DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

SSH EN 60601-1-10:2008

Pajisjet elektromjekësore — Pjesa 1-10: Kërkesa të përgjithshme për sigurinë bazë dhe performance e nevojshme — Standard plotësues: Kërkesat për zhvillimin e rregulluesve fiziologjik me qark te mbyllur

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
29 tet 2008

General information

60.60     29 tet 2008

DPS

DPS/KT 6

European Norm

11.040  

anglisht  

Buying

Publikuar

Language in which you want to receive the document.

Scope

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 medical electrical equipment and medical electrical systems to control a physiologic variable.[<BR>]This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.[<BR>]This collateral standard applies to a closed-loop controller 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.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Të harmonizuara

Life cycle

NOW

PUBLISHED
SSH EN 60601-1-10:2008
60.60 Standard published
29 tet 2008

Related project

Adopted from EN 60601-1-10:2008

Adopted from IEC 60601-1-10 Ed. 1.0 b