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
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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
|
| Standards | Relationship |
| ISO 15197:2013 | Identical |
| NS EN ISO 15197 : 2015 | Identical |
| NF EN ISO 15197 : 2015 | Identical |
| NEN EN ISO 15197 : 2015 | Identical |
| I.S. EN ISO 15197:2015 | Identical |
| SN EN ISO 15197 : 2015 | Identical |
| UNE-EN ISO 15197:2015 | Identical |
| UNI EN ISO 15197 : 2013 | Identical |
| BS EN ISO 15197:2015 | Identical |
| EN ISO 15197:2015 | Identical |
| NBN EN ISO 15197 : 2015 | Identical |
| 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 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 |
| 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 including Technical Corrigendum 1:2001) |
| 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 5725-1:1994) |
| 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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