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BS ISO 15198:2004

Current
Current

The latest, up-to-date edition.

Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

23-07-2004

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality control procedures
5 Validation of quality control procedures
6 Recommendations to users
Bibliography

Specifies a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users.

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.

Committee
CH/212
DevelopmentNote
Supersedes 01/561495 DC. (08/2004)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 15198:2004 Identical

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10005:2005 Quality management systems Guidelines for quality plans
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
MIL-STD-1629 Revision A:1980 PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS
CLSI C24 A : 1991 INTERNAL QUALITY CONTROL TESTING: PRINCIPLES AND DEFINITIONS
CLSI EP18 A : 1ED 2002 QUALITY MANAGEMENT FOR UNIT-USE TESTING
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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