prEN 455-5

Medical gloves for single use - Part 5: Extractable chemical residues prEN 455-5

Publication date:   Apr 13, 2023

General information

30.99 CD approved for registration as DIS   May 10, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

Buying

Draft

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Scope

This document specifies test methods for the measurement of residual chemicals used in products, 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.

Life cycle

NOW

IN_DEVELOPMENT
prEN 455-5
30.99 CD approved for registration as DIS
May 10, 2024