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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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:
Frei verwendbar
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
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IEC CDV 63120 © IEC:2020 – 2 – 62A/1424/CDV
1 CONTENTS
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
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
43 Table 1 – Examples of foreseeable REFURBISHMENT HAZARDS . 15
44 Table B.1 – Chronology of the IEC 60601-1 standard . 21
62A/1424/CDV – 3 – IEC CDV 63120 © IEC:2020
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
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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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
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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
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;
IEC CDV 63120 © IEC:2020 – 4 – 62A/1424/CDV
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
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101 • reconfirmed,
102 • withdrawn,
103 • replaced by a revised edition, or
104 • amended.
106 The National Committees are requested to note that for this document the stability date
107 is 2025.
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109 AT THE PUBLICATION STAGE.
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62A/1424/CDV – 5 – IEC CDV 63120 © IEC:2020
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 R
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