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NEN EN ISO 15197 : 2015

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
Published date

12-01-2013

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

Defines requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
DIN EN ISO 15197:2015-12 Identical
UNE-EN ISO 15197:2015 Identical
EN ISO 15197:2015 Identical
ISO 15197:2013 Identical
UNI EN ISO 15197 : 2013 Identical
BS EN ISO 15197:2015 Identical
I.S. EN ISO 15197:2015 Identical

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