Ehdotuksen tiedot

This document provides requirements for label information about chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on extraction media, methods of extraction and quantitative assay of residual chemicals. This document does not provide information on the allergenic potential or safety to the user of any product. This is expected to be assessed in the light of all available toxicity and biocompatibility data on the products concerned as part of a risk management process.