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AAMI EQ93 - Medical equipment management - Vocabulary used in medical equipment programs
January 1, 2018 - AAMI

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...

ASTM E3173 - Standard Guide for Decommissioning and Disposal of Medical Equipment
July 1, 2018 - ASTM

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....

NEMA/MITA 2 - Requirements for Servicing of Medical Imaging Equipment
January 1, 2019 - NEMA

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...

DS/EN IEC 62667 - Medical electrical equipmentMedical light ion beam equipment – Performance characteristics
April 23, 2018 - DS

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...

IEC CISPR 11 - Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement
January 1, 2019 - IEC

This International Standard applies to industrial, scientific and medical electrical equipment operating in the frequency range 0 Hz to 400 GHz and to domestic and similar appliances designed to generate and/or use locally radio-frequency energy. This standard covers emission...

IEC 62667 - Medical electrical equipmentMedical light ion beam equipment – Performance characteristics
August 1, 2017 - IEC

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...

DIN EN ISO 19054 - Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016) (includes Amendment :2016)
April 1, 2017 - DIN

This International Standard specifies basic requirements to ensure compatibility between rail systems complying with this International Standard and medical equipment in order to facilitate the transfer of medical equipment from one rail system to another. The...

IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
October 1, 2018 - IEC

Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the...

IEC 61010-2-101 REDLINE - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
October 1, 2018 - IEC

Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the...

IEC PAS 63077 - Good refurbishment practices for medical imaging equipment
November 1, 2016 - IEC

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 effectiveness comparable to that of new equipment. This restoration...

SNZ AS/NZS 3551 - Management programs for medical equipment
October 31, 2012 - SNZ

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...

GOST R 57530 - Medical equipment for hyperbaric chambers under pressure. General technical requirements
January 1, 2017 - GOST
A description is not available for this item.
IEC TR 60601-4-2 - Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
May 1, 2016 - IEC

This part of IEC 60601 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of ELECTROMAGNETIC DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME...

DS/ISO 80601-2-61 - Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
February 4, 2019 - DS

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and...

CSA ISO/TR 13154 - Medical electrical equipment - Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
January 1, 2019 - CSA

This document provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection. NOTE The equipment...

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