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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ISO 10993-3 specifies strategies for

hazard identification and tests on medical

devices.

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ISO 10993-3 specifies strategies for

hazard identification and tests on medical

devices.

Genotoxicity

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ISO 10993-3 specifies strategies for

hazard identification and tests on medical

devices.

Genotoxicity

Carcinogenicity

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ISO 10993-3 specifies strategies for

hazard identification and tests on medical

devices.

Genotoxicity

Carcinogenicity

Reproductive and Developmental Toxicity

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Genotoxicity

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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

You can view the entire ISO 10993 Series here

For information about the services NAMSA can offer you regarding genotoxicity, carcinogenicity and reproductive toxicity

Visit our Biocompatibility page, or

Download our Biocompatibility brochure

For additional information

Contact us at clientcare@namsa.com.