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