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)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
TC - Removal of one reference in Annex Z
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung beim Diabetes mellitus (ISO 15197:2003)
Systèmes d'essais de diagnostic in vitro - Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré (ISO 15197:2003)
Diagnostični preskusni sistemi in vitro - Zahteve za sisteme spremljanja glukoze v krvi za samopreskušanje pri obravnavi sladkorne bolezni (ISO 15197:2003)
General Information
- Status
- Withdrawn
- Publication Date
- 08-Mar-2005
- Withdrawal Date
- 21-May-2013
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140/WG 8 - IVDs for self-testing
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 22-May-2013
- Completion Date
- 22-May-2013
Relations
- Effective Date
- 29-May-2013
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 15197:2003/AC:2005 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)". This standard covers: TC - Removal of one reference in Annex Z
TC - Removal of one reference in Annex Z
EN ISO 15197:2003/AC:2005 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15197:2003/AC:2005 has the following relationships with other standards: It is inter standard links to EN ISO 15197:2013, EN ISO 15197:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15197:2003/AC:2005 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 15197:2003/AC:2005 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2005
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR=DKWHYH]DVLVWHPHVSUHPOMDQMDJOXNR]HY
NUYL]DVDPRSUHVNXãDQMHSULREUDYQDYLVODGNRUQHEROH]QL ,62
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus (ISO 15197:2003)
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur
Eigenanwendung beim Diabetes mellitus (ISO 15197:2003)
Systemes d'essais de diagnostic in vitro - Exigences relatives aux systemes
d'autosurveillance de la glycémie destinés a la prise en charge du diabete sucré (ISO
15197:2003)
Ta slovenski standard je istoveten z: EN ISO 15197:2003/AC:2005
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15197:2003/AC
NORME EUROPÉENNE
March 2005
Mars 2005
EUROPÄISCHE NORM
März 2005
ICS 11.040.55
English version
Version Française
Deutsche Fassung
In vitro diagnostic test systems - Requirements for blood-glucose
monitoring systems for self-testing in managing diabetes mellitus (ISO
15197:2003)
Systèmes d'essais de diagnostic in vitro - Testsysteme für die In-vitro-Diagnosti
...
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