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SIST EN 60601-2-1:2002

(Main)

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)

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)

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 (IEC 60601-2-1:1998)

Appareils électromédicaux - Partie 2-1: Règles particulières de sécurité pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV (CEI 60601-2-1:1998)

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Withdrawn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
31-Jan-2002
Withdrawal Date
17-Sep-2018
ICS
11.040.50 - Radiographic equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
18-Sep-2018
Due Date
11-Oct-2018
Completion Date
18-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
Ref Project
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

Relations

Replaced By
SIST EN 60601-2-1:2015 - Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Effective Date
28-Jan-2023
Replaced By
SIST EN 60601-2-1:2015 - Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Effective Date
01-Dec-2015
Amended By
SIST EN 60601-2-1:2002/A1:2003 - 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
Amended By
SIST EN 60601-2-1:2002/A1:2003 - 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
07-Jun-2022
Replaced By
SIST EN 60601-2-1:2015 - Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Effective Date
07-Jun-2022
Amended By
SIST EN 60601-2-1:2002/A1:2003 - 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
01-Mar-2003

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-1:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
HOHNWURQVNHSRVSHãHYDOQLNHYREPRþMXRG0H9GR0H9 ,(&
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
...

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