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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oSIST prEN IEC 63120:2021
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oSIST prEN IEC 63120:2021
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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oSIST prEN IEC 63120:2021
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 .
...
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