oSIST prEN IEC 63120:2021
(Main)Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle
Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle
This document describes the REFURBISHMENT PROCESS following risk management concepts for the REFURBISHMENT of MEDICAL ELECTRICAL EQUIPMENT (MEE), MEDICAL ELECTRICAL SYSTEMS (MES) - which are covered by the IEC 60601 series of standards - or SUB-ASSEMBLIES and the RE-USE of COMPONENTS as a possibility for an extended life cycle for MEE/MES.
Applying this PROCESS to used MEE/MES and SUB-ASSEMBLIES as defined in this document ensures compliance to BASIC SAFETY and ESSENTIAL PERFORMANCE of the refurbished MEE and MES including their SUB-ASSEMBLIES.
This document also covers REFURBISHED SUB-ASSEMBLIES for re-use during the EXTENDED LIFE CYCLE of ME EQUIPMENT and ME SYSTEMS, and RE-USE of used COMPONENTS.
This document does not cover
- medical imaging equipment in the scope of IEC 63077:2019, including their SUB-ASSEMBLIES and COMPONENTS;
- repair, maintenance and servicing of ME EQUIPMENT or ME SYSTEM covered by IEC 60601-1 and IEC 62353;
- unauthorized modification of ME EQUIPMENT or ME SYSTEM or parts of such equipment/systems;
- environmental conscious design covered by IEC 60601-1-9 or IEC 62430;
- environmental aspects covered by the ISO TC 207 standards and waste treatment covered by IEC TC 111 standards;
- REFURBISHMENT of limited multiple use devices or parts of such devices;
- REFURBISHMENT of single use devices or parts of such devices;
- REFURBISHMENT of COMPONENTS.
Aufarbeitung von medizinischen elektrischen Geräten, medizinischen elektrischen Systemen und Baugruppen und Wiederverwendung von Bauteilen als Teil des verlängerten Lebenszyklus
Reconditionnement des appareils électromédicaux, des systèmes et sous-ensembles électromédicaux et réutilisation des composants dans le cadre du cycle de vie étendu
Prenovitev medicinske električne opreme, medicinskih električnih sistemov in podsestavov ter ponovna uporaba komponent za podaljšanje življenjskega cikla
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 63120:2021
01-marec-2021
Prenovitev medicinske električne opreme, medicinskih električnih sistemov in
podsestavov ter ponovna uporaba komponent za podaljšanje življenjskega cikla
Refurbishment of medical electrical equipment, medical electrical systems and sub-
assemblies and reuse of components as part of the extended life-cycle
Aufarbeitung von medizinischen elektrischen Geräten, medizinischen elektrischen
Systemen und Baugruppen und Wiederverwendung von Bauteilen als Teil des
verlängerten Lebenszyklus
Reconditionnement des appareils électromédicaux, des systèmes et sous-ensembles
électromédicaux et réutilisation des composants dans le cadre du cycle de vie étendu
Ta slovenski standard je istoveten z: prEN IEC 63120:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
13.020.60 Življenjski ciklusi izdelkov Product life-cycles
oSIST prEN IEC 63120:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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62A/1424/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 63120 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-01-08 2021-04-02
SUPERSEDES DOCUMENTS:
62A/1379/CDV, 62A/1399A/RVC
IEC SC 62A: COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
SECRETARIAT: SECRETARY:
USA Ms Hae choe
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 56,SC 62B,SC 62C,SC 62D
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
TITLE:
Extension of the life cycle of medical electrical equipment, medical electrical systems and sub-
assemblies by refurbishing and by re-use of components
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
Frei verwendbar
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it,
for any other purpose without permission in writing from IEC.
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IEC CDV 63120 © IEC:2020 – 2 – 62A/1424/CDV
1 CONTENTS
2
3 FOREWORD . 3
4 INTRODUCTION . 5
5 1 Scope . 7
6 2 Normative references . 7
7 3 Terms and definitions . 8
8 4 REFURBISHMENT PROCESSES for MEE/MES and SUB-ASSEMBLIES . 12
9 4.1 General requirements for REFURBISHMENT. 12
10 4.2 REFURBISHMENT PROCESS . 13
11 4.3 REFURBISHMENT PLAN . 13
12 4.4 RISK MANAGEMENT for REFURBISHMENT . 14
13 4.4.1 Current RISK MANAGEMENT FILE . 14
14 4.4.2 Identification of new HAZARDS foreseeable from REFURBISHMENT . 14
15 4.4.3 Risk evaluation . 15
16 4.5 Selection criteria for MEE/MES AND SUB-ASSEMBLIES suitable for
17 REFURBISHMENT . 15
18 4.6 Acceptance criteria for MEE/MES and SUB-ASSEMBLIES for REFURBISHMENT . 16
19 4.7 REFURBISHMENT workflow and instructions . 16
20 4.8 REFURBISHMENT RECORD for MEE/MES AND SUB- ASSEMBLIES . 16
21 4.9 Labelling of REFURBISHED MEE/MES . 17
22 4.9.1 REFURBISHMENT review . 17
23 4.9.2 Labelling of REFURBISHED MEE/MES . 17
24 4.9.3 Labelling of REFURBISHED SUB-ASSEMBLIES . 18
25 4.10 REFURBISHMENT FILE for MEE/MES and SUB-ASSEMBLY . 18
26 5 RE-USE of COMPONENTS . 19
27 6 Use of REFURBISHED SUB-ASSEMBLIES and RE-USE of cOMPONENTS in manufacturing
28 new ME EQUIPMENT and ME SYSTEMS . 19
29 Annex A (informative) EXTENDED LIFE CYCLE . 20
30 Annex B (informative) IEC 60601 series of medical standards related to REFURBISHED
31 ME EQUIPMENT . 21
32 ANNEX C (informative) REFURBISHMENT workflow for SUB-ASSEMBLIES . 22
33 ANNEX D (informative) Symbol for REFURBISHED SUB-ASSEMBLIES and MEE/MES . 23
34 ANNEX E (informative) RE-USE of COMPONENTS PROCESS. 24
35 RE-USE of COMPONENTS . 24
36 Bibliography . 25
37
38 Figure 1 – Relationship between MES, MEE, SUB-ASSEMBLY and COMPONENTS in the
39 context of this document . 6
40 Figure C.1 – REFURBISHMENT of SUB-ASSEMBLIES . 22
41 Figure D.1 – Symbol for REFURBISHED MEE/MES . 23
42
43 Table 1 – Examples of foreseeable REFURBISHMENT HAZARDS . 15
44 Table B.1 – Chronology of the IEC 60601-1 standard . 21
45
46
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47 INTERNATIONAL ELECTROTECHNICAL COMMISSION
48 ____________
49 Extension of the life cycle of medical electrical equipment, medical
50 electrical systems and sub-assemblies by refurbishing and by re-use of
51 components
52
53
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
57 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in
58 addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
59 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
60 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
61 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
62 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
63 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
64 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
65 consensus of opinion on the relevant subjects since each technical committee has representation from all
66 interested IEC National Committees.
67 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
68 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
69 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
70 misinterpretation by any end user.
71 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
72 transparently to the maximum extent possible in their national and regional publications. Any divergence between
73 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
74 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
75 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
76 services carried out by independent certification bodies.
77 6) All users should ensure that they have the latest edition of this publication.
78 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
79 members of its technical committees and IEC National Committees for any personal injury, property damage or
80 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
81 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
82 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
83 indispensable for the correct application of this publication.
84 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
85 rights. IEC shall not be held responsible for identifying any or all such patent rights.
86 International Standard IEC 63120 has been prepared by subcommittee 62A: Common aspects
87 of electrical equipment used in medical practice, of IEC technical committee 62: Electrical
88 equipment in medical practice.
89 The text of this standard is based on the following documents:
FDIS Report on voting
62A/XXXX/FDIS 62A/XXXX/RVD
90
91 Full information on the voting for the approval of this standard can be found in the report on
92 voting indicated in the above table.
93 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
94 In this document the following print types are used:
95 – requirements and definitions: roman type;
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96 – informative material, such as notes, examples and references: smaller type;
97 – TERMS DEFINED IN CLAUSE 3 OR AS NOTED: SMALL CAPITALS.
98 The committee has decided that the contents of this document will remain unchanged until the
99 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
100 the specific document. At this date, the document will be
101 • reconfirmed,
102 • withdrawn,
103 • replaced by a revised edition, or
104 • amended.
105
106 The National Committees are requested to note that for this document the stability date
107 is 2025.
108 THIS TEXT IS INCLUDED FOR THE INFORMATION OF THE NATIONAL COMMITTEES AND WILL BE DELETED
109 AT THE PUBLICATION STAGE.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.
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110 INTRODUCTION
111 The aim of this document is to support a MANUFACTURER or a REFURBISHER of MEDICAL ELECTRICAL
112 EQUIPMENT (MEE) and MEDICAL ELECTRICAL SYSTEMS (MES) with a framework within which
113 experience, insight and judgment are applied systematically to manage the HAZARDS associated
114 with REFURBISHMENT activities. It deals with PROCESSES for managing HAZARDS, primarily to the
115 patient, but also the operator and other persons.
116 The principles of RISK MANAGEMENT for Medical Devices which are specified in ISO 14971 are
117 not modified by this document; the aim of REFURBISHMENT is to contribute to circular economy
118 aspects for MEDICAL ELECTRICAL EQUIPMENT (MEE) or MEDICAL ELECTRICAL SYSTEMS (MES) and to
119 support material efficiency to improve the environmental aspects of MEE and MES. This document
120 specifies the necessary additional RISK MANAGEMENT steps. These are used to extend the life
121 cycle of MEE/MES to at least one second lifetime. While circular economy plays a key role to
122 contribute to the environmental impact, BASIC SAFETY and ESSENTIAL PERFORMANCE of MEE/MES
123 may not be compromised.
124 A key element for refurbishing of MEE/MES is that they are constructed and manufactured to an
125 environmental conscious design that enables REFURBISHMENT. IEC 60601-1-9 or IEC 62430 can
126 be substantial contributors to this goal.
127 REFURBISHERS of used MEE/MES should be certified under a quality management system such
128 as ISO 13485:2016 or equivalent for REFURBISHMENT.
129 Compliance with ISO 13485 is not sufficient to demonstrate that a RISK MANAGEMENT PROCESS
130 compliant with ISO 14971 requirements is performed for REFURBISHMENT of MEE/MES. There can
131 be no investigation to IEC 60601 series without the MANUFACTURER’S RISK MANAGEMENT FILE
132 being available.
133 An important aspect of REFURBISHMENT is that normally the ownership of the MEE/MES can
134 change from the first owner to the REFURBISHER and then to a second owner whereas for repair,
135 maintenance and servicing the ownership does not change normally.
136 SUB-ASSEMBLIES refurbished according to this document can also be used for new MEE/MES.
137 MANUFACTURER of the MEE/MES should consider the obligation to inform his customers about the
138 status of RE-USED COMPONENTS or refurbished SUB-ASSEMBLIES in the MEE/MES delivered.
139 Figure 1 shows the relation between COMPONENTS, SUB-ASSEMBLIES, MEE or MES where the main
140 difference is that for COMPONENTS, the MANUFACTURER does not have the design control making
141 it impossible for a MANUFACTURER to refurbish COMPONENTS. The MANUFACTURER can only RE-
142 USE COMPONENTS.
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143
144
145 Figure 1 – Relationship between MES, MEE, SUB-ASSEMBLY and COMPONENTS in the context
146 of this document
147
148 For the purposes of this document, the auxiliary verb:
149
150 – “shall” means that conformance with a requirement or a test is mandatory for conformance
151 with this document;
152 – “should” means that conformance with a requirement or a test is recommended but is not
153 mandatory for conformance with this document;
154 – “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
155 requirement or test);
156 – "can" is used to describe a possibility or capability; and
157 – "must" is used to express an external constraint.
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158 EXTENSION OF THE LIFE CYCLE OF MEDICAL ELECTRICAL EQUIPMENT,
159 MEDICAL ELECTRICAL SYSTEMS AND SUB-ASSEMBLIES BY
160 REFURBISHING AND BY RE-USE OF COMPONENTS
161
162 1 Scope
163 This document describes the REFURBISHMENT PROCESS following risk management concepts for
164 the REFURBISHMENT of MEDICAL ELECTRICAL EQUIPMENT (MEE), MEDICAL ELECTRICAL SYSTEMS (MES)
165 - which are covered by the IEC 60601 series of standards - or SUB-ASSEMBLIES and the RE-USE
166 of COMPONENTS as a possibility for an extended life cycle for MEE/MES.
167 Applying this PROCESS to used MEE/MES and SUB-ASSEMBLIES as defined in this document
168 ensures compliance to BASIC SAFETY and ESSENTIAL PERFORMANCE of the refurbished MEE and
169 MES including their SUB-ASSEMBLIES.
170 This document also covers REFURBISHED SUB-ASSEMBLIES for re-use during the EXTENDED LIFE
171 CYCLE of ME EQUIPMENT and ME SYSTEMS, and RE-USE of used COMPONENTS.
172 This document does not cover
173 • medical imaging equipment in the scope of IEC 63077:2019, including their SUB-
174 ASSEMBLIES and COMPONENTS;
175 • repair, maintenance and servicing of ME EQUIPMENT or ME SYSTEM covered by IEC
176 60601-1 and IEC 62353;
177 • unauthorized modification of ME EQUIPMENT or ME SYSTEM or parts of such
178 equipment/systems;
179 • environmental conscious design covered by IEC 60601-1-9 or IEC 62430;
180 • environmental aspects covered by the ISO TC 207 standards and waste treatment
181 covered by IEC TC 111 standards;
182 • REFURBISHMENT of limited multiple use devices or parts of such devices;
183 • REFURBISHMENT of single use devices or parts of such devices;
184 • REFURBISHMENT of COMPONENTS.
185 2 Normative references
186 The following documents are referred to in the text in such a way that some or all of their content
187 constitutes requirements of this document. For dated references, only the edition cited applies.
188 For undated references, the latest edition of the referenced document (including any
189 amendments) applies.
190 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
191 and essential performance
1
192 IEC 60601-1:2005/AMD1:2012 + IEC 60601-1:2005/AMD1:2012/AMD2:2020
193 IEC 62304, Medical device software – Software life cycle processes
194 IEC 62309:2004, Dependability of products containing reused parts – Requirements for
195 functionality and tests
196 ISO 13485:2016, Medical devices – Quality management systems – Requirements for
197 regulatory purposes
—————————
1
At publication stage [footnote to be deleted before publication]
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198 ISO 14971:2019, Medical devices – Application of risk management to medical devices
199 3 Terms and definitions
200 For the purposes of this document, the following terms and definitions apply.
201 ISO and IEC maintain terminological databases for use in standardization at the following
202 addresses:
203 • IEC Electropedia: available at http://www.electropedia.org/
204 • ISO Online browsing platform: available at http://www.iso.org/obp
205
206 3.1
207 BASIC SAFETY
208 freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is
209 used under normal condition and single fault condition
210 Note 1 to entry: ”Normal condition” and “single fault condition” are defined terms in IEC 60601-1.
211 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020: 3.10, modified –Note 1 to entry added.]
212 3.2
213 COMPONENT
214 element of a SUB-ASSEMBLY that cannot be meaningfully decomposed any further
215 Note 1 to entry: Example: A separate part of a printed circuit board assembly that performs a circuit function, e.g.
216 a resistor, a capacitor, a transistor, etc.
217 3.3
218 ESSENTIAL PERFORMANCE
219 performance of a clinical function, other than that related to BASIC SAFETY, where loss or
220 degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK
221 Note 1 to entry: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or
222 degradation would result in an unacceptable RISK.
223 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020: 3.27]
224 3.4
225 EXPECTED SERVICE LIFE
226 time period specified by the MANUFACTURER during which the ME EQUIPMENT, ME SYSTEM or SUB-
227 ASSEMBLIES are expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL
228 PERFORMANCE)
229 Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE.
230 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020: 3.28]
231 3.5
232 EXTENDED SERVICE LIFE
233 time period specified by the REFURBISHER during which the ME EQUIPMENT, ME SYSTEM or SUB-
234 are expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL
ASSEMBLIES
235 PERFORMANCE) after REFURBISHMENT
236 Note 1 to entry: Maintenance can be necessary during the EXTENDED SERVICE LIFE.
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237 3.6
238 LIFE CYCLE
239 series of all phases in the life of a medical device, from the initial conception to final
240 decommissioning and disposal
241 [SOURCE: ISO/IEC Guide 63:2019, 3.5]
242 3.7
243 EXTENDED LIFE CYCLE
244 all phases in the life of a MEE/MES, from the initial conception, REFURBISHMENT, to final
245 decommissioning and disposal
246
247 3.8
248 HARM
249 injury or damage to the health of people, or damage to property or the environment
250 [SOURCE: ISO/IEC Guide 63:2019, 3.1]
251 3.9
252 HAZARD
253 potential source of HARM
254 [SOURCE: ISO/IEC Guide 63:2019, 3.2]
255 3.10
256 HAZARDOUS SITUATION
257 circumstance in which people, property, or the environment is/are exposed to one or more
258 hazards
259 [SOURCE: ISO/IEC Guide 63:2019, 3.3]
260 3.11
261 MANUFACTURER
262 natural or legal person with responsibility for the design, manufacture, packaging, or labelling
263 of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM,
264 regardless of whether these operations are performed by that person or on that person's behalf
265 by a third party
266 Note 1 to entry: ISO 13485 defines “labelling” as written, printed or graphic matter
267 – affixed to a medical device or any of its containers or wrappers, or
268 – accompanying a medical device,
269 related to identification, technical description, and use of the medical device, but excluding shipping documents. In
270 this standard, that material is described as markings and accompanying documents.
271 Note 2 to entry: “Adapting” includes making substantial modifications to ME EQUIPMENT or an ME SYSTEM already in
272 use.
273 Note 3 to entry: In some jurisdictions, the responsible organization can be considered a MANUFACTURER when
274 involved in the activities described.
275 Note 4 to entry: Adapted from ISO 14971: 2019, definition 3.9.
276 Note 5 to entry: “Accompanying documents” and “responsible organization” are defined terms in IEC 60601-1.
277 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.55 modified: Note 1: bibliographic
278 reference removed, Note 5 to entry added]
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279 3.12
280 MEDICAL ELECTRICAL EQUIPMENT
281 (ME EQUIPMENT OR MEE)
282 electrical equipment having an applied part or transferring energy to or from the patient or
283 detecting such energy transfer to or from the patient and which is:
284 a) provided with not more than one connection to a particular supply mains; and
285 b) intended by its MANUFACTURER to be used:
286 1) in the diagnosis, treatment, or monitoring of a patient; or
287 2) for compensation or alleviation of disease, injury or disability
288 E EQUIPMENT includes those accessories as defined by the MANUFACTURER that are necessary to
Note 1 to entry: M
289 enable the NORMAL USE of the ME EQUIPMENT.
290 Note 2 to entry: Not all electrical equipment used in medical practice falls within this definition (e.g. some in vitro
291 diagnostic equipment).
292 Note 3 to entry: The implantable parts of active implantable medical devices can fall within this definition, but they
293 are excluded from the scope of this standard.
294 Note 4 to entry: “Applied part”, “accessories”, “patient” and “supply mains” are defined term in IEC 60601-1.
295 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.63 modified: Notes to entry 4 and 5 deleted,
296 new Note 4 to entry added]
297 3.13
298 MEDICAL ELECTRICAL SYSTEM
299 (ME SYSTEM OR MES)
300 combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is
301 ME EQUIPMENT to be inter-connected by functional connection or by use of a multiple socket-
302 outlet
303 Note 1 to entry: Equipment, when mentioned in this standard, should be taken to include ME EQUIPMENT.
304 [SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.64]
305 3.14
306 PROCESS
307 set of interrelated or interacting activities that use inputs to deliver an intended result
308 Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the
309 context of the reference.
310 Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are
311 generally the inputs to other processes.
312 Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
313 [SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry 4, 5 and 6 deleted]
314 3.15
315 REFURBISHER
316 natural or legal person who conducts REFURBISHMENT of ME EQUIPMENT, ME SYSTEMS or SUB-
317 ASSEMBLIES
318 Note 1 to entry: Some country legislation requires that REFURBISHER is authorized or registered.
319 Note 2 to entry: In some jurisdictions, the responsible REFURBISHER can be considered as MANUFACTURER when
320 involved in the activities described.
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321 3.16
322 REFURBISHMENT
323 PROCESS applied under the responsibility of the REFURBISHER to restore used ME EQUIPMENT,
324 ME SYSTEM or SUB-ASSEMBLIES to a configuration released by the MANUFACTURER that has
325 documented compliance to BASIC SAFETY and ESSENTIAL PERFORMANCE comparable to when new
326 with the intention to extend the LIFE CYCLE
327
328 Note 1 to entry: REFURBISHMENT can include activities such as repair, rework, replacement of worn parts, and update
329 of software/hardware. It is important for the REFURBISHER to consider the status of regulatory submissions to national
330 authorities before a refurbished MEE/MES is placed on a national market.
331 Note 2 to entry: REFURBISHMENT according to this document is e.g. not meant when a MEE/MES has been shown on
332 a trade fair without use and then polished up for selling.
333 Note 3 to entry: The intention of REFURBISHMENT of ME EQUIPMENT, ME SYSTEM or SUB-ASSEMBLIES is the extension
334 of the EXPECTED SERVICE LIFE, defined by the MANUFACTURER under specified conditions to ensure that such kind of
335 refurbished ME EQUIPMENT, ME SYSTEM or SUB-ASSEMBLIES fulfils BASIC SAFETY and ESSENTIAL PERFORMANCE from the
336 IEC 60601 standard family.
337 Note 4 to entry: Some regulators may use the definition of REFURBISHMENT in different ways or use other terms.
338 3.17
339 REFURBISHMENT FILE
340 set of REFURBISHMENT RECORDS and other documents that are produced during REFURBISHMENT
341 based on the REFURBISHMENT PLAN as objective evidence that the REFURBISHMENT PLAN has been
342 completed
343 3.18
344 REFURBISHMENT PLAN
345 description of the activities needed for REFURBISHMENT of a specific ME EQUIPMENT, ME SYSTEM
346 or family of MEE/MES or SUB-ASSEMBLY IN accordance with this document
347 Note 1 to entry: The REFURBISHMENT PLAN is part of the REFURBISHMENT FILE.
348
349 3.19
350 REFURBISHMENT RECORD
351 REFURBISHMENT document(s) issued by the REFURBISHER stating results achieved or providing
352 evidence of activities performed on a particular MEE/MES or SUB-ASSEMBLY
353 3.20
354 REFURBISHED SUB-ASSEMBLY
355 SUB-ASSEMBLY that originates from refurbishment
356 Note 1 to entry: This includes used COMPONENTS that were not under the design control of the MANUFACTURER that
357 have been inspected or tested.
358 3.21
359 RE-USE
360 activity of recovering COMPONENTS and materials for further use without REFURBISHMENT
361 3.22
362 TECHNICAL SPECIFICATION
363 document that prescribes technical requir
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