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

ISO 18113-5:2022

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

Oct 6, 2022

General information

60.60     Oct 6, 2022

ISO

ISO/TC 212

International Standard

11.100.10  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 18113-5:2009

NOW

PUBLISHED
ISO 18113-5:2022
60.60 Standard published
Oct 6, 2022

National adoptions

SSH ISO 18113-5:2022  
DPS

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

60.60 Standard published

DPS/KT 140 more