EN 540:1993

Clinical investigation of medical devices for human subjects

This European Standard pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market.   This European Standard does not apply to in vitro diagnostic devices.

Klinische Prüfung von medizinischen Geräten für Versuchspersonen

Diese europäische Norm gilt für die klinische Prüfung mit Versuchspersonen solcher Medizinprodukte, deren klinische Leistungsfähigkeit vor der Markteinführung einer Beurteilung bedarf. Diese europäische Norm gilt nicht für Medizinprodukte für die In-vitro-Diagnose.

Investigation clinique des dispositifs médicaux sur les sujets humains

La présente norme européenne traite de l'investigation clinique sur les sujets humains des matériels médicaux dont les performances cliniques doivent être évaluées avant la commercialisation. La présente norme européenne ne s'applique pas aux dispositifs de diagnostic in vitro.

Klinične raziskave medicinskih pripomočkov za ljudi

General Information

• Status: Withdrawn
• Publication Date: 27-Jun-1993
• Withdrawal Date: 14-Feb-2003
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.060.01 - Dentistry in general
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 258 - Clinical investigation of medical devices
• Drafting Committee: CEN/TC 258 - Clinical investigation of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Feb-2003
• Completion Date: 15-Feb-2003
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 540:2000 - Clinical investigation of medical devices for human subjects

Relations

• Replaced By: EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Klinische Prüfung von medizinischen Geräten für VersuchspersonenInvestigation clinique des dispositifs médicaux sur les sujets humainsClinical investigation of medical devices for human subjects11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 540:1993SIST EN 540:2
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