BS PD IEC PAS 63077-2016 Good refurbishment practices for medical imaging equipment《医学影像设备的良好改造实践》.pdf

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1、Good refurbishment practices for medical imaging equipment PD IEC/PAS 63077:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of IEC/PAS 63077:2016. The UK participation in its preparation was ent

2、rusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary prov

3、isions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 95743 7 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was

4、published under the authority of the Standards Policy and Strategy Committee on 30 November 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/PAS 63077:2016 IEC PAS 63077 Edition 1.0 2016-11 PUBLICLY AVAILABLE SPECIFICATION PRE-STANDARD Good refurbishm

5、ent practices for medical imaging equipment INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.55 ISBN 978-2-8322-3761-8 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. PD IEC/PAS 63077:2016

6、 2 IEC PAS 63077:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope 6 2 Normative references 6 3 Terms and definitions 6 4 General requirements for refurbishment of used medical devices 8 4.1 Quality management system . 8 4.2 Resource management . 8 4.3 Corrective and preventive action . 9

7、 4.4 Customer complaints 9 4.5 Production and service provision 9 4.6 Control of non-conforming product 9 4.7 Post-market surveillance process 9 4.8 Document control 9 4.9 Purchasing 9 4.10 Control of design and design changes 10 4.11 Risk management process 10 5 Specific requirements for good refur

8、bishment practice . 10 5.1 General . 10 5.2 Selection of medical imaging equipment for refurbishment 10 5.3 Evaluating market access requirements 10 5.4 Preparation for refurbishment, disassembly, packing, and shipment 10 5.5 Planning . 11 5.6 Installation of safety updates (hardware/software) 11 5.

9、7 Performance and safety test . 11 5.8 Packing, shipment, and installation of refurbished medical imaging equipment . 11 5.9 Record of refurbishment 11 5.10 Refurbishment label 11 Bibliography 12 PD IEC/PAS 63077:2016IEC PAS 63077:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GOOD REFU

10、RBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation

11、on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

12、Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparati

13、on. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus

14、 of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are m

15、ade to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications trans

16、parently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent c

17、ertification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability

18、 shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including

19、 legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this

20、 publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. A PAS is a technical specification not fulfilling the requirements for a stan

21、dard, but made available to the public. IEC PAS 63077 has been processed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this PAS is based on the following document: This PAS was approved for publication by the P

22、-members of the committee concerned as indicated in the following document Draft PAS Report on voting 62B/1022/PAS 62B/1030/RVC Following publication of this PAS, which is a pre-standard publication, the technical committee or subcommittee concerned may transform it into an International Standard. P

23、D IEC/PAS 63077:2016 4 IEC PAS 63077:2016 IEC 2016 This PAS shall remain valid for an initial maximum period of 3 years starting from the publication date. The validity may be extended for a single period up to a maximum of 3 years, at the end of which it shall be published as another type of normat

24、ive document, or shall be withdrawn. PD IEC/PAS 63077:2016IEC PAS 63077:2016 IEC 2016 5 INTRODUCTION Keeping up with the latest innovations in medical technology often involves replacing equipment in medical practice before it reaches the end of its expected service life. This is because innovation

25、cycles for medical technology are much shorter than the functional lifecycle of capital equipment. As a result, a sustainable resource management model is required: early replacement of installed medical imaging equipment by newer technology is more economically feasible if the residual value of the

26、 existing medical imaging equipment is utilized. Conserving assets is a fundamental principle of ecological thinking in a recycling economy. Several medical imaging equipment companies have already set up quality management systems to refurbish used medical imaging equipment and have delivered this

27、refurbished equipment across the healthcare sector for many years. Refurbishment addresses the high demand for affordable and reliable products. Customers of this used equipment are not only small hospitals with limited budgets but also leading medical institutes. The EU and the US represent by far

28、the two largest markets for refurbished medical equipment. Refurbishment of used medical imaging equipment is a well-established element of the healthcare economy. If used medical imaging equipment is not accurately maintained according to requirements defined by the manufacturer, it may result in a

29、dditional risk for patients and operators. Consequently, some countries have imposed bans on the importation of used medical imaging equipment to protect public health. These bans fail to distinguish between quality-assured refurbished medical imaging equipment and second-hand medical imaging equipm

30、ent of undefined quality, with the effect that patients may be denied access to the safe and economical medical imaging equipment they need. Safety and effectiveness are the most important aspects to consider with medical imaging equipment, including used equipment. To ensure safety and effectivenes

31、s, used medical imaging equipment has to be refurbished in a highly specialized and quality-assured way. PD IEC/PAS 63077:2016 6 IEC PAS 63077:2016 IEC 2016 GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT 1 Scope This document describes and defines the process of refurbishment of used med

32、ical 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 p

33、arts. 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 equipments performance, safety s

34、pecifications, or intended use according to its original or applicable valid registration. 2 Normative references 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 cite

35、d applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes ISO 14971:2007, Medical devices Application of risk management to medical devices 3 Ter

36、ms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at

37、http:/www.iso.org/obp 3.1 expected service life 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 performance) Note 1 to entry: Maintenance can be necessary

38、 during the expected service life. SOURCE: IEC 60601-1:2005/AMD1:2012, 3.28 3.2 intended use intended purpose use for which a product, process, or service is intended according to the specifications, instructions and information provided by the manufacturer PD IEC/PAS 63077:2016IEC PAS 63077:2016 IE

39、C 2016 7 Note 1 to entry: Intended use should not be confused with normal use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well. SOUR

40、CE: IEC 60601-1:2005/AMD1:2012, 3.44 3.3 manufacturer natural or legal person with responsibility for the design, manufacture, packaging, labelling, assembling, or adapting medical imaging equipment, regardless of whether these operations are performed by that person or on that persons behalf by a t

41、hird party Note 1 to entry: ISO 13485:2016 defines “labelling” as “written, printed or graphic matter as: a) affixed to a medical device or any of its containers or wrappers, or b) accompanying a medical device, related to identification, technical description, and use of the medical device, but exc

42、luding shipping documents. In this document, that material is described as markings and accompanying document. Note 2 to entry: Adapting includes making substantial modifications to medical imaging equipment already in use. Note 3 to entry: In some jurisdictions, the responsible refurbisher can be c

43、onsidered a manufacturer when involved in the activities described. Note 4 to entry: Adapted from ISO 14971:2007, 2.8. SOURCE: IEC 60601-1:2005/AMD1:2012, 3.55, modified The definition and Note 2 have been reworded. 3.4 medical imaging equipment medical electrical equipment that provides images for

44、clinical applications Note 1 to entry: See IEC 60601-1:2005/AMD1:2012, 3.63 for a definition of medical electrical equipment. 3.5 normal use operation, including routine inspection and adjustments by any operator, and stand-by, according to the instructions for use Note 1 to entry: Normal use should

45、 not be confused with intended use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well. SOURCE: IEC 60601-1:2005/AMD1:2012, 3.71 3.6 op

46、erator person handling the medical imaging equipment SOURCE: IEC 60601-1:2005/AMD1:2012, 3.73, modified The definition has been reworded. 3.7 refurbisher natural or legal person who conducts refurbishment of medical imaging equipment 3.8 patient living being (person or animal) undergoing a medical,

47、surgical or dental procedure Note 1 to entry: A patient can be an operator. PD IEC/PAS 63077:2016 8 IEC PAS 63077:2016 IEC 2016 SOURCE: IEC 60601-1:2005/AMD1:2012, 3.76 3.9 process set of inter-related or interacting activities which transforms inputs into outputs SOURCE: IEC 60601-1:2005/AMD1:2012,

48、 3.89 3.10 refurbishment process or combination of processes applied during the expected service life to restore used medical imaging equipment to a condition of safety and effectiveness comparable to when new Note 1 to entry: Refurbishment can include activities such as repair, rework, replacement

49、of worn parts, and update of software/hardware but shall not include activities that result in regulatory submissions. 3.11 repair means for restoring to a safe, functional, normal condition SOURCE: IEC 62353:2014, 3.39 3.12 rework action taken on a nonconforming product so that it will fulfill the specified Device Master Record requirements before it is released for distribution SOURCE: 21 CFR 820, 3 (x) 3.13 risk combination of the probability of occurrence of harm and the severity of that har