ISO 10993-4 PDF

A statement that in certain cases a combination of coagulation, platelet assessments, hematology and complement could substitute for thrombosis testing. Only parts that are blood contacting direct and indirect should be tested. Controls should be used and if a predicate is available should be used. A decision tree is presented on when to conduct blood compatibility evaluations. All products must evaluate hemolysis.

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Test your medical device now This is how we test your medical device Request a quote - per telephone or online. Please provide the following information: What product would you like to test and which materials is it made of, if known. Once you have received our quote, send in your product. As soon as your product has arrived at our laboratory we will start the biocompatibility testing. We test your product as provided. Initially we usually perform cytotoxicity testing. If your product does not pass this test, further testing is not sensible.

You will receive a test report, as well as an evaluation. Our scientific director evaluates the results of the test reports. Biological tests according to the ISO standard series Hygcen offers all tests in of the ISO standard, which are not animal based in vivo tests.

We test guaranteed cruelty-free, hence no animal testing. In addition, we test medical devices in original delivery condition. This implies that our tests will also detect potential contamination due to production residues, foreign substances and migration from packaging material.

Your biocompatibility test plan should therefore focus on in vitro procedures. In vitro tests are rapid, animal friendly and low cost. These tests require a long time and incur high costs. If in vitro tests cannot fully assess the risk from a medical device, then in vivo tests become necessary. Implantable medical devices, or devices which come in contact with circulating blood, fall into this category.

In vivo tests are used for acute, subchronic and chronic toxicity testing, which are used to judge systemic toxicity and implantation. A well-developed biocompatibility test plan is essential for reducing, or even obviate, the need for in vivo tests HygCen tests without animal tests! The test procedures for biological evaluation The cytotoxicity test is a key test in the context of biocompatibility evaluation for your product. If your product cannot pass the cytotoxicity test any additional or follow-on test may not be sensible.

Test procedure: The cytotoxicity test has a basic procedure, but may vary in the endpoint which is being measure. In principle the test can be thought of as: The medical device or relevant components thereof are extracted in a suitable extraction medium. Cells in a cell culture are exposed to the medical device extract incubation.

After incubation the degree of cell survival is assessed. Depending on the degree of survival your medical device passes or fails the cytotoxicity test or put in another way: the medical device is or is not biocompatible according to the requirements laid out by EN ISO All medical devices, which are used for longer than 30 days, have to be tested for genotoxicity.

The cytotoxicity test is not a substitute for the genotoxicity test. Test procedure: Genotoxicity is assessed through two in vitro tests. Both tests are rapid, cost effective and straight-forward. The primary screening test is the Ames Bacterial Reversion Assay. This test utilizes special bacterial strains.

The bacteria cannot produce the essential amino acid histidine and are therefore dependent on exogenous histidine for their survival. However, the gene for producing histidine is present in the cell, but mutated to be defective. Through mutation the existing mutation can be reversed to make the histidine gene functional again.

The medical device is considered as not potentially genotoxic according to EN ISO if the extract from the medical device does not cause reverse mutations. If your medical device comes, directly or indirectly, in contact with the circulatory system, then it may have to be evaluated for hemocompatibility. These test attempt to assess if the medical device is likely to cause emboli or thrombi.

If so, then the device should definitely be prevented from being introduced into the market. Aside from chemical composition, the nature of the surface of the medical device can dramatically influence the interaction of the device with blood and blood components.

Test procedure: There are several affordable in vitro tests in the category of hemocompatibility. In general, these tests will be performed together in order to assess hemocompatibility. The tests are hemolysis, coagulation, and formation of the terminal complement complex TCC of the coagulation cascade. The hemocompatibility tests provide reliable results in order to determine if your device meets the requirements of EN ISO Medical devices, aids stockings and bandages , amongst others, need to be tested to be free of cellular toxicity and irritative potential.

If your medical device has passed the cytotoxicity test, the epicutan test may be a sensible follow-on test. This challenge test attempts to exclude the possibility that your medical device cause contact allergies. Test procedure: The epicutan test is actually an in vivo test, which utilizes volunteers.

Prior to entering into the epicutan test the medical device must have passed the cytotoxicity test. The medical device or an extract thereof is tested on the skin of human volunteers.

If your medical device does not cause skin irritation it is classified as skin biocompatible according to ISO This test is utilized to determine if your medical device is free from endtoxins and pyrogenic substances. Pyrogenic reactions fever reaction are usually caused by bacterial contamination. Endotoxins, also known as lipopolysaccharides, are components of the outer cell wall of certain bacteria.

The human immune system responds to endotoxins and as a consequence a fever may ensue. Test procedure: The endotoxin and pyrogen test are performed in vitro. The IPT In vitro pyrogen test can detect endotoxins and other pyrogenic substances, e. If your medical device is free from pyrogenic substances it is considered biocompatible according to EN ISO This makes sense if toxicologically relevant limits can be derived for the substances in the product.

Potentially further testing may not be necessary. This could advantageous for medical device manufacturers, as it could reduce cost and decrease time to market. Animal testing could perhaps become completely redundant. Packaging materials, from which compounds could migrate to the medical device Extractable chemical compounds Degradation products aging, manufacturing residues Other constituents and their interaction in the final product Additive contaminants from production, residue from the medical device, and purposely added additives What are the implications for biocompatibility testing of medical devices?

The chemical characterization of medical devices will be a major part of the biocompatibility und toxicological assessment based on EN ISO The importance of ever more complex chemical analysis will increase in order to identify and quantify unknown chemicals non-target substances.

We perform analysis according to national and international standards. Our test laboratory based in Schwerin employs highly trained employees, who are engaged in making medical devices safer for consumers worldwide. As a strong team we take pride in our integrity, impartiality, independence and confidentiality. We ask for your understanding! Request a quote for your product We assess the biocompatibility of your medical device Title:.


Prüfung von Medizinprodukten nach ISO 10993



ISO 10993-4



UNE EN ISO 10993-4:2018



ISO 10993-4:2002


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