ISO 15198:2004

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

Publication date: 16 korr 2004

General information

Current stage: 90.60 Effective date: 4 mar 2024

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Gjuha: anglisht

Buying

Statusi: Publikuar

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Scope

ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.

Life cycle

NOW

PUBLISHED
ISO 15198:2004
90.60 Close of review
4 mar 2024

National adoptions

SSH ISO 15198:2007

DPS

Laboratorë të analizave të biologjisë mjeksore- 41 të diagnostikimit “in vitro” - Vlerësimi nga prodhuesi i procedurave të kontrollit të cilësisë të përdoruesit.

60.60 Standard published

DPS/KT 1 më tepër