EN 60601-2-1:1998

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

Establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy and defines type tests and site tests. Places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the equipment.

Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit von Elektronenbeschleunigern im Bereich von 1 MeV bis 50 MeV

Appareils électromédicaux - Partie 2-1: Règles particulières de sécurité pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV

Etablit les prescriptions auxquelles il convient que les constructeurs se conforment dans la conception et la construction des accélérateurs d'électrons utilisés en radiothérapie et décrit des essais de type et des essais sur le site. Fixe des limites de détérioration des performances des appareils qui seraient la conséquence d'une condition de défaut pour lesquelles un verrouillage entre en action pour empêcher l'appareil de continuer à fonctionner.

Medicinska električna oprema - 2-1. del: Posebne varnostne zahteve za elektronske pospeševalnike v območju od 1 MeV do 50 MeV (IEC 60601-2-1:1998)

General Information

• Status: Withdrawn
• Publication Date: 13-Aug-1998
• Withdrawal Date: 30-Apr-2001
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2018
• Completion Date: 15-Sep-2018
• 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 60601-2-1:2002 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)

Relations

• Replaced By: EN 60601-2-1:2015 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-1:1998/A1:2002 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2002
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Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron
accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit
von Elektronenbeschleunigern im Bereich von 1 Me
...