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This standard provides consensus definitions for key terms used in medical equipment management around the maintenance, repair and servicing of medical devices, so that all stakeholders involved in the regulation, management and use of medical devices have common...
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...
1.1 This standard guide addresses decommissioning and disposal of medical equipment. 1.2 Decommissioning and disposal of medical equipment is done when equipment is no longer needed due to obsolescence, is inoperable, or has met a scheduled replacement milestone....
IEC 63077:2019 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...
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...
This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term HAEMODIALYSIS is...
This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term HAEMODIALYSIS is...
This standard guide addresses decommissioning and disposal of medical equipment. Decommissioning and disposal of medical equipment is done when equipment is no longer needed due to obsolescence, is inoperable, or has met a scheduled replacement milestone....
IEC TR 62653:2020 is available as IEC TR 62653:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC TR 62653:2020 describes the technical recommendations for use of medical...
This Standard outlines procedures required to develop management programs for medical equipment. These include protocols and procedures for procurement, acceptance, maintenance activities throughout the service life of the medical equipment, and finally disposal of...
This document specifies the performance and testing of DOSE AREA PRODUCT METERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS. This document is applicable to the following types of DOSE AREA...
This Standard provides guidance on the correct function, safe use and application of electrically operated medical equipment used in healthcare. Although the Standard is concerned primarily with an electric shock hazard to patients and staff, provisions to safeguard against other...
This Standard describes and defines the minimum quality management system requirements for servicing of medical imaging equipment to ensure a return to a safe and effective condition for its intended use. Requirements determined by Authorities Having Jurisdiction (AHJ) take precedence...
This document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in human medical practice. This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n. This document...
IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice. This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n. This document...
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this...
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this...
