EN 60601-2-28:1993

Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

Specifies the safety requirements for X-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical X-ray equipment including equipment for computed tomography, that incorporates a specified high-voltage generator complying with HD 395.2.7 or HD 395.2.15.

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Röntgenstrahler einschließlich Blendensystem für medizinische Diagnostik

Appareils éléctromédicaux - Partie 2: Règles particulières de sécurité pour les ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical

Spécifie les prescriptions de sécurité pour les ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical et aux composants de ceux-ci, spécifiés pour utilisations dans un équipement à rayonnement X, y compris les équipements pour tomodensitométrie, qui comprennent un générateur radiologique spécifié en conformité avec HD 395.2.7 ou la HD 395.2.15

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za vire rentgenskih žarkov in sklope rentgenskih cevi za medicinsko diagnostiko (IEC 60601-2-28:1993)

General Information

• Status: Withdrawn
• Publication Date: 27-May-1993
• Withdrawal Date: 28-Feb-1994
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2013
• Completion Date: 01-Apr-2013
• 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
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-28:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

Relations

• Replaced By: EN 60601-2-28:2010 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• Effective Date: 28-Jan-2023
• Replaced By: EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-1995
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UHQWJHQVNLKåDUNRYLQVNORSHUHQWJHQVNLKFHYL]DPHGLFLQVNRGLDJQRVWLNR,(&

Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray
source assemblies and X-ray tube assemblies for medical diagnosis
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Röntgenstrahler einschließlich Blendensystem für medizinische Diagnostik
Appareils éléctromédicaux - Partie 2: Règles particulières de sécurité pour les
ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical
Ta slovenski standard je istoveten z: EN 60601-2-28:1993
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST
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