BS ISO 15198:2004
Current
The latest, up-to-date edition.
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
Hardcopy , PDF
English
23-07-2004
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 01/561495 DC. (08/2004)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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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