ISO 15198:2004 PDF

Scope: This International Standard 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. This International Standard applies to all in vitro diagnostic medical devices.

ISO 15198:2004 Referenced Document

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 3534-1 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
ISO 5725-1 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions*， 2023-07-01 Update

2004 ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer