CEI EN 60601-1-10/A2:2022
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Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Hardcopy , PDF
English
01-04-2022
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) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.
DocumentType |
Amendment
|
ISBN |
978-2-8322-8622-7
|
Pages |
20
|
PublisherName |
Comitato Elettrotecnico Italiano
|
Status |
Current
|
Standards | Relationship |
IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV | Identical |
EN 60601-1-10:2008/A2:2021 | Identical |
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