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
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.
- Standard57 pagesEnglish languagee-Library read for1 day
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.
- Standard8 pagesEnglish languagee-Library read for1 day
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.
- Standard56 pagesEnglish languagee-Library read for1 day
TC - Removal of one reference in Annex Z
- Corrigendum2 pagesEnglish, French and German languagee-Library read for1 day
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).
- Standard37 pagesEnglish languagee-Library read for1 day
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.