ISO 10993-3: Biological Evaluation of Medical Devices discusses how to identify when genotoxicity, carcinogenicity or reproductive toxicity testing is necessary for a medical device.

1. ISO 10993-3
Biological evaluation of medical devices –
Tests for genotoxicity, carcinogenicity and
reproductive toxicity
Melissa Cadaret, MS
Director, Biocompatibility
NAMSA
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2. 2
ISO 10993-3 specifies strategies for
hazard identification and tests on medical
devices.

3. 3
ISO 10993-3 specifies strategies for
hazard identification and tests on medical
devices.
Genotoxicity

4. 4
ISO 10993-3 specifies strategies for
hazard identification and tests on medical
devices.
Genotoxicity
Carcinogenicity

5. 5
ISO 10993-3 specifies strategies for
hazard identification and tests on medical
devices.
Genotoxicity
Carcinogenicity
Reproductive and Developmental Toxicity

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Genotoxicity

7. 7
Genotoxicity
These types of tests are designed to detect
two major classes of genetic damage

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Genotoxicity
These types of tests are designed to detect
two major classes of genetic damage:
Gene Mutation

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Genotoxicity
These types of tests are designed to detect
two major classes of genetic damage:
Gene Mutation
Chromosomal damage

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Genotoxicity
There is no single test capable of detecting
all relevant genotoxic agents; therefore, the
usual approach is a testing battery.

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Genotoxicity
Test Battery
Test for gene mutation in bacteria

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Genotoxicity
Test Battery
Test for gene mutation in bacteria
And either
In vitro mammalian test with cytogenetic
evaluation of chromosomal damage

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Genotoxicity
Test Battery
Test for gene mutation in bacteria
And either
In vitro mammalian test with cytogenetic
evaluation of chromosomal damage
Or
In vitro mouse lymphoma tk assay

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Genotoxicity
Test Battery
Test for gene mutation in bacteria
And either
In vitro mammalian test with cytogenetic
evaluation of chromosomal damage
Or
In vitro mouse lymphoma tk assay
Or
In vitro mammalian cell micronucleus test
for chromosomal damage

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Carcinogenicity

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Carcinogenicity
These types of tests assess tumorigenic
potential

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Carcinogenicity
This testing is required
When carcinogenic risk cannot be ruled
by risk analysis

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Carcinogenicity
This testing is required
When carcinogenic risk cannot be ruled
by risk analysis
For materials which degradation time is
greater than 30 days

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Carcinogenicity
This testing is required
When carcinogenic risk cannot be ruled
by risk analysis
For materials which degradation time is
greater than 30 days
For devices introduced in the
body/cavities with a permanent or
cumulative contact of greater than 30
days.

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Reproductive and Developmental Toxicity

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Reproductive and Developmental Toxicity
These tests evaluate the effects on
reproductive function, teratogenicity.

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Reproductive and Developmental Toxicity
Requirement for testing is limited to certain
devices

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Reproductive and Developmental Toxicity
Requirement for testing is limited to certain
devices
IUDs, or other devices in long-term
contact with reproductive tissues or
embryo/fetus

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Reproductive and Developmental Toxicity
Requirement for testing is limited to certain
devices
IUDs, or other devices in long-term
contact with reproductive tissues or
embryo/fetus
Energy depositing devices

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Reproductive and Developmental Toxicity
Requirement for testing is limited to certain
devices
IUDs, or other devices in long-term
contact with reproductive tissues or
embryo/fetus
Energy depositing devices
Resorbable or leachable material/devices
without adequate reproductive toxicity
data

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 To view the complete presentation on ISO
10993-3
 Check out NAMSA’s Seminars
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Series here
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can offer you regarding genotoxicity,
carcinogenicity and reproductive toxicity
 Visit our Biocompatibility page, or
 Download our Biocompatibility brochure
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 Contact us at clientcare@namsa.com.