EN 62220-1-1:2015

Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging

IEC 62220-1-1:2015 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories. This first edition of IEC 62220-1-1 cancels and replaces IEC 62220-1:2003. It constitutes a technical revision of IEC 62220-1:2003 and assures a better alignment with the other parts of the IEC 62220 series. The main changes are as follows: - necessary modifications have been applied as a consequence of taking into account IEC 61267:2005. This influences HVL values and SNRin2; - the method for the determination of LAG EFFECTS now considers lag and ghosting compensation; - as part of the MTF determination, the method of obtaining the final averaged MTF has been restricted (only averaging of the ESF is allowed); - a description of (optionally) obtaining the diagonal (45°) MTF and NPS has been added.

Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-1: Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung

Appareils électromédicaux - Caractéristiques des dispositifs d’imagerie à rayonnements x - Partie 1-1: Détermination de l'efficacité quantique de détection - Détecteurs utilisés en imagerie radiographique

L'IEC 62220-1-1:2015 spécifie la méthode de détermination de l'EFFICACITE QUANTIQUE DE DETECTION (EQD) des DISPOSITIFS D'IMAGERIE NUMERIQUE A RAYONNEMENT X en tant qu'une fonction du KERMA DANS L'AIR et de la FREQUENCE SPATIALE pour les conditions de fonctionnement dans la gamme des applications médicales, telles que spécifiées par le FABRICANT. Les utilisateurs prévus de la présente partie de l'IEC 62220 sont les fabricants et les laboratoires d'essai bien équipés. La présente Partie 1-1 est limitée aux DISPOSITIFS D'IMAGERIE NUMERIQUE A RAYONNEMENT X qui sont utilisés dans l'imagerie radiographique, tels que, mais pas exclusivement, les systèmes CR et les systèmes à base de détecteur à panneau plat direct ou indirect. Cette première édition de l'IEC 62220-1-1 annule et remplace l'IEC 62220-1:2003. Cette édition constitue une révision technique de l'IEC 62220-1:2003 et assure un meilleur alignement avec les autres parties de la série IEC 62220. Les changements majeurs sont les suivants: - l'application des modifications nécessaires suite à la prise en compte de l'IEC 61267:2005. Cela influence les valeurs de HVL et SNRin2; - la prise en compte de la compensation de rémanence ou d'images fantômes dans la méthode pour la détermination des EFFETS DE REMANENCE; - la limitation de la méthode d'obtention de la MTF moyenne finale dans le cadre de la détermination de la MTF (seul l'établissement de la moyenne de l'ESF est autorisé); - l'ajout d une description de l'obtention (facultative) de la MTF diagonale (45 degrés) et du NPS.

Medicinska električna oprema - Karakteristike digitalnih naprav za rentgensko slikanje - 1-1. del: Ugotavljanje kvantnega izkoristka zaznavanja - Detektorji za rentgensko slikanje

Ta del standarda IEC 62220 določa metodo za ugotavljanje KVANTNEGA IZKORISTKA ZAZNAVANJA (DQE) DIGITALNIH NAPRAV ZA RENTGENSKO SLIKANJE kot funkcije KERME V ZRAKU in PROSTORSKE FREKVENCE za delovne pogoje v razponu medicinske uporabe, kot jo določi PROIZVAJALEC. Predvideni uporabniki tega dela standarda IEC 62220 so proizvajalci in dobro opremljeni preskusni laboratoriji.
OPOMBA 1: Čeprav to ni priporočljivo, uporaba tega standarda za ugotavljanje DQE digitalnih naprav za rentgensko slikanje, vgrajenih v klinični sistem, ni izključena, dokler se upoštevajo zahteve iz tega standarda.
Dodatno bi bili lahko pozorni na (na primer, vendar ne le na to) določitev zahtevanih LASTNOSTI SEVANJA, zmanjšanje vplivov razpršenega in odbitega razpršenega sevanja, točne meritve KERME V ZRAKU, določanje položaja PRESKUSNE NAPRAVE, prisotnost zaščitnih pokrovov, odstranitev PROTIRAZPRŠILNE MREŽICE. 1-1. del je omejen na DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, ki se uporabljajo za radiografsko slikanje, kot so (vendar ne izključno) sistemi za računalniško digitalno radiografijo (CR), neposredni in posredni sistemi na podlagi ploščatih detektorjev.
Tega dela standarda IEC 62220 ni priporočljivo uporabljati za digitalne sisteme na podlagi OJAČEVALCEV RENTGENSKE SLIKE.
OPOMBA 2: Uporaba tega standarda za sisteme na podlagi OJAČEVALCEV RENTGENSKE SLIKE ni priporočljiva zaradi nizkofrekvenčnega upada, vinjetiranja in geometrijskega popačenja, prisotnega v teh napravah, kar lahko zelo omeji uporabnost merilnih metod, opisanih v tem standardu.
Ta del standarda IEC 62220 se ne uporablja za:
– DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, namenjene uporabi v mamografiji ali dentalni radiografiji,
– DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, ki skenirajo reže,
– RAČUNALNIŠKO TOMOGRAFIJO,
– naprave za dinamično slikanje (pri čemer se pridobijo serije slik, kot pri fluoroskopiji ali slikanju srca).
OPOMBA 3: Navedene naprave so izključene, ker vključujejo veliko parametrov (na primer lastnosti žarka, geometrijo, časovno odvisnost itd.), ki se razlikujejo od parametrov, pomembnih za RADIOGRAFIJO. Nekatere od teh tehnik so opisane v drugih delih standardov IEC 62220 (IEC 62220-1-2 in IEC 62220-1-3).

General Information

• Status: Published
• Publication Date: 11-Jun-2015
• Withdrawal Date: 15-Apr-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 12-Jun-2015
• Completion Date: 12-Jun-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - 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 62220-1-1:2015 - Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging

Relations

• Replaces: EN 62220-1:2004 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62220-1-1:2015
01-september-2015
1DGRPHãþD
SIST EN 62220-1:2004
0HGLFLQVNDHOHNWULþQDRSUHPD.DUDNWHULVWLNHGLJLWDOQLKQDSUDY]DUHQWJHQVNR
VOLNDQMHGHO8JRWDYOMDQMHNYDQWQHJDL]NRULVWND]D]QDYDQMD'HWHNWRUML]D
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Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1:
Determination of the detective quantum efficiency - Detectors used in radiographic
imaging
Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-1:
Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung
Appareils électromédicaux - Caractéristiques des appareils d’imagerie à rayonnements x
- Partie 1-1: Détermination de l'efficacité quantique de détection - Détecteurs utilisés en
imagerie radiographique
Ta slovenski standard je istoveten z: EN 62220-1-1:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 62220-1-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62220-1-1:2015

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SIST EN 62220-1-1:2015


EUROPEAN STANDARD EN 62220-1-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.50 Supersedes EN 62220-1:2004
English Version
Medical electrical equipment - Characteristics of digital x-ray
imaging devices - Part 1-1: Determination of the detective
quantum efficiency - Detectors used in radiographic imaging
(IEC 62220-1-1:2015)
Appareils électromédicaux - Caractéristiques des appareils Medizinische elektrische Geräte - Merkmale digitaler
d'imagerie à rayonnements x - Partie 1-1: Détermination de Röntgenbildgeräte - Teil 1-1: Bestimmung der detektiven
l'efficacité quantique de détection - Détecteurs utilisés en Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung
imagerie radiographique (IEC 62220-1-1:2015)
(IEC 62220-1-1:2015)
This European Standard was approved by CENELEC on 2015-04-16. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.



European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 62220-1-1:2015 E

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SIST EN 62220-1-1:2015
EN 62220-1-1:2015
Foreword
The text of document 62B/968/FDIS, future edition 2 of IEC 62220-1-1, prepared by SC 62B, "Diagnostic
imaging equipment", of IEC TC 62, "Electrical equipment in medical practice " was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN 62220-1-1:2015.
The following dates are fixed:
(dop) 2016-01-16
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-16
standards conflicting with the
document have to be withdrawn

This document supersedes EN 62220-1:2004.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 62220-1-1:2015 was approved by CENELEC as a European
Standard without any modificatio
...