Abstract

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. Compared to the first draft, CEN/TC 205/WG 3 decided to specify only one reference test method to provide a simple and clear standard and a better comparability. In addition, the labelling requirements were deleted from the scope of prEN 455-5:2024.

Begin

2022-05-10

WI

00205352

Planned document number

DIN EN 455-5

Project number

06301953

Responsible national committee

NA 176-04-09 AA - Medical gloves for single use  

Responsible european committee

CEN/TC 205/WG 3 - Medical gloves  

draft standard

Medical gloves for single use - Part 5: Extractable chemical residues; German and English version prEN 455-5:2023
2023-04
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Medical gloves for single use - Part 5: Extractable chemical residues; German and English version prEN 455-5:2024
2024-08
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