IEC PAS 63077 Edition 1 0 201 6 1 1 PUBLICLY AVAILABLE SPECIFICATION PRE STANDARD Good refurbishment practices for medical imaging equipment IE C P A S 6 3 0 7 7 2 0 1 6 1 1 (e n ) ® International Ele[.]
I E C P AS 63 7 ® P U B LI C LY AVAI LAB LE S P E C I F I C ATI ON P RE -S TAN D ARD IEC PAS 63077:201 6-1 (en) G ood refu rbi s h m e n t practi ces for m e d i cal i m ag i n g eq u i pm en t I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n Edition 201 6-1 T H I S P U B L I C AT I O N I S C O P YRI G H T P RO T E C T E D C o p yri g h t © I E C , G e n e v a , S wi tz e rl a n d All rights reserved Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester If you have any questions about I EC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local I EC member National Committee for further information IEC Central Office 3, rue de Varembé CH-1 21 Geneva 20 Switzerland Tel.: +41 22 91 02 1 Fax: +41 22 91 03 00 info@iec.ch www.iec.ch Ab ou t th e I E C The I nternational Electrotechnical Commission (I EC) is the leading global organization that prepares and publishes I nternational Standards for all electrical, electronic and related technologies Ab o u t I E C p u b l i ca ti o n s The technical content of IEC publications is kept under constant review by the IEC Please make sure that you have the latest edition, a corrigenda or an amendment might have been published I E C Catal og u e - webstore i ec ch /catal og u e The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents Available for PC, Mac OS, Android Tablets and iPad I E C pu bl i cati on s s earch - www i ec ch /search pu b The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,…) It also gives information on projects, replaced and withdrawn publications E l ectroped i a - www el ectroped i a org The world's leading online dictionary of electronic and electrical terms containing 20 000 terms and definitions in English and French, with equivalent terms in additional languages Also known as the International Electrotechnical Vocabulary (IEV) online I E C G l os sary - s td i ec ch /g l oss ary 65 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002 Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR I E C J u st Pu bl i s h ed - webstore i ec ch /j u stpu bl i sh ed Stay up to date on all new IEC publications Just Published details all new publications released Available online and also once a month by email I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I E C C u stom er S ervi ce C en tre - webstore i ec ch /csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch I E C P AS 63 7 ® Edition 201 6-1 P U B LI C LY AVAI LAB LE S P E C I F I C ATI ON P RE -S TAN D ARD G ood refu rbi s h m en t practi ces for m ed i cal i m ag i n g eq u i pm en t INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 1 040.55 ISBN 978-2-8322-3761 -8 Warn i n g ! M ake s u re th a t you ob tai n ed th i s p u b l i cati on from an au th ori zed d i stri b u tor ® Registered trademark of the International Electrotechnical Commission I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n –2– I EC PAS 63077:201 © I EC 201 CONTENTS FOREWORD I NTRODUCTI ON Scope Norm ative references Terms and definitions General requirem ents for refurbishm ent of used m edical devices Quality managem ent system Resource managem ent Corrective and preventive action 4 Custom er com plaints Production and service provision Control of non-conform ing product Post-m arket surveillance process Document control 9 Purchasing Control of design and design changes 1 Risk management process Specific requirem ents for good refurbishment practice General Selection of medical im aging equipment for refurbishm ent Evaluating m arket access requirem ents Preparation for refurbishm ent, disassembly, packing, and shipment 5 Planning 1 I nstallation of safety updates (hardware/software) 1 Perform ance and safety test 1 Packing, shipm ent, and installation of refurbished m edical im aging equipment 1 Record of refurbishm ent 1 Refurbishment label 1 Bibliograph y I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I EC PAS 63077:201 © I EC 201 –3– INTERNATI ONAL ELECTROTECHNI CAL COMMISSI ON G O O D RE F U RB I S H M E N T P R AC T I C E S F O R M E D I C AL I M AG I N G E Q U I P M E N T FOREWORD ) The I nternati on al Electrotechni cal Comm ission (I EC) is a worl d wid e organization for stan dardization com prisin g all n ation al el ectrotechnical comm ittees (I EC National Comm ittees) The object of I EC is to prom ote internati onal co-operation on all q uestions concerni ng stand ardi zati on in the el ectrical an d electronic fi elds To this en d and in additi on to other acti vities, I EC pu blish es I nternational Stan dards, Techn ical Specificati ons, Technical Reports, Publicl y Avail abl e Specificati ons (PAS) an d Gu ides (h ereafter referred to as “I EC Publication(s)”) Th ei r preparation is entrusted to tech nical comm ittees; any I EC N ational Comm ittee interested in the subj ect dealt with m ay partici pate in this preparatory work I nternational, governm ental an d n on governm ental organ izations l iaising with th e I EC also participate i n this preparation I EC collaborates closel y with the I ntern ational Organi zation for Stand ardization (I SO) in accordance with ditions determ ined by agreem ent between th e two organi zati ons 2) The form al decisions or ag reem ents of I EC on tech nical m atters express, as n early as possible, an i nternati onal consensus of opi nion on the rel evant subjects since each technical com m ittee has representati on from all interested I EC N ational Com m ittees 3) I EC Publications have the form of recom m endations for intern ational use an d are accepted by I EC National Com m ittees in that sense While all reasonable efforts are m ade to ensure that 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servants or ag ents inclu din g in divi dual experts an d m em bers of its technical com m ittees and I EC Nati on al Com m ittees for any person al i njury, property d am age or other dam age of any nature whatsoever, wheth er di rect or indirect, or for costs (includ i ng leg al fees) and expenses arisi ng out of the publ ication, use of, or relian ce upon, this I EC Publicati on or any other I EC Publications 8) Attention is drawn to th e N orm ative references cited in th is publ ication Use of the referenced publ ications is indispensable for the correct applicati on of this publication 9) Attention is drawn to the possibility that som e of the elem ents of this I EC Publication m ay be the su bject of patent rig hts I EC shall not be held responsibl e for identifyi ng any or all such patent ri ghts A PAS is a technical specification not fulfilling the requirem ents for a standard, but m ade available to the public I EC PAS 63077 has been processed by subcomm ittee 62B: Diagnostic im aging equipment, of I EC technical committee 62: Electrical equipment in medical practice The text of this PAS is based on the following docum ent: D ft P AS 62B/1 022/PAS This PAS was approved for publ ication by th e P-m em bers of the comm ittee concerned as ind icated in the foll owi ng d ocum ent R e p o rt o n vo ti n g 62B/1 030/RVC Following publication of this PAS, which is a pre-standard publication, the technical comm ittee or subcom mittee concerned may transform it into an I nternational Standard I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n –4– I EC PAS 63077:201 © I EC 201 This PAS shall remain valid for an initial m axim um period of years starting from the publication date The validity m ay be extended for a single period up to a maxim um of years, at the end of which it shall be published as another type of normative docum ent, or shall be withdrawn I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I EC PAS 63077:201 © I EC 201 –5– INTRODUCTION Keeping up with the latest innovations in medical technology often involves replacing equipm ent in m edical practice before it reaches the end of its expected service life This is because innovation cycles for medical technology are m uch shorter than the functional lifecycle of capital equipm ent As a result, a sustainable resource management model is required: earl y replacement of installed medical im aging equipm ent by newer technolog y is more econom icall y feasible if the residual value of the existing m edical imaging equipment is utilized Conserving assets is a fundam ental principle of ecological thinking in a recycling econom y Several m edical imaging equipm ent companies have alread y set up quality m anagement systems to refurbish used m edical im aging equipment and have delivered this refurbished equipm ent across the healthcare sector for m any years Refurbishm ent addresses the high demand for affordable and reliable products Customers of this used equipm ent are not only sm all hospitals with limited budgets but also leading medical institutes The EU and the US represent by far the two largest m arkets for refurbished m edical equipm ent Refurbishment of used m edical im aging equipment is a well-established elem ent of the healthcare econom y I f used medical imaging equipment is not accuratel y m aintained according to requirem ents defined by the manufacturer, it m ay result in additional risk for patients and operators Consequentl y, som e countries have imposed bans on the importation of used m edical im aging equipm ent to protect public health These bans fail to distinguish between quality-assured refurbished medical imaging equipm ent and second-hand medical imaging equipm ent of undefined quality, with the effect that patients m ay be denied access to the safe and econom ical medical im aging equipment they need Safety and effectiveness are the m ost im portant aspects to consider with m edical im aging equipm ent, including used equipment To ensure safety and effectiveness, used medical im aging equipment has to be refurbished in a highl y specialized and quality-assured way I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n –6– I EC PAS 63077:201 © I EC 201 G O O D RE F U RB I S H M E N T P R AC T I C E S F O R M E D I C AL I M AG I N G E Q U I P M E N T S cop e This document describes and defines the process of refurbishment of used m edical im aging equipm ent and applies to the restoring of used medical im aging equipm ent to a condition of safety and effectiveness com parable 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 enum erates the actions that m ust be perform ed and the manner consistent with product specifications and service procedures required to ensure that the refurbishm ent of medical imaging equipment is done without changing the finished medical im aging equipment’s performance, safety specifications, or intended use according to its original or applicable valid registration N o rm a t i ve re fe re n c e s The following docum ents are referred to in the text in such a way that som e or all of their content constitutes requirements of this docum ent For dated references, onl y the edition cited applies For undated references, the latest edition of the referenced docum ent (including an y am endm ents) applies I SO 3485: 201 6, Medical devices – Quality management systems – Requirements for regulatory purposes ISO 4971 : 2007, Medical devices – Application of risk management to medical devices T e rm s a n d d e fi n i t i o n s For the purposes of this docum ent, the following terms and definitions apply I SO and I EC maintain term inological databases for use in standardization at the following addresses: • • I EC Electropedia: available at http://www electropedia org/ I SO Online browsing platform : available at http: //www iso org/obp exp e cted s e rv i c e l i fe time period specified by the manufacturer during which the medical electrical equipment or medical electrical system is expected to remain safe for use (i e maintain basic safety and essential perform ance) Note to entry: Maintenance can be n ecessary d uri ng th e expected service life [SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 28] i n te n d e d use i n te n d e d p u rp o s e use for which a product, process, or service is intended according to the specifications, instructions and inform ation provided by the manufacturer I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I EC PAS 63077:201 © I EC 201 –7– Note to entry: I ntend ed use shoul d n ot be confused with norm al use While both inclu d e the concept of use as inten ded by th e m anufactu rer, inten ded use focuses on the m edical pu rpose while norm al use incorporates not onl y the m edical pu rpose, but m aintenance, transport, etc as well [SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 44] 3 man u factu rer natural or legal person with responsibility for the design, m anufacture, packaging, labelling, assembling, or adapting medical im aging equipm ent, regardless of whether these operations are perform ed by that person or on that person's behalf by a third party Note to entry: I SO 3485: 201 defin es “labell ing ” as “written, printed or graphic m atter as: a) affi xed to a m edical d evice or any of its contain ers or wrappers, or b) accom panyin g a m edical d evice, rel ated to i dentification, techni cal descripti on, and use of the m edical device, but exclu din g shippi ng d ocum ents I n this docum ent, that m aterial is described as m arkings and accom panyi ng d ocum ent Note to entry: Ad apti ng incl udes m aking substanti al m odifi cations to m edical im aging equ ipm ent alread y in use Note to entry: I n som e jurisdictions, the responsible refurbisher can be consi dered a m anufacturer when involved i n the acti vities d escri bed Note to entry: Ad apted from I SO 4971 : 2007, [SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 55, modified – The definition and Note have been reworded ] med i cal im ag in g eq u ipmen t medical electrical equipment that provides images for clinical applications Note to entry: See I EC 60601 -1 : 2005/AMD1 : 201 2, 63 for a defi nition of m edical el ectri cal equi pm ent n ormal u se operation, including routine inspection and adj ustments by an y operator, and stand-by, according to the instructions for use Note to entry: N orm al use should not be confused with i ntend ed use While both incl ud e the concept of use as inten ded by th e m anufactu rer, inten ded use focuses on the m edical pu rpose while norm al use incorporates not onl y the m edical pu rpose, but m aintenance, transport, etc as well [SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 71 ] operator person handling the medical imaging equipm ent [SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3.73, modified – The definition has been reworded ] refu rbi sh er natural or legal person who conducts refurbishm ent of m edical im aging equipm ent pati en t living being (person or anim al) undergoing a m edical, surgical or dental procedure Note to entry: A patient can be an operator I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n –8– I EC PAS 63077:201 © I EC 201 [SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 76] process set of inter-related or interacting activities which transform s inputs into outputs [SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 89] refu rbi sh m en t process or combination of processes applied during the expected service life to restore used medical im aging equipm ent to a condition of safety and effectiveness com parable to when new Note to entry: Refu rbishm ent can inclu de activities such as repair, rework, repl acem ent of worn parts, and update of software/hard ware but shall n ot includ e acti vities th at result i n regul atory su bm issions 1 repai r means for restoring to a safe, functional, normal condition [SOU RCE: I EC 62353: 201 4, 3.39] rework action taken on a nonconform ing product so that it will fulfill the specified Device Master Record requirem ents before it is released for distribution [SOU RCE: 21 CFR 820, (x)] 3 ri sk combination of the probability of occurrence of harm and the severity of that harm [SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 02] u sed m ed i cal im ag in g equ ipm en t medical imaging equipm ent that has been put into service 4 General req ui rem ents for refurbi shm ent of used m edi cal devi ces Qu al ity m an ag em en t system Refurbishm ent of used m edical imaging equipment shall be conducted under a quality managem ent system (QMS) of the refurbisher in compliance with I SO 3485: 201 I n addition to I SO 3485:201 6, the provisions in paragraphs 4.2 to 1 shall be applied Resou rce m an ag em en t The refurbisher shall determ ine, and provide adequate resources, including trained and qualified personal, m aintained and calibrated equipment, and instructions, procedures, files, records, or docum ents to perform the refurbishment, as well as an environment for refurbishm ent that is in com plete compliance with the applicable environmental, occupational health and safety, and pest control requirem ents I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I EC PAS 63077:201 © I EC 201 4.3 –9– Corrective and preventive action The refurbisher shall implement a com prehensive corrective action and preventive action (CAPA) process, addressing the specific aspects of the refurbishm ent of used medical im aging equipment In addition, in the event that the refurbisher identifies, through its CAPA system , safetyrelated issues that are the responsibility of the original manufacturer and not related to the refurbishm ent, it shall inform the original m anufacturer accordingl y 4.4 Customer complaints The refurbisher shall have in place a system for m anaging com plaints In addition, the refurbisher shall communicate to the original manufacturer all custom er complaints that are not related to the refurbishment of the equipm ent 4.5 Production and service provision The refurbisher shall have documented procedures for refurbishm ent and service including but not lim ited to process validation, disinfection processes, identification, traceability and packaging I n addition the organization shall m ake provisions to have the knowledge and the ability for installing and servicing medical imaging equipm ent, or to ensure that servicing can be m ade available in those m arkets where the refurbisher m akes refurbished medical im aging equipment available on the m arket 4.6 Control of non-conforming product The refurbisher shall ensure that a product that does not conform to product requirements is identified during refurbishm ent and controlled to prevent its unintended use or delivery When a non-conform ing product is corrected during refurbishm ent, it shall be subj ect to reverification to dem onstrate conformity to the requirem ents of the original m anufacturer 4.7 Post-market surveillance process The refurbisher shall collect feedback from custom ers and establish docum ented procedures to notify regulatory authorities of adverse events The process shall also determine if the adverse event is related to the refurbishm ent of the used medical im aging equipment or needs to be reported to the original m anufacturer The refurbisher shall also establish his or her own post-m arket surveillance process to monitor whether the additional risks resulting from refurbishment have been adequatel y mitigated The refurbisher shall enable monitoring of its installed base of refurbished m edical imaging equipment to allow for update managem ent for safety and effectiveness 4.8 Document control The refurbisher shall control all work instructions and procedures used to refurbish medical im aging equipment 4.9 Purchasing The refurbisher shall establish dedicated supplier m anagement capabilities when com ponents or services are purchased I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n – 10 – I EC PAS 63077:201 © I EC 201 4.1 Control of design and design changes The refurbisher shall review, verify, and validate potential design changes to ensure that the safety and effectiveness requirements of the equipment are not changed from its original or applicable valid registration All changes, including parts, shall be evaluated to determine if the refurbisher needs registration, as he or she m ay becom e the legal m anufacturer 4.1 Risk management process The refurbisher shall also establish a risk m anagem ent process that includes an y risk introduced by the refurbishment of used medical imaging equipm ent This includes changes that would affect parts 5.1 Specific requirements for good refurbishment practice General The refurbisher shall establish a specific process for the refurbishm ent of used medical imaging equipm ent that, in addition to the general requirem ents described in Clause includes the following specific requirem ents 5.2 Selection of medical imaging equipment for refurbishment The refurbisher shall determ ine the criteria that used medical im aging equipment need to meet in order to qualify for refurbishment, based on an assessment of the risk (in accordance with I SO 4971 : 2007) associated with refurbishment, for an y type of m edical im aging equipm ent it wishes to process This determination shall consider the following items: a) b) c) d) e) intended use and norm al use of the equipm ent; expected service life; applicable standards; service/m aintenance history for the equipment; existing procedures for the refurbishment of m edical im aging equipment, such as service, repair, production, and maintenance Used m edical im aging equipm ent that is at the end of expected service life or that cannot be restored to at least the original safety and performance levels, including all m andatory safety updates, shall not be refurbished 5.3 Evaluating market access requirements To ensure regulatory compliance, the refurbisher shall have a process in place to evaluate market access requirements, such as valid registrations and licenses or restrictions, and to provide instructions for use in the appropriate languages, safety inform ation, warnings, and labels Refurbished medical imaging equipm ent for which the registrations or licenses of the original or refurbished m edical im aging equipment have been discontinued or where there is no original license may require the refurbisher to obtain a valid registration prior to comm ercialization 5.4 Preparation for refurbishment, disassembly, packing, and shipment The refurbisher shall have procedures in place to ensure that the m edical imaging equipm ent has been suitabl y cleaned and disinfected to avoid harm ing an y person involved in the disassembly, packing, and shipm ent The m edical imaging equipm ent shall be adequatel y I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I EC PAS 63077:201 © I EC 201 – 11 – disassem bled (if necessary) and packed to prevent damage during shipment Appropriate procedures shall be in place to avoid violation of privacy rules concerning patient data possibl y stored on the relevant equipm ent 5 Pl an n i n g A refurbishm ent plan shall be developed and followed to restore the medical im aging equipm ent to a condition of safety and effectiveness com parable to when new I n s ta l l a ti o n o f s a fe t y u p d a t e s ( h a rd w a re /s o ft w a re ) The refurbisher shall install all safety updates released by the m anufacturer for the relevant medical im aging equipment since it was placed on the m arket P e rfo rm a n c e a n d s a fe t y t e s t Tests specified for the original medical imaging equipm ent shall be conducted to verify that original perform ance and safety specifications are m et, including all m andatory safety updates P a c ki n g , s h i p m e n t, an d i n stal l ati on o f re fu rb i s h e d m ed i cal i magin g eq u i pm en t Packing and shipm ent shall be adequate to prevent damage during transit and load/unload operations I nstallation, inspection, and an y required testing shall be perform ed according to docum ented procedures of the manufacturer Re c o rd o f re fu rb i s h m e n t The record shall reflect for the relevant m edical imaging equipment that all operations and processes described in the refurbishment plan have been accom plished I n addition, the record of refurbishment is specificall y required to contain, or refer to the location of, the following inform ation: a) b) c) d) date of refurbishment; an y m edical imaging equipm ent identification and control num bers used; the prim ary identification label and labelling used for each refurbished unit; the acceptance records that dem onstrate that the equipment has been refurbished in accordance with the refurbishment plan; e) list of replaced parts and their identification informati on The record shall authenticate an y refurbished m edical im aging equipm ent through m eans that allow inspection by authorities and verification by custom ers as requested R e fu rb i s h m e n t l a b e l The refurbisher shall label all refurbished medical imaging equipment in proxim ity to the original label identifying that the medical imaging equipment has been refurbished by the refurbisher and the date of refurbishment I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n – 12 – I EC PAS 63077:201 © I EC 201 Bibliography I EC 60601 -1 : 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance I EC 60601 -1 : 2005/AMD1 :201 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment I EC 62353: 201 4, US FDA 21 CFR Part 820 Quality System Regulation, Title 21 – Food and drugs – Chapter I – Food and drug administration department of health and human services – Subchapter H – Medical devices – Part 820: Quality system regulation _ I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n I N TE RN ATI O N AL E LE CTRO TE CH N I CAL CO M M I S S I O N 3, ru e d e Va re m bé P O B ox CH -1 1 G e n e va S wi tze rl a n d Te l : + 41 F a x: + 22 91 02 1 22 91 03 00 i n fo @i e c ch www i e c ch I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n