IME-DC iDia - List of Items and Quality Standards

To Next Page

To Previous Page

TABLE OF CONTENTS

LIST OF ITEMS | QUALITY STANDARDS

List of items EAN code

iDia IME-DC blood glucose monitoring system set (mg/dL) 4260155930171

iDia IME-DC blood glucose monitoring system set (mmo/L) 4260155930201

iDia IME-DC blood glucose test strips 4260155930188

iDia IME-DC control solution (level 1/level 2) 4260155930195

IME-DC lancing device 4260155930065

IME-DC UNIVERSAL blood lancets 4260155930058

IME-DC USB data cable 4260155930041

3 V lithium battery (CR 2032) 4260155930072

Quality standards

■ Directive 98/79/EC of the European Parliament and of the Council

of 27 October 1998 on in vitro diagnostic medical devices

■ EN 60601-1/IEC 60601-1: Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance

■ EN 60601-1-2/IEC 60601-1-2: Medical electrical equipment –

Part 1-2: General requirements for basic safety and essential

performance - Collateral standard: Electromagnetic disturbances

- Requirements and tests

■ EN 61010-1/IEC 61010-1: Safety requirements for electrical

equipment for measurement, control, and laboratory use - Part 1:

General requirements

■ DIN EN ISO 15197: In vitro diagnostic test systems – Requirements

for blood-glucose monitoring systems for self-testing in managing

diabetes mellitus