Good refurbishment practices for medical imaging equipment

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: – X-RAY EQUIPMENT; – X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; – X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; – MAGNETIC RESONANCE EQUIPMENT; – ULTRASONIC DIAGNOSTIC EQUIPMENT; – GAMMA CAMERAS; – PLANAR WHOLEBODY IMAGING EQUIPMENT; – equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); – SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – POSITRON EMISSION TOMOGRAPHS (PET); – PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and – other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems. IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016: a) the scope was delineated more clearly; b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added; c) smaller corrections were performed.

Sachgemäße Verfahren zur Aufarbeitung von medizinischen bildgebenden Geräten

Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale

L'IEC 63077:2019 décrit et définit le PROCESSUS de RECONDITIONNEMENT des APPAREILS D’IMAGERIE MEDICALE USAGES et s’applique à redonner aux APPAREILS D’IMAGERIE MEDICALE USAGES une condition de sécurité et de performances comparable à celle d’un appareil neuf, c’est-à-dire un APPAREIL D’IMAGERIE MEDICALE qui n’a pas été utilisé. Cette restauration inclut des actions telles que la REPARATION, la RETOUCHE, les mises à jour logiciel/matériel ainsi que le remplacement des pièces usagées par des pièces d’origine. Le présent document énumère les actions qui sont réalisées en cohérence avec les spécifications et les procédures d’entretien applicables, exigées pour garantir que le RECONDITIONNEMENT d’un APPAREIL D’IMAGERIE MEDICALE est effectué sans modification des performances de l’APPAREIL D’IMAGERIE MÉDICALE fini, des spécifications de sécurité ni de l’UTILISATION PREVUE selon son enregistrement valide d’origine ou applicable. Les APPAREILS et systèmes D’IMAGERIE MEDICALE couverts par le présent document incluent les éléments suivants: – APPAREILS À RAYONNEMENT X; – APPAREILS A RAYONNEMENT X pour INTERVENTIONS GUIDEES PAR RADIOSCOPIE; – APPAREILS A RAYONNEMENT X POUR TOMODENSITOMETRIE; – APPAREILS À RÉSONANCE MAGNÉTIQUE; – APPAREILS DE DIAGNOSTIC A ULTRASONS; – CAMÉRAS GAMMA; – EQUIPEMENTS D’IMAGERIE PLANAIRE DU CORPS ENTIER; – appareils pour TOMODENSITOMETRIE PAR EMISSION DE PHOTONS SIMPLES (SPECT); – systèmes hybrides SPECT/CT, combinant une CAMERA GAMMA et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – TOMOGRAPHES A EMISSION DE POSITRONS (PET); – systèmes hybrides SPECT/CT combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – systèmes hybrides PET/MRI combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un APPAREIL A RESONANCE MAGNETIQUE: et – autres combinaisons des APPAREILS ou systèmes énumérés ci-dessus. Le présent document ne s’applique pas aux appareils d’endoscopie, aux appareils pour fond d’œil, aux appareils de radiothérapie ni aux systèmes associés. L'IEC 63077:2019 inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) le domaine d'application a été défini plus précisément; b) une liste informative des références croisées du contenu de l'IEC 63077 en regard de l'ISO 13485 a été ajoutée (Annexe A); c) de petites corrections ont été faites.

Dobre prakse za obnovo medicinske opreme za slikanje (IEC 63077:2019)

Ta dokument opisuje in opredeljuje PROCES OBNOVE UPORABLJENE MEDICINSKE OPREME ZA SLIKANJE in se navezuje na obnovo UPORABLJENE MEDICINSKE OPREME ZA SLIKANJE do stanja varnosti in učinkovitosti, ki je primerljivo z novo MEDICINSKO OPREMO ZA SLIKANJE, tj. MEDICINSKO OPREMO ZA SLIKANJE, ki še ni bila uporabljena. Ta obnova vključuje ukrepe, kot so POPRAVILO, PREDELAVA, posodobitve programske/strojne opreme in zamenjava dotrajanih delov z originalnimi deli. Ta dokument našteva izvedene ukrepe in način, skladen z ustreznimi specifikacijami in servisnimi postopki, potrebnimi za zagotovitev, da se OBNOVA MEDICINSKE OPREME ZA SLIKANJE izvede brez spreminjanja zmogljivosti, varnostnih specifikacij ali NAMENA UPORABE končne MEDICINSKE OPREME ZA SLIKANJE v skladu z zahtevami izvirne ali trenutno veljavne registracije. MEDICINSKA OPREMA ZA SLIKANJE in sistemi, ki jih zajema ta dokument, so: – RENTGENSKA OPREMA; – RENTGENSKA OPREMA za RADIOSKOPSKO VODENE INTERVENCIJSKE POSTOPKE; – RENTGENSKA OPREMA ZA RAČUNALNIŠKO TOMOGRAFIJO; – MAGNETNO RESONANČNA OPREMA; – ULTRAZVOČNA DIAGNOSTIČNA OPREMA; – GAMA KAMERE; – OPREMA ZA PLANARNO SLIKANJE CELOTNEGA TELESA; – oprema za RAČUNALNIŠKO TOMOGRAFIJO Z ENIM FOTONOM (SPECT); – hibridni sistemi SPECT/CT, ki združujejo GAMA KAMERO z RENTGENSKO OPREMO ZA RAČUNALNIŠKO TOMOGRAFIJO (CT); – POZITRONSKA EMISIJSKA TOMOGRAFIJA (PET); – hibridni sistemi PET/CT, ki združujejo POZITRONSKO EMISIJSKO TOMOGRAFIJO z RENTGENSKO OPREMO ZA RAČUNALNIŠKO TOMOGRAFIJO (CT); – hibridni sistemi PET/MRI, ki združujejo POZITRONSKO EMISIJSKO TOMOGRAFIJO in OPREMO ZA MAGNETNO RESONANCO; in – druge kombinacije zgoraj navedene MEDICINSKE OPREME ZA SLIKANJE ali sistemov. Ta dokument se ne uporablja za endoskopsko opremo, funduskopsko opremo, opremo za sevalno terapijo ter povezane sisteme

General Information

Status
Published
Publication Date
19-Dec-2019
Current Stage
6060 - Document made available - Publishing
Start Date
20-Dec-2019
Completion Date
20-Dec-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 63077:2020
01-marec-2020
Dobre prakse za obnovo medicinske opreme za slikanje (IEC 63077:2019)
Good refurbishment practices for medical imaging equipment (IEC 63077:2019)
Sachgemäße Verfahren zur Aufarbeitung von medizinischen bildgebenden Geräten (IEC
63077:2019)
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale (IEC
63077:2019)
Ta slovenski standard je istoveten z: EN IEC 63077:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 63077:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 63077:2020

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SIST EN IEC 63077:2020


EUROPEAN STANDARD EN IEC 63077

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2019
ICS 11.040.55

English Version
Good refurbishment practices for medical imaging equipment
(IEC 63077:2019)
Bonnes pratiques de reconditionnement pour les appareils Sachgemäße Verfahren zur Aufarbeitung von
d'imagerie médicale medizinischen bildgebenden Geräten
(IEC 63077:2019) (IEC 63077:2019)
This European Standard was approved by CENELEC on 2019-12-18. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 63077:2019 E

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SIST EN IEC 63077:2020
EN IEC 63077:2019 (E)
European foreword
The text of document 62B/1149/FDIS, future edition 1 of IEC 63077, 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 IEC 63077:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-09-18
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-12-18
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 63077:2019 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified)
IEC 62353:2014 NOTE Harmonized as EN 62353:2014 (not modified)

2

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SIST EN IEC 63077:2020
EN IEC 63077:2019 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
ISO 13485 -  Medical devices -- Quality management EN ISO 13485 2016
systems -- Re
...

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