EN 540:1993
(Main)Clinical investigation of medical devices for human subjects
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- Withdrawn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
- 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
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 10-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 540:1993 is a standard published by the European Committee for Standardization (CEN). Its full title is "Clinical investigation of medical devices for human subjects". This standard covers: 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.
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.
EN 540:1993 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.060.01 - Dentistry in general; 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 540:1993 has the following relationships with other standards: It is inter standard links to EN ISO 14155-1:2003, EN 45502-1:1997, EN 4840-101:2018, EN 4840-001:2018, EN 4840-102:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 540:1993 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. 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 540:1993 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.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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