Biomaterials :Basic criteria and

classification

Compiled by:
Dr. Sujan Krishna Samanta
NSEC,Kolkata

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 Definition of Biomaterials
“A nonviable material used in a medical device, intended to interact
with biological systems.”

Early Definition (Historical):

“Lack of interaction between material and tissue”

Implies inert, non-toxic, non-carcinogenic, non-allergenic, non-

inflammatory, non-degradable
Thus, material has zero influence…
Contemporary Definition:
“Ability of a material to perform with an appropriate host response, in
a specific application”

interdependent mechanisms of interaction between material and tissue

“Ability of material to perform” and not just reside in the body
“Appropriate host response” must be acceptable given the desired function
“Specific application” must be defined
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 Definitions of Biomaterials (modern)
bi·o·ma·te·ri·al (n)
Material used to construct artificial organs, rehabilitation devices, or
prostheses and replace natural body tissues
(The American Heritage® Medical Dictionary, 2007)

A synthetic material used to replace part of a living system or to function in

intimate contact with living tissue (Park, 1995)

A systemically and pharmacologically inert substance designed for implantation

within or incorporation with living substances
(The Clemson University Advisory Board for Biomaterials)
A nonviable material used in a medical device, intended to interact with biological
systems (Williams, 1987)

A biomaterial is any material, natural or man-made, that comprises whole or part of a

living structure or biomedical device which performs, augments, or replaces a
natural function (Wikipedia) 3
 BACKGROUND
• Historically, biomaterials consisted of materials common in the
laboratories of physicians, with little consideration of material
properties.
• Early biomaterials :
- Gold: Malleable, inert metal (does not oxidize); used in dentistry by
Chinese and Romans--dates 2000 years
- Iron, brass: High strength metals; rejoin fractured femur (1775)
- Glass: Hard ceramic; used to replace eye (purely cosmetic)
- Wood: Natural composite; high strength to weight; used for limb
prostheses and artificial teeth
- Bone: Natural composite; uses: needles, decorative piercing

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 HISTORY
• Important dates
- 600 BC: Sushruta Samhita, Nose reconstruction
- 1860's: Lister develops aseptic surgical technique, wires and nails
made of iron, gold, silver and platinum
- early 1900's: W.A. Lane, Bone plates used to fix fracture

- 1930's: Introduction of stainless steel, cobalt chromium alloys

- 1938 : P. Wiles, first total hip prosthesis
- 1940's: Polymers (Plastics) in medicine: PMMA bone repair; cellulose for
dialysis; nylon sutures
- 1944 : W. J. Kolff, Hemodialyser
- 1946: J.Judet & R.Judet, Biomechanically designed hip prostheses, from
plastic.
- 1952: A.B. Voorhees, First blood vessel, made of cloth
Vinyon N Copolymer,
(polyvinyl chloride and polyacrylonitrile)
Nylon, Orlon®, Dacron®, Teflon®, Ivalon®

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 HISTORY (Contd)
- 1953: Dacron (polymer fiber) vascular grafts
- 1958: J. Charnley, Cemented (PMMA) joint, total hip replacement
- 1958: S.Furman & G.Robinson, First direct stimulation of heart
- 1960: A. Starr, M.I. Edwards, first commercial heart valves
- 1990: W.J. Kolff et al., Artificial heart

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 Requirements of Biomaterials

 Inert or specifically interactive

 Biocompatible
 Mechanically and chemically stable
 Biodegradable/bioresorable
 Process able (for manufacturability)
 Non-thrombogenic (if blood-contacting)
 Sterilizable

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 General properties and Criteria

1. Mechanical properties (strength)

2. Toxicity and Biocompatibility
3. Tissue response
4. Interfacial response
5. Performance
6. Regulation and ethics

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1. Mechanical properties of Biological materials and biomaterials

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2. Toxicity and Biocompatibility
A biomaterial should not be toxic
It deals with the substances that migrate out of biomaterials.

• There is no general set of criteria, for a material to qualify as

being biocompatible
– The time scale over which the host is exposed to the material or device must
be considered

material contact time

syringe needle 1-2 s

tongue depressor 10 s

contact lens 12 hr - 30 days

bone screw / plate 3-12 months

total hip replacement 10-15 yrs

intraocular lens 30 + yrs

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