MEDICAL DEVICES

Genotoxicity and Carcinogenicity of a Medical Device 10993-3

Tests to be performed in accordance with ISO
10993-3 Standard
• Test for Gene Mutation in Bacteria (Test a)
• One possible test is Bacterial Mutagenicity assays
• The method for above test is :
• Plate incorporation assay in which Salmonella typhimurium LT2 and
E.Coli WP2 strains is a short term bacterial reverse mutation assay
specifically designed to detect a wide range of chemical substances
capable of causing DNA damage leading to gene mutations.
• Above test is employed worldwide in order to assess the mutagenic
potential of new chemicals and drugs.
Tests to be performed in accordance with ISO
10993-3 Standard
• Test for Gene mutation in Mammalian Cells (Test b)
• Hypoxanthine phophorybosyl transferase (HPRT) gene is on the X-
Chromosome of mammalian cells and it is used as model gene
mutation in mammalian cells.
• The HPRT methodology is such that mutations which destroy the
functionality of the HRPT Gene are detected by positive selection.
• HRPT – mutants will be grown as viable colonies.
• Above mentioned tests are all in-vitro tests.
 Carcinogenicity of a medical Device
• Carcinogenicity testing shall be performed in the following cases:
• Resorbable materials and medical devices for which the resorption
time is greater then 30 days.
• Materials and medical devices introduced in the body or in its cavities
with a permanent or cumulative contact of greater than 30 days.
• When according to 10993-1 chronic toxicity and carcinogenicity have
been considered and is necessary to be performed.
• The study will be performed on only one animal.
Reproductive and Developmental Toxicity
Tests (Done through OECD Test No. 421)
• These tests are performed on the following:
• Prolonged or permanent contact devices likely to come into direct
contact with the reproductive system or embryo/fetus.
• Energy depositing medical devices
• Resorbable or leachable materials
• All of the studies are conducted on animals.
• But in vitro reproductive test systems are also available.