UNE-EN ISO 15197:2015
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)
Hardcopy , PDF
Spanish, Castilian, English
23-09-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
4.1 General requirements
4.2 Safety
4.3 Traceability
4.4 Ergonomic/human factor aspects
4.5 Risk analysis
4.6 User verification
5 Information supplied by the manufacturer
5.1 Labels for the blood-glucose meter
5.2 Instructions for use for the blood-glucose monitoring
system
5.3 Labels for the reagent system and control material
5.4 Instructions for use for reagents and control material
6 Safety and reliability testing
6.1 General requirements
6.2 Protection against electric shock
6.3 Protection against mechanical hazards
6.4 Electromagnetic compatibility
6.5 Resistance to heat
6.6 Resistance to moisture and liquids
6.7 Protection against liberated gases, explosion and
implosion
6.8 Meter components
6.9 Performance test
6.10 Mechanical resistance to shock, vibration and impact
6.11 Equipment temperature exposure limits
6.12 Equipment humidity exposure test protocol
6.13 Reagent storage and use testing
7 Analytical performance evaluation
7.1 General requirements
7.2 Precision evaluation
7.3 System accuracy evaluation
7.4 Minimum acceptable system accuracy
8 User performance evaluation
8.1 General
8.2 Evaluation sites
8.3 User evaluation
8.4 Evaluation for instructions for use
Annex A (normative) Additional requirements for electromagnetic
compatibility
Annex B (informative) Traceability chain
Bibliography
Gives requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users.
Committee |
CTN 129
|
DocumentType |
Standard
|
Pages |
60
|
PublisherName |
Asociacion Espanola de Normalizacion
|
Status |
Current
|
Supersedes |
Standards | Relationship |
ISO 15197:2013 | Identical |
NF EN ISO 15197 : 2015 | Identical |
NBN EN ISO 15197 : 2015 | Identical |
NEN EN ISO 15197 : 2015 | Identical |
NS EN ISO 15197 : 2015 | Identical |
I.S. EN ISO 15197:2015 | Identical |
SN EN ISO 15197 : 2015 | Identical |
UNI EN ISO 15197 : 2013 | Identical |
BS EN ISO 15197:2015 | Identical |
EN ISO 15197:2015 | Identical |
DIN EN ISO 15197:2015-12 | Identical |
ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
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 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) |
ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
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 |
CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
EN 60068-2-64:2008 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
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 |
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 |
ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
EN 61326-1:2013 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
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 |
EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
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 |
CLSI C53 P : 1ED 2008 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
EN 61010-1:2010 | 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 |
EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
EN ISO 17511:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
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