EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of ISO 12243 testing. ISO 12243 specifies a method for determining the amount of water extractable protein in natural rubber (NR) gloves for medical use.
The method is potentially suitable for the determination of extractable protein in other articles made from NR latex; however, extraction procedures and times have not been validated and will vary depending on the type of product to be tested. Other methods for determining specific proteins in medical gloves are available (these are described in the appendix), but these do not have general applicability.
This International Standard relates only to the method of analysis. It does not relate to sampling and does not purport to address the safety implications of the values obtained or labeling requirements.
Water-soluble proteins are extracted into a buffer solution and then precipitated to concentrate and separate them from other water-soluble substances that may interfere with detection. The precipitated protein is redissolved and measured colorimetrically by the modified Lowry method using a protein standard.
The entire surface of the glove should be exposed to the extractant at 120°C ± 5°C for 25 minutes ± 5 minutes. Two extraction procedures are allowed, the so-called "glove cutting" procedure and also the "glove-in-glove" procedure. The procedure used should be stated in the test report and all samples in a given batch should be extracted by the same procedure. The extraction will be carried out in triplicate and single determinations will be made on each extract.
EUROLAB assists manufacturers with ISO 12243 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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