Norm

NEN-EN-IEC 60601-1-12:2015 en

Medische elektrische apparatuur - Deel 1-12: Algemene eisen voor basisveiligheid en essentiƫle prestaties- Secundaire Norm: Eisen voor medische electrische apparatuur en medische electrische systemen die gebruikt worden voor de dringende medische hulpverlening

226,42

Over deze norm

Status Definitief
Aantal pagina's 101
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-IEC 60601-1-12 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1. The EMS ENVIRONMENT includes - responding to and providing life support at the scene of an emergency to a PATIENT reported as experiencing injury or illness in a pre-hospital setting, and transporting the PATIENT, while continuing such life support care, to an appropriate professional healthcare facility for further care. - providing monitoring, treatment or diagnosis during transport between professional healthcare facilities. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within the scope of this standard.

Details

ICS-code 11.040
Nederlandse titel Medische elektrische apparatuur - Deel 1-12: Algemene eisen voor basisveiligheid en essentiƫle prestaties- Secundaire Norm: Eisen voor medische electrische apparatuur en medische electrische systemen die gebruikt worden voor de dringende medische hulpverlening
Engelse titel Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

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