SIST EN 60601-2-43:2002

Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures (IEC 60601-2-43:2000)

Establishes safety requirements for the design and manufacture of X-ray equipment for prolonged radioscopically guided interventional procedures. Specifies information which is to be provided with such equipment for the assistance of the user and operator in managing the radiation risk arising from these procedures which could affect patients and staff.

Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2000)

Appareils électromédicaux - Partie 2-43: Règles particulières de sécurité pour les appareils radiologiques lors d'interventions (CEI 60601-2-43:2000)

Medicinska električna oprema - 2-43. del: Posebne varnostne zahteve za rentgensko opremo za intervencijske postopke (IEC 60601-2-43:2000)

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2002
• Withdrawal Date: 19-Apr-2016
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 19-Apr-2016
• Due Date: 12-May-2016
• Completion Date: 20-Apr-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-43:2000 - Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

Relations

• Replaced By: SIST EN 60601-2-43:2010 - Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-43:2002
01-februar-2002
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Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray
equipment for interventional procedures (IEC 60601-2-43:2000)
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit
von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2
...