BS EN IEC 63077:2019 pdf free
BS EN IEC 63077:2019 pdf free.Good refurbishment practices for medical imaging equipment.
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);
— PETIMRI 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2007, Medical devices — Application of risk management to medical devices
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 :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 I to entry. INTENDED USE should not be confused with NORMAL USE. While both include the concept ot 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 :2012, 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 persoWs behalf by a third party.BS EN IEC 63077 pdf free download.
