Norm

NEN-EN-IEC 60601-1-10:2008 en

Medische elektrische toestellen - Deel 1-10: Algemene eisen voor basisveiligheid en essentiƫle prestaties - Secundaire norm: Eisen voor de ontwikkeling van fysiologische gesloten regelaars

Volledig inclusief:

190,20

Over deze norm

Status Definitief
Aantal pagina's 79
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2008
Taal Engels
This International Standard 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. This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify: additional mechanical requirements; or additional electrical requirements. This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE. A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 1-10: Algemene eisen voor basisveiligheid en essentiƫle prestaties - Secundaire norm: Eisen voor de ontwikkeling van fysiologische gesloten regelaars
Engelse titel Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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