IEC 63077:2019 pdf download

IEC 63077:2019 pdf download.Good refurbishment practices for medical imaging equipment
1 Scope This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING 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, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT ’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.
The MEDICAL IMAGING EQUIPMENT and systems covered by this document include:
– X – RAY EQUIPMENT ;
– X – RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES ;
– X – 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 FOR COMPUTED TOMOGRAPHY ( CT );
– POSITRON EMISSION TOMOGRAPHS ( PET );
– PET / CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X – RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY ( CT );
– PET / MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT ; and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.
This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.
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://www.electropedia.org/ • ISO Online browsing platform: available at http://www.iso.org/obp 3.1 EXPECTED SERVICE LIFE time period specified by the MANUFACTURER during which the medical electrical equipment or medical electrical system is expected to remain safe for use (i.e. maintain basic safety and essential performance) Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE . [SOURCE: IEC 60601 -1 :2005/AMD1 :201 2, 3.28] 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 1 to entry: INTENDED USE should not be confused with NORMAL 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, 3.44] 3.3 MANUFACTURER natural or legal person with responsibility for the design, manufacture, packaging, labelling, assembling, or adapting MEDICAL IMAGING EQUIPMENT , regardless of whether these operations are 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 :201 2, 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.]3.4 MEDICAL IMAGING EQUIPMENT medical electrical equipment that provides images for clinical applications Note 1 to entry: See IEC 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 ]