prEN 455-5

Medical gloves for single use - Part 5: Extractable chemical residues

Publication date:   Aug 1, 2024

General information

40.60 Close of voting   Oct 24, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on the extraction vehicle, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

Life cycle

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prEN 455-5
40.60 Close of voting
Oct 24, 2024