Types of Medical Device Cytotoxicity Testing - ISO 10993-5

#1
How many types of cytotoxicity test are available for medical device testing . ISO 10993-5:1999 - Biological evaluation of medical devices

what are the difference between Plating Efficiency/Colony forming cytotoxicity test and Cell growth Analysis via BCA Staining (L929 cells).

If a medical device comes an indirect contact with blood of patient what type of cytotoxicity testing is preferanble in oder to gain CE in Europe.

Please a quick reply would be appriciable
 
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M

MIREGMGR

#2
I suggest you call some of the more prominent medical product testing laboratories in your area, and discuss this question with them.

They are likely to have a better comparative procedural knowledge than most of us, because they work with many manufacturers to specifically address that regulatory question for a wide variety of product types and materials.
 

bio_subbu

Super Moderator
#3
How many types of cytotoxicity test are available for medical device testing . ISO 10993-5:1999 - Biological evaluation of medical devices

what are the difference between Plating Efficiency/Colony forming cytotoxicity test and Cell growth Analysis via BCA Staining (L929 cells).

If a medical device comes an indirect contact with blood of patient what type of cytotoxicity testing is preferanble in oder to gain CE in Europe.

Please a quick reply would be appriciable
There are two types of cytotoxicity testing as per the Standard ISO 10993 such as cytotoxicity test by extract method and cytotoxicity test by direct method.

1. Cytotoxicity test by extract method:

Examples of cytotoxicity test methods using extracts include:
a) Fluid Medium Tissue Culture Assay
b) Inhibition of Cell Growth Assay
c) Cloning Efficiency Assay.

Fluid Medium tissue culture Assay:

Fluid Medium Tissue Culture evaluates the cellular damage caused by the test extract on a confluent monolayer culture. The text extract is incorporated into the culture medium which is usually double strength (2×) Minimum Essential medium supplemented with serum and other essential nutrients at the maintenance level. The toxic effect on the monolayer, such as cell lysis and microscopic observation of cell morphology changes, is usually checked after 24 and 48 hours. Cell lysis can be scored by direct microscopic observation or with the use of radiolabels or tryphan blue dye uptake.

Inhibition of cell Growth Assay

The inhibition of cell growth is a more informative test requiring more time and skill. Distilled water extract is incorporated into the tissue culture medium and inoculated with the cells in the tissue culture tubes. After 72 hours, the extent of cell growth is determined by total protein assay, such as the Lowery photometric method, on the removed cells from the individual tubes.

Cloning Efficiency Assay:

The Cloning Efficiency Assay is more informative, sensitive, and quantitative and requires even more skill. The Cloning Efficiency Assay’s procedure and endpoint is similar, but is more accurate, sensitive, and direct than Cell Growth Inhibition or Fluid Medium methods. The Cloning Efficiency assay normally uses a Chinese Hamster Ovary cell line and a single-cell cloning technique to estimate the toxic insult induced in cloning efficiency. The number of cells in The initial inoculum is considerably less than those plated to get confluent cultures (approximately 1 × 105 or less cells in a 100 × 15 mm Petri dish, compared to 1 × 106 or more cells).The initial inoculam are incubated for approximately 24 hours before these growing cells are treated with the tissue culture medium containing the test extract. The cytotoxic effect of the extract is determined by measuring the ability of the treated cells to form colonies during seven subsequent days of incubation. The cloning efficiency of the treated cultures is compared to that of the control. The agar overlay method can be used to evaluate the toxicity of the extracts, but it is primarily used for the direct contact cytotoxicity tests of the solid test sample.

2. Cytotoxicity test by direct method:

Several tests are available to test cytotoxicity by direct contact please refer below ASTM standards and guidelines;

1. ASTM F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

2. ASTM F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

3. ASTM F1027 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

I don’t know exactly what type of testing required by indirect contact with blood of patient, for more details discuss with any of the biocompatibility testing centre in your country.

Thanks and Regards
S. Subramaniam
 
D

devicenewby

#5
Hi,
I'm new to this forum and new to devices. This review on cytotox testing was very helpful.
I am working with iontophoretic devices. I'm guessing I will need to use an MEM elution method for testing. How do I figure out what to elute the device with and how long should the elution be incubated with the cells, 24, 48 or 72 hrs?
Thanks!
 
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