TS EN 455-3 is the standard for the biological evaluation of disposable medical gloves. This standard is used to determine whether medical gloves protect against biological risks that could potentially harm human health during use.
We can summarize the main topics and test procedures within the scope of TS EN 455-3 below:
1. **Endotoxin Test:** This test determines whether gloves contain bacterial endotoxins that potentially cause fever and inflammation.
2. **Chromatin Sensitization Test:** This test is done to check whether the gloves cause allergic reactions in the wearer, this is a concern especially with latex gloves.
3. **Cytotoxicity Test:** This test determines whether the gloves cause cellular toxicity. That is, it is done to find out whether the glove material harms the cells.
4. **Viral Barrier Test:** This test evaluates whether gloves act as a barrier against certain viruses.
5. **Evaluation of Results:** The test results are compared with the requirements specified in the standard. This is used to evaluate how effectively the gloves protect the wearer against biohazards.
Biological evaluation is a critical step in determining whether medicinal products are safe for users. TS EN 455-3 is used to evaluate whether medical gloves comply with these safety standards.