logo

Standards Manage Your Business

We Manage Your Standards

ISO

ISO 15198:2004

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 15198:2004
Document Year: 2004
Pages: 10
Edition: 1
  • Section Volume:
  • ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems
  • ICS:
  • 11.100.10 In vitro diagnostic test systems

Life Cycle

Currently Viewing

Published
ISO 15198:2004
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +