DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN 455-3:2023

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

Jul 11, 2024

General information

60.60     Jul 11, 2024

DPS

DPS/KT 205

European Norm

11.140  

English  

Buying

Published

Language in which you want to receive the document.

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

Directives related to this standards.

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
Directive 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 455-3:2015

NOW

PUBLISHED
SSH EN 455-3:2023
60.60 Standard published
Jul 11, 2024

Related project

Adopted from EN 455-3:2023