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SRPS EN 455-3 :2024

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Apr 30, 2024

General information

60.60     Apr 30, 2024

ISS

Z076

European Norm

11.140  

English  

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Scope

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

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

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 455-3:2015

NOW

PUBLISHED
SRPS EN 455-3 :2024
60.60 Standard published
Apr 30, 2024

Related project

Adopted from EN 455-3:2023