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DIN EN ISO 15197:2015-12

Current
Current

The latest, up-to-date edition.

IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2015

National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
5 Safety and reliability testing
6 Analytical performance evaluation
7 Information supplied by the manufacturer
8 User performance evaluation
Annex A (informative) - Possible interfering substances
Annex B (informative) - Traceability chain
Annex C (informative) - Rationale for the analytical
         performance requirements
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 98/79/EC
Bibliography

This standard is included in DIN Handbook 378.

DevelopmentNote
DIN EN ISO 15197 issue 11-2013 remains valid alongside this standard until 30-06-2018. (12/2015)
DocumentType
Standard
Pages
56
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

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DIN HDBK 378 : 3ED 2014
DIN EN ISO 18113-2:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
DIN EN 61326-2-6 : 2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012)
DIN EN ISO 23640:2015-12 IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
DIN ISO 5725-2:2002-12 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method (ISO 5725-2:1994 including Technical Corrigendum 1:2002)
DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
DIN EN ISO 17511:2003-11 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
DIN EN 61326-1 : 2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 1: GENERAL REQUIREMENTS (IEC 61326-1:2012)
DIN EN 60068-2-64 : 1995 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
DIN ISO 3534-1:2009-10 STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
DIN EN 62366 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
DIN ISO 5725-3:2003-02 ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 3: INTERMEDIATE MEASURES OF THE PRECISION OF A STANDARD MEASUREMENT METHOD
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
DIN EN ISO 18113-4:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
DIN ISO 5725-1:1997-11 ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
DIN EN 61010-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
DIN EN ISO 15194:2009-10 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)

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