Biocompatibility is defined as “ability of a medical device or material to perform with an appropriate host response in a specific application”.
The following information shall be
considered for evaluating the overall biological evaluation of the medical
device:
- a) Direct and indirect tissue contacting materials
- b) Additives, process contaminants and residues
- c) Packaging materials
- d) Leachable substances
- e) Degradation products
- f) Performance and physical characteristics of the final product
This helps for selection of appropriate tests relevant for medical devices.
Categorization by
nature of body contact |
Categorization by
duration of contact |
Non-contacting
medical devices Surface-contacting medical devices Skin,Mucosal
membrane ,Breached or compromised surfaces Externally communicating medical devices Blood path, indirect,
Tissue/bone/dentin, Circulating blood Implant medical devices Tissue/bone,
Blood |
Limited exposure (A)
– duration of contact is up to 24 h. Prolonged exposure
(B) – contact time is likely to exceed 24 h but not
exceed 30 days. Long-term exposure
(C) –contact time exceeds 30 days |
- Transitory-contacting medical devices have limited exposure (A) and these devices does not require testing to address biocompatibility. But for products made with materials such as coatings or lubricants needs testing.
- Medical devices with multiple contact duration categories require more rigorous testing and/or evaluation considerations shall apply.
Step 2: Conduct a physical and/or
chemical characterization per ISO 10993-18.
the intended application and physical
properties have not changed, then no further testing required and rationale
shall be documented.
S.No |
Testing |
Type of Devices to
be tested |
Categorization by
nature of body contact |
Categorization by
duration of contact |
1 |
Physical and/or
chemical information |
All medical device
categories |
all types of contact |
all durations of
contact |
2 |
Irritation or
intracutaneous reactivity |
externally
communicating medical devices |
indirect blood path
contact |
long term duration |
3 |
Material mediated
pyrogenicity and acute systemic toxicity |
medical devices with
breached or compromised
surface contact |
all
durations of contact |
|
4 |
Material
mediated pyrogenicity |
externally
communicating medical devices and implant medical
devices |
all types of contact |
all durations of
contact |
5 |
Acute
systemic toxicity |
surface
medical devices |
mucosal membrane
contact |
prolonged or long-term
contact |
externally
communicating medical devices |
tissue/ bone/dentin contact |
limited duration |
||
implant
medical devices |
tissue/bone contact |
limited duration |
||
6 |
Subacute
toxicity |
all medical device
types |
prolonged and long
term contact |
|
7 |
Subchronic
and chronic toxicity |
all
medical device types |
long
term contact |
|
8 |
Implantation effects |
surface medical
devices |
mucosal membrane
contact |
prolonged or long
term contact |
surface medical
devices |
breached or
compromised surface contact |
prolonged or long
term contact |
||
externally
communicating medical devices |
indirect
blood path contact |
long
term duration |
||
9 |
Genotoxicity |
externally
communicating medical devices |
circulating
blood contact |
limited
duration |
10 |
implant
medical devices |
blood contact |
limited
duration |
|
11 |
Carcinogenicity |
surface medical
devices |
breached or
compromised surface contact |
long
term duration |
12 |
externally
communicating medical devices |
all types of contact |
long
term duration |
|
13 |
implant
medical devices |
all types of contact |
long
term duration |
For US FDA regulatory submission please
use the US FDA guidance document “Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process"
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