PD IEC/PAS 63077:2016 - Good refurbishment practices for medical imaging equipment
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PD IEC/PAS 63077:2016

Good refurbishment practices for medical imaging equipment

Status : Withdrawn   Published : November 2016 Replaced By : BS EN IEC 63077:2019

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IEC PAS 63077:2016(E) 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 effectiveness comparable to that of new equipment. 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 must be performed and the manner consistent with product 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.




Standard NumberPD IEC/PAS 63077:2016
TitleGood refurbishment practices for medical imaging equipment
StatusWithdrawn
Publication Date30 November 2016
Withdrawn Date03 January 2020
Normative References(Required to achieve compliance to this standard)ISO 13485:2016, ISO 14971:2007
Informative References(Provided for Information)IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005, IEC 62353:2014, US FDA 21 CFR Part 820
Replaced ByBS EN IEC 63077:2019
International RelationshipsIEC PAS 63077:2016
DescriptorsMedical instruments, Medical equipment, Diagnosis (medical), Risk analysis, Risk assessment, Management, Hazards, Clinical investigation instruments, Safety measures
ICS11.040.55
CommitteeCH/62/2
ISBN978 0 580 95743 7
PublisherBSI
FormatA4
DeliveryYes
Pages16
File Size1.81 MB
Price£130.00


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*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
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