EN IEC 63077:2019 pdf download

EN 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.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.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 3.6 OPERATOR person handling the MEDICAL IMAGING EQUIPMENT [SOURCE: IEC 60601 -1 :2005, 3.73, modified – “Equipment” was replaced by “medical imaging equipment”.] 3.7 REFURBISHER natural or legal person who conducts REFURBISHMENT of MEDICAL IMAGING EQUIPMENT Note 1 to entry: In some jurisdictions, the responsible REFURBISHER can be considered as MANUFACTURER when involved in the activities described. 3.8 PATIENT living being (person or animal) undergoing a medical, surgical or dental procedure Note 1 to entry: A PATIENT can be an OPERATOR . [SOURCE: IEC 60601 -1 :2005/AMD1 :201 2, 3.76] 3.9 PROCESS set of inter-related or interacting activities which transforms inputs into outputs [SOURCE: IEC 60601 -1 :2005/AMD1 :201 2, 3.89] 3.1 0 PRODUCT result of PROCESS [SOURCE: ISO 1 3485:201 6, 3.1 5] 3.1 1 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 of worn parts, and update of software/hardware but does not include activities that result in the need of a new certification of the MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the REFURBISHER . Note 2 to entry: REFURBISHMENT does not include restoration after the EXPECTED SERVICE LIFE . Note 3 to entry: In some jurisdictions a definition of the term remanufacturer is available. R EFURBISHMENT differs from actions related to REFURBISHER acting in the role of a remanufacturer. Note 4 to entry: In some jurisdictions a definition of the term reprocessing is available. In those jurisdictions the term reprocessing is typically related to reusable medical devices such as single-use medical devices and is related to processes such as sterilization. REFURBISHMENT is different from reprocessing. Note 5 to entry: REFURBISHMENT may result in a higher level of safet