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 ISO 18113-5:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Mar 29, 2012
95.99 Withdrawal of Standard   Jun 25, 2025

General information

95.99     Jun 25, 2025

DPS

DPS/KT 140

European Norm

11.100.10  

English  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 592:2004

NOW

WITHDRAWN
SSH EN ISO 18113-5:2011
95.99 Withdrawal of Standard
Jun 25, 2025

REVISED BY

PUBLISHED
SSH EN ISO 18113-5:2024

Related project

Adopted from EN ISO 18113-5:2011