BS EN IEC 63077:2019 pdf download

BS EN IEC 63077:2019 pdf download.Good refurbishment practices for medical imaging equipment.
3 Terms 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:llwww.eloctropedia.orgl
• ISO Online browsing platform: available at http:!twww.iso.orgiobp
3.1
EXPECTED SERVICE LIFE
time period specified by Ihe MANUFACTURER during which the medical electncal equipment or medical electrical system is expected to remain safe for use (I.e. maintain basic safety and essenhal performance)
Note Ito entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE. [SOURCE: IEC 60601-1:2005!AMD1:2012. 3.281
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
Note ito efltr. TLNDEU UuE should no4 be confused with NORMAL USE. Whie both include the oncept of e as intended by he UANUFACTURSR. INTENDED USE focus.s on lb. ni.dical purpose while NORMAl. USE incorporal.s not only the medical purpose, but maintenance, transport. etc. as well.
[SOURCE: IEC 60601-1 :2005!AMDI :2012. 3.441
3.3
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging, labelling, assembling, or adapting MEDICAL IMAGING EOUIPMENT. regardless of whether these operations are performed by that person or on that persons behalf by a third party
Note I to entry Adapting includes making substantial modifications to MEDiCAL iMAGING EQUIPMENT already in use
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.55, modified — The term MEDICAL IMAGING EQUIPMENT is replacing ME EQUIPMENT or ME SYSTEM in the definition and in the Note to entry, and three Notes to entry have been deleted.J
3.4
MEDICAL IMAGING EQUIPMENT
medical electrical equipment that provides images for clinical applications
Note ito entry’ S.. lEG 50601-1 2005. 363 for a d•fenition of MEDICAL ELECTICM. EOUIPMENT
3.5
NORMAL USE
operation, including routine inspection and adjustments by any OPERATOR, and stand-by, according to the instructions for use
Note ito entry: iIORMAI, USE ehould not be confused with INTENDED USE. Whiie both Include the concspl of use as Intended by tile MANUFACTURER, IFITENOED USE focuee’s Ofl tile medical purpose while NORMAl. USE incorporates not only th, medical purpose, but maintenance. Iransporl, etc. as well.
[SOURCE: IEC 60601-1:2005!AMDI :2012. 3.71]
3.8
OPERATOR
person handling the MEDICAL IMAGING EQUIPMENT
[SOURCE: IEC 60601-1:2005, 3,73, modified — Equipment was replaced by medical imaging equipmenr.]
3-7
REFURBISHER
natural or legal person who conducts REFURBISHMENT of MEDICAL IMAGING EQUIPMENT
Note 1 to entry: In some iurisdictaons. the responsible REFURBISHER can be considered as IdANUFACTURER when Involved In the activItIes descflbed.
3.8
PATIENT
living being (person or animal) undergoIng a medical, surgIcal or dental procedure
Note ito entry: A PATIENT can be an OpEpAlop
[SOURCE: IEC 60601-1:2005!AMD1:2012. 3.761
3-9
PROCESS
set of inter-related or interacting activities which transforms inputs into outputs
[SOURCE: IEC 60501-1 :2005!AMD1 :2012. 3.89)
3.10
PRODUCT
result of PROCESS
[SOURCE: ISO 13485:2016, 3,15)
3.11
REFURBISHMENT
PROCESS or combination of PROCESSES applied during the EXPECTED SERVICE LIFE to restore
USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance according to the
specification of the MANUFACTURER.
Note 1 to entry REFURBISHMENT can include activities such as REPAiR. REWORK, replacement ol worn parts, and update of software?hardware but does not include activities that result In the need of a new certification of the MEDICAL %IA0ING E0U1PBwNT and a legal MANUFACTURER status ol the REFuRBISMER
Note 2 to entry R5FURS1SHMEr4T does not include restoration after the EXPECTED SERVICE LIFE.
Note 3 to entry: In some lunad.ctlons a delinition 01 the term remanutacturer is available, REFuRBISHMENT differs from actions related to REFURBISHER acting in the role of a remenufeciurer,
Note 4 to entry In some junsdiclvons e definition of the term reprocessing is available In those JurisdIctions the term reprocessing is typically retated to reusable medical devices such as sAngte-use medical devices and is related to processes such as sterilIzatIon. REFUR5ISHMENT is different from reprocessing.
Note S to entry: REFURBISHMENT may result in a higher level of safety because e.g. safety updates released by the MANUFACTURER for the relevant MEDICAL IMAG*dG EQUIPMENT ere applied within REFuM5ISHMENT
3.12
REPAIR
means for restoring to a safe, functional, normal condition
[SOURCE: IEC 62353:2014. 3.39].