Norm

NEN-EN-IEC 60601-1-11:2015 en

Medische elektrische apparatuur - Deel 1-11: Algemene eisen voor basisveiligheid en essentiƫle prestatie - Secundaire Norm: Eisen voor medische electrische apparatuur en medische electrische systemen die gebruikt worden voor de medische verzorging in de thuissituatie

253,59

Over deze norm

Status Definitief
Aantal pagina's 125
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-IEC 60601-1-11 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. The HOME HEALTHCARE ENVIRONMENT includes: - the dwelling place in which a PATIENT lives; - other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.

Details

ICS-code 11.040
Nederlandse titel Medische elektrische apparatuur - Deel 1-11: Algemene eisen voor basisveiligheid en essentiƫle prestatie - Secundaire Norm: Eisen voor medische electrische apparatuur en medische electrische systemen die gebruikt worden voor de medische verzorging in de thuissituatie
Engelse titel Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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