IEC 63077:2019
(Main)Good refurbishment practices for medical imaging equipment
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.
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.
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Standards Content (Sample)
IEC 63077 ®
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Good refurbishment practices for medical imaging equipment
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
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IEC 63077 ®
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Good refurbishment practices for medical imaging equipment
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-7595-5
– 2 – IEC 63077:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT . 9
4.1 Quality management system . 9
4.2 Resource management . 9
4.3 Corrective and preventive action . 9
4.4 Customer complaints . 9
4.5 Production and service provision . 9
4.6 Control of nonconforming PRODUCT . 10
4.7 Post-market surveillance PROCESS . 10
4.8 Document control . 10
4.9 Purchasing . 10
4.10 Control of design and design changes . 10
4.11 RISK management PROCESS . 10
5 Specific requirements for good REFURBISHMENT practice . 11
5.1 General . 11
5.2 Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT . 11
5.3 Evaluating market access requirements . 11
5.4 Preparation for REFURBISHMENT, disassembly, packing, and transport . 11
5.5 Planning . 11
5.6 Installation of software and hardware to ensure the safety of the MEDICAL
IMAGING EQUIPMENT . 12
5.7 Performance and safety test . 12
5.8 Packing, transport, and installation of refurbished MEDICAL IMAGING
EQUIPMENT. 12
5.9 Record of REFURBISHMENT . 12
5.10 REFURBISHMENT label . 12
Annex A (informative) Cross reference list of the contents of IEC 63077 versus
ISO 13485 . 13
Bibliography . 15
Index of defined terms used in this document . 16
Table A.1 – Cross reference list of the contents of IEC 63077 versus ISO 13485 . 13
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
FOREWORD
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International Standard IEC 63077 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This first edition cancels and replaces the second edition of IEC PAS 63077 published in 2016.
This edition constitutes a technical revision.
This edition 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.
– 4 – IEC 63077:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
62B/1149/FDIS 62B/1155/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3: SMALL CAPITALS.
The committee has decided that the contents of this document will rem
...
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