prEN ISO 15197 rev

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus prEN ISO 15197 rev

General information

10.99 New project approved   Dec 20, 2024

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

Scope

<p>ISO 15197:2013 specifies requirements for <em>in vitro</em> 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. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.</p>
<p>ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.</p>

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15197:2015

IN_DEVELOPMENT
EN ISO 15197:2015/prA11

NOW

IN_DEVELOPMENT
prEN ISO 15197 rev
10.99 New project approved
Dec 20, 2024