BS EN IEC 63077:2019 - Good refurbishment practices for medical imaging equipment

BS EN IEC 63077:2019

Good refurbishment practices for medical imaging equipment

Status : Current   Published : January 2020

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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.




Standard NumberBS EN IEC 63077:2019
TitleGood refurbishment practices for medical imaging equipment
StatusCurrent
Publication Date03 January 2020
Normative References(Required to achieve compliance to this standard)ISO 13485, EN ISO 13485:2016, ISO 13485:2016, ISO 14971:2007, EN ISO 13485:2016/AC:2018
Informative References(Provided for Information)IEC 61223-2-6:2006, IEC TR 60788:2004, IEC 61675-2:2015, IEC 60601-1:2005, IEC 62353:2014, IEC 60601-2-37:2007, IEC 60601-1:2005/AMD1:2012, EN 60601-1:2006, IEC 60601-1-3:2008, IEC 60601-2-43:2010, EN 62353:2014, IEC 60601-2-33:2010, IEC TR 61948-3:2018
ReplacesPD IEC/PAS 63077:2016
International RelationshipsEN IEC 63077:2019,IEC 63077:2019
Draft Superseded By18/30372779 DC
DescriptorsMedical instruments, Safety measures, Management, Risk analysis, Clinical investigation instruments, Risk assessment, Hazards, Medical equipment, Diagnosis (medical)
ICS11.040.55
Title in FrenchBonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
Title in GermanSachgemäße Verfahren zur Aufarbeitung von medizinischen bildgebenden Geräten
CommitteeCH/62/2
ISBN978 0 580 99848 5
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size773 KB
Price£130.00


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