EN 376:1992
(Main)In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing
In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing
This standard specifies requirements for the labelling of in-vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use. The term "self-testing" intends both patient self-testing (i.e. home-testing carried out by patients under the supervision of their physician) and consumer self-testing (i.e. testing carried out by the lay public on their own initiative).
In-vitro-Diagnostik/Diagnostika - Kennzeichnung und Produktinformationen von In-vitro-Diagnostika für den Gebrauch durch Laien
Diese Norm führt Anforderungen an die Kennzeichnung und Produktinformationen von In-vitro-Diagnostica für den Gebrauch bei Selbsttesten, d.h. durch Laien, auf. Der Begriff "Selbsttesten" schliesst sowohl das Selbsttesten durch den Patienten (d.h. das Testen durch die Patienten zu Hause unter Überwachung durch ihren Arzt) als auch das Testen durch andere Anwender (d.h. das Testen durch Laien auf eigene Initiative) ein.
Systèmes d'analyses médicales in vitro - Etiquetage des réactifs pour le diagnostic pour l'utilisation comme auto-test
Cette norme précise les exigences applicables à l'étiquetage des réactifs pour le diagnostic in vitro qui sont destinés à l'utilisation comme "autotest" c.à.d.pour utilisation par des profanes. Le terme "autotest" comprend aussi bien l'usage par un patient (c.à.d. les tests effectués à domicile par des patients sous le contrôle de leur médecin) que par un consommateur (c.à.d. les tests effectués par un public profane de sa propre initiative).
Diagnostični sistemi in vitro - Zahteve za označevanje diagnostičnih reagentov in vitro za samopreskušanje
General Information
- Status
- Withdrawn
- Publication Date
- 28-May-1992
- Withdrawal Date
- 12-Feb-2002
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140/WG 1 - Labelling and performance evaluation
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 13-Feb-2002
- Completion Date
- 13-Feb-2002
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 376:1992 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing". This standard covers: This standard specifies requirements for the labelling of in-vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use. The term "self-testing" intends both patient self-testing (i.e. home-testing carried out by patients under the supervision of their physician) and consumer self-testing (i.e. testing carried out by the lay public on their own initiative).
This standard specifies requirements for the labelling of in-vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use. The term "self-testing" intends both patient self-testing (i.e. home-testing carried out by patients under the supervision of their physician) and consumer self-testing (i.e. testing carried out by the lay public on their own initiative).
EN 376:1992 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 376:1992 has the following relationships with other standards: It is inter standard links to EN 376:2002, ENV 13607:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 376:1992 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In-vitro-Diagnostik/Diagnostika - Kennzeichnung und Produktinformationen von In-vitro-Diagnostika für den Gebrauch durch LaienSystemes d'analyses médicales in vitro - Etiquetage des réactifs pour le diagnostic pour l'utilisation comme auto-testIn vitro diagnostic systems - Requirements for labelling in vitr
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