Name: PREN ISO 15197 : DRAFT 2011
Brand: CEN

PREN ISO 15197 : DRAFT 2011

Superseded

IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS

Superseded date

05-01-2013

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
5 Information supplied by the manufacturer
6 Safety and reliability testing
7 Analytical performance evaluation
8 User performance evaluation
Annex A (normative) - Potential interferents
Annex B (informative) - Traceability chain
Annex C (informative) - Analytical performance
        requirements for self-monitoring of blood
        glucose for the control of diabetes mellitus
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EC Directive 98/79/EC
         In vitro diagnostic medical devices
Bibliography

Defines 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	TC 140
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 15197:2015

Standards	Relationship
11/30208525 DC : 0	Identical

ISO 5725-1:1994	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
CLSI C31 A2 : 2ED 2001	IONIZED CALCIUM DETERMINATIONS: PRE-COLLECTION VARIABLES, SPECIMEN CHOICE, COLLECTION, AND HANDLING
CSA Z316.4 : 0	PERFORMANCE SPECIFICATIONS FOR PORTABLE WHOLE BLOOD GLUCOSE MONITOR SYSTEMS FOR USE IN DIABETES MANAGEMENT
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
CLSI EP21 A : 1ED 2003	ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
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
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
ISO 18153:2003	In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
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)
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 13532:2002	General requirements for in vitro diagnostic medical devices for self-testing
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
ISO 14969:1999	Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488
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
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
ISO 3534-1:2006	Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
CLSI EP18 A2 : 2ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES