IEC 63077 pdf – Good refurbishment practices for medical imaging equipment

IEC 63077 pdf – Good refurbishment practices for medical imaging equipment
scope
This document describes and defines the PROCESs of REFURBISHMENT of uSED MEDICALIMAGINGEQUIPMENT and applies to the restoring of uSED MEDICALIMAGING EQUIPMENT to a condition ofsafety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e.MEDICALIMAGING EQUIPMENT that was not in use.This restoration includes actions such as REPAIR,REWORK，software/hardware updates,and the replacement of worn parts with original parts.This document enumerates the actions,that are performed, and the manner consistent,withrelevant specifications and service procedures required to ensure that the REFURBISHMENT ofMEDICAL lMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGINGEQUIPMENT’s performance,safety specifications,or INTENDED uSE according to its original orapplicable valid registration.
The MEDICAL IMAGING EQUIPMENT and systems covered by this document include:-X-RAY EQUIPMENT;
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES;×-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY;
MAGNETIC RESONANCE EQUIPMENT;
ULTRASONIC DIAGNOSTIC EQUIPMENT;GAMMA CAMERAS;
PLANAR WHOLEBODY IMAGING EQUIPMENT;
equipment for sINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT);
SPECT/cT hybrid systems，combining a GAMMA CAMERA with x-RAY EQUIPMENT FORcOMPUTED TOMOGRAPHY (CT);
POSITRON EMISSION TOMOGRAPHS (PET);
PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with x-RAY EQUIPMENTFOR COMPUTED TOMOGRAPHY (CT);
PET/MRl hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETICRESONANCE EQUIPMENT; and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.
This document does not apply to endoscopic equipment,funduscopic equipment,radiationtherapy equipment,nor associated systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of theircontent constitutes requirements of this document. For dated references,only the editioncited applies. For undated references, the latest edition of the referenced document (includingany amendments) applies.
ISO 13485:2016，Medical devices – Quality management systems – Requirements forreaulatorv purposes
3Terms and definitions
For the purposes of this document, the following terms and definitions apply.
IsO and lEC maintain terminological databases for use in standardization at the followingaddresses:
.IEC Electropedia: available at http://www.electropedia.orgl
. Iso Online browsing platform: available at http://www.iso.orglobp3.1
EXPECTED SERVICE LIFE
time period specified by the MANUFACTURER during which the medical electrical equipment ormedical electrical system is expected to remain safe for use (i.e. maintain basic safety andessential performance)
Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE.[SOURCE: IEC 60601-1:2005/AMD1:2012,3.28]
3.2
INTENDED UsE
lNTENDED PURPOSE
use for which a PRODUCT，PROCESS,or service is intended according to the specifications,instructions and information provided by the MANUFACTURER
Note 1 to entry: lINTENDED usE should not be confused with NORMAL USE.While both include the concept of use asintended by the MANUFACTURER,INTENDED usE focuses on the medical purpose while NORMAL UsE incorporates notonly the medical purpose, but maintenance,transport, etc. as well.
[SOURCE: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 EQuUIPMENT,regardless of whether these operationsare performed by that person or on that person’s behalf by a third party
Note 1 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 IMAGINGEQuUIPMENT is replacing ME EQUIPMENT or ME sYSTEM in the definition and in the Note to entry,and three Notes to entry have been deleted.]
3.4
MEDICAL IMAGING EQUIPMENT
medical electrical equipment that provides images for clinical applications
Note 1 to entry: See lEC 60601-1:2005,3.63 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 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 :201 2, 3.71 ]
3.6
OPERATOR
person handling the MEDICAL IMAGING EQUIPMENT
[SOURCE: IEC 60601 -1 :2005, 3.73, modified – “Equipment” was replaced by “medical imaging equipment”.]