Biocompatibility
Studies
Cytotoxicity
- ISO 10993-5
A cytotoxicity test determines whether a product
or compound will have any toxic effect due to
leachables on living cells. Generally used as
a screening tool for raw materials or component
products before they are put into the design of
a medical device.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| CY-NGLP |
Cytotoxicity Test
ISO
MEM Elution, Non-GLP Compliant |
Sample needed:
120 cm2 if sample is < 0.5
mm thick,
60 cm2 if sample is > 0.5
mm thick, 4 grams |
3-4 weeks |
| CY-GLP |
Cytotoxicity Test
ISO
MEM Elution, GLP Compliant |
3-4 weeks |
Sensitization
- ISO 10993-10
Tests for sensitivity to any part of a device
during exposure to the body for any length of
time. Exposure can create allergic or other sensitive
reactions.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| ST-GLP-30 |
Kligman Maximization (30
tests) Polar and Non-Polar Extracts Included,
GLP Compliant |
960
cm2 if sample is < 0.5 mm thick,
480 cm2 if sample is < 0.5 mm thick, 32 grams, 5 mL, |
4-5 weeks |
| ST-NGLP-30 |
Kligman Maximization (30
tests) Polar and Non-Polar Extracts Included,
Non-GLP Compliant |
4-5 weeks |
| ST-GLP-35 |
Kligman Maximization (35
tests) Polar and Non-Polar Extracts Included,
GLP Compliant |
4-5 weeks |
| ST-NGLP-35 |
Kligman Maximization (35
tests) Polar and Non-Polar Extracts Included,
Non GLP Compliant |
4-5 weeks |
Irritation/Intracutaneous
- ISO 10993-10
Determines how irritable a product or compound
is to the body. Studies should be made in combination
with how the product or compound will be used
and effected areas should be tested to determine
the effect over time.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| IT-GLP |
Irritation Test -Intracutaneous
Injection Assay, Polar and Non-Polar Extracts
Included, GLP Compliant |
Sample
needed: 240 cm2 if sample is < 0.5 mm
thick, 120 cm2 if sample is > 0.5 mm
thick, 8 grams, 10 mL |
3-4 weeks |
| IT-NGLP |
Irritation Test -Intracutaneous
Injection Assay, Polar and Non-Polar Extracts
Included, Non-GLP Compliant |
3-4 weeks |
Acute
Systemic Toxicity - ISO 10993-11
Identifies the effect of being exposed to a product
or compound within 24 hours. Acute toxicity occurs
after a single exposure or repeated exposures
to the test subject. Subacute symptoms appear
within 14 to 28 days of delivery.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| SA-GLP |
Systemic Injection Assay-Polar
and Non-Polar Extracts Included, GLP Compliant |
240
cm2 if sample is < 0.5 mm thick,
120
cm2 if sample is > 0.5 mm thick,
8 grams, 10 mL |
4 weeks |
| SA-NGLP |
Systemic Injection Assay-Polar
and Non-Polar Extracts Included, Non-GLP
Compliant |
4 weeks |
Subchronic
Toxicity - ISO 10993-11
Studies that continue for 90 days or for up to
10% of a test subjects life span are considered
subchronic. Studies that continue for longer than
10% of a test subjects life span are considered
chronic.
Genotoxicity
- ISO 10993-3
Genotoxicity, tests for gene mutations, changes
in chromosomes, DNA and gene toxicities caused
by products or compounds.
Implantation
- ISO 10993-6
Studies the effects of products or compounds on
living tissue. Exaggerated amounts of material
should be used. It may be important to calculate
the maximum amount of material that would be typically
used and then implant multiples of that amount
in an experiment.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| IM-GLP |
Implantation-Implant/Muscle/1
-13 weeks, with Histopathological
Evaluations of test and sponsor supplied
controls, GLP compliant |
1-3mm
in width and 10mm in length |
1-13 weeks |
| IM-NGLP |
Implantation-Implant/Muscle/1
-13 weeks, with Histopathological
Evaluations of test and sponsor supplied
controls, Non-GLP compliant |
1-13 weeks |
Hemocompatibility
- ISO 10993-4
Tests the effects of blood contacting the product
or compounds on blood or blood components, directly
or indirectly during routine use.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| HE-GLP |
Hemocompatibility Tests
In
vitro or extract Hemocompatibility Assay,
GLP Compliant |
Sample
Needed: 360 cm2 if sample is < 0.5 mm
thick,
180cm2 if sample is < 0.5 mm thick,
10 grams |
3-5 weeks |
| HE-NGLP |
Hemocompatibility Tests
In
vitro or extract Hemocompatibility Assay,
Non-GLP Compliant |
3-5 weeks |
Chronic
Toxicity - ISO 10993-11
Chronic toxicity studies can require that animal
subjects be exposed to varying doses of test agents
over an extended period of time.
Carcinogenicity
- ISO 10993-3
This test should be performed only if there is
data from other sources suggesting possible difficulties.
This test is performed over the majority of the
test subjects life. It looks for tumorigenicity
as well as chronic toxicity.
Reproductive/Developmental
- ISO 10993-3
This study should only be performed when it is
believed that the reproduction system will be
affected by the product of compound. It tests
the effects of the product or compound on the
reproductive system, development of the embryo,
as well as pre and postnatal development.
Biodegradation
- ISO 10993-9
Tests how much of the product or compound is absorbed
by the body and follows the product or compound
through the body after it has been absorbed to
determine the effects over time.
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