delivery
catheters, temporary pacemaker electrodes, dialyzers, dialysis
tubing, hemadsorbants, immuno-adsorbants)
4 Implant Devices
b. Contacting Tissue and/or Bone (e.g., orthopedic pins and
plates, pacemakers, breast implants, replacement tendons,
ligation clips, drug supply devices)
c. Contacting Blood (e.g., pacemaker electrodes, heart valves,
vascular grafts, ventricular assist devices, internal drug
delivery devices, stents)
BIOCOMPATIBILITY
SAFETY TESTING
[Based on ISO
10993-1 AND FDA
G95-1 Guidelines]

1 “Tissue” includes tissue fluids

and subcutaneous spaces.
2 For all devices used in
extracorporial circuits.
3 Pyrogenicity / Materials
Mediated should be considered.
4 Supplemental tests for
consideration.
● – ISO Evaluation Tests for
Consideration
◊ – Additional tests that the FDA
Biocompatability
Flow Chart for the
Selection of Toxicity
Test
Stockholm, June 2011
Thank you

Stockholm, June 2011