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SRPS EN 455-5:2025

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

Dec 31, 2025

General information

60.60     Dec 31, 2025

ISS

Z076

European Norm

11.140  

English  

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Scope

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Directive 2017/745

Life cycle

NOW

PUBLISHED
SRPS EN 455-5:2025
60.60 Standard published
Dec 31, 2025

Related project

Adopted from EN 455-5:2025 IDENTICAL