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CEN

CEN/TC 140/WG 8 - IVDs for self-testing

To elaborate standards for WI 00140042 and WI 00140043.

IVDs for self-testing

To elaborate standards for WI 00140042 and WI 00140043.

General Information

Status
Inactive
Parent
CEN/TC 140 - In vitro diagnostic systems

Frequently Asked Questions

CEN/TC 140/WG 8 is a Working Group within the European Committee for Standardization (CEN). It is named "IVDs for self-testing" and is responsible for: To elaborate standards for WI 00140042 and WI 00140043. This committee has published 5 standards.

CEN/TC 140/WG 8 develops CEN standards. The scope of work includes: To elaborate standards for WI 00140042 and WI 00140043. Currently, there are 5 published standards from this working group.

The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.

A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.

Standardization Organization
ICS
Directive
Mandate
50
CEN
EN ISO 15197:2015(Main)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
SIST EN ISO 15197:2015

ISO 15197:2013 specifies 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. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
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.

  • Standard
    57 pages
    English language
    e-Library read for
    1 day
CEN
EN 13532:2002(Main)
General requirements for in vitro diagnostic medical devices for self-testing
SIST EN 13532:2002

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.

  • Standard
    8 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 15197:2013(Main)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
SIST EN ISO 15197:2013

2012-10-30 GVN: // vote draft provided to ISO/CS according to notification received in dataservice on 2012-10-29
2011-08-24 EMA: DOW = DAV + 36 months (see confirmation from PM sent to dataservice on 2011-08-24).
2010-11-17 EMA: // ENQ draft provided to ISO/CS according to notification received in dataservice on 2010-11-12.

  • Standard
    56 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 15197:2003/AC:2005(Corrigendum)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
SIST EN ISO 15197:2003/AC:2005

TC - Removal of one reference in Annex Z

  • Corrigendum
    2 pages
    English, French and German language
    e-Library read for
    1 day
CEN
EN ISO 15197:2003(Main)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
SIST EN ISO 15197:2003

ISO 15197:2003 specifies 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. These systems are intended for self-testing by laypersons for management of diabetes mellitus.
ISO 15197:2003 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.
ISO 15197:2003 does not provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; does not pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus; does not address the medical aspects of diabetes mellitus management; does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

  • Standard
    37 pages
    English language
    e-Library read for
    1 day
50