ISO 15198 : 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

Abstract - (Show below) - (Hide below)

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

General Product Information - (Show below) - (Hide below)

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 212
Supersedes	ISO/DIS 15198 : 60.00 (2004)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
BS ISO 15198 : 2004	Identical
DS ISO 15198 : 2004	Identical
GOST R ISO 15198 : 2009	Identical
NEN ISO 15198 : 2004	Identical
NBR NM-ISO 15198 : 2008 ERRATA 2011	Identical
NEN ISO 15198 : 2004	Identical
BS ISO 15198 : 2004	Identical
DS ISO 15198 : 2004	Identical
NBR NM-ISO 15198 : 2008 ERRATA 2011	Identical
GOST R ISO 15198 : 2009	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

DIN EN ISO 18113-1 : 2013	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
BS ISO 17593 : 2007	CLINICAL LABORATORY TESTING AND IN VITRO MEDICAL DEVICES - REQUIREMENTS FOR IN VITRO MONITORING SYSTEMS FOR SELF-TESTING OF ORAL ANTICOAGULANT THERAPY
BS EN ISO 18113-1 : 2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
CSA ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
06/30146526 DC : 0	BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
06/30146522 DC : 0	BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
ISO 17593 : 2007	CLINICAL LABORATORY TESTING AND IN VITRO MEDICAL DEVICES - REQUIREMENTS FOR IN VITRO MONITORING SYSTEMS FOR SELF-TESTING OF ORAL ANTICOAGULANT THERAPY
DIN EN ISO 18113-1 E : 2013	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
06/30146518 DC : 0	BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
I.S. EN ISO 18113-1:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
06/30146515 DC : 0	BS ISO 18113-2 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
06/30146511 DC : 0	BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
UNI CEI EN ISO 14971 : 2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI ISO 14971 : 2007 : R2010	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2017	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2017	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNI EN ISO 18113-1 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
AAMI ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNE EN ISO 18113-1 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
ISO 18113-1 : 2009(R2015)	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
CEI UNI EN ISO 14971 : 2013	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

Standards Referencing This Book - (Show below) - (Hide below)

ISO 5725-1 : 1994(R2018)	ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
ISO 15194 : 2009(R2015)	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(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
MIL STD 1629 : A	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(R2010)	STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY

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