SSH EN 592:2004

Instruksionet që përdoren për instrumentat e diagnostikimit in vitro për vetëtestim

Instructions for use for in vitro diagnostic instruments for self-testing

Publication date: 1 jan 2004

95.99 Withdrawal of Standard 13 maj 2015

General information

Current stage: 95.99 Effective date: 13 maj 2015

Originator: DPS

Owner: DPS/KT 140

Type: European Norm

ICS: 11.100

Gjuha: anglisht

Buying

Statusi: Shfuqizuar

PDF - 1 963 Lekë

Paper - 1 963 Lekë

CD - 1 963 Lekë

PDF and Paper - 3 926 Lekë

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Scope

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.

NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.

NOTE 2 This standard can also be applied to accessories.

This standard is not applicable to field repair instructions.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara

Directive 98/79/EC

Life cycle

NOW

WITHDRAWN
SSH EN 592:2004
95.99 Withdrawal of Standard
13 maj 2015

REVISED BY

PUBLISHED
SSH EN ISO 18113-5:2011

SSH EN 592:2004

Instruksionet që përdoren për instrumentat e diagnostikimit in vitro për vetëtestim

Instructions for use for in vitro diagnostic instruments for self-testing

95.99 Withdrawal of Standard 13 maj 2015

General information

Buying

Scope

Related directives

Life cycle

NOW

REVISED BY

Related project

Adopted from EN 592:2002