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In the European standard EN 455-3, the requirements for the biological evaluation of disposable medical gloves are explained and test methods are presented. This standard, which is a set of standards, has been published by the Turkish Standards Institute in our country with the following headings:
The EN 455-3 standard includes test procedures for measuring endotoxin contamination of sterile gloves, dust residue for powder-free gloves, and leachable proteins in natural rubber latex gloves.
Quality and strength of disposable medical glovesBiological evaluation tests are important in determining the suitability. In this way, accurate information is obtained about the effects of various materials used in production. In this way, negativities are determined in the design and development processes and deviations are prevented. In most cases, risk analysis is supported by computer simulations.
Various reactions against proteins are encountered in latex products. Also known are reactions from chemicals, lubricants, sterilization residues, pyrogens or other residues. Adverse reactions are most common in gloves made of natural rubber latex. However, some reactions are also seen in gloves made of synthetic polymers. The ENs ISO 10993 standard contains requirements and test methods for biological evaluations. However, it does not specifically address reactions from the use of medical gloves. Such reactions occur with specific allergens found in gloves.
In this regard, the EN 455-3 standard helps to evaluate the biological safety of medical gloves as part of a risk management process in accordance with the EN ISO 10993 standard.
With the experience gained over many years, our organization also provides biological evaluation testing services for EN 455-3 disposable medical gloves within the framework of laboratory services of the materials with a trained and expert staff.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
Our organization operates in a nationally and internationally approved, independent and impartial manner, in order to increase the product quality of enterprises and to prevent possible commercial risks in international trade. It provides audit, surveillance, inspection, testing, measurement and analysis services for businesses of all sectors and sizes, evaluates, reports and documents.
