IEC 60601-1-10:2007 PDF

Scope: 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. NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes@ blood glucose)@ a physical property (e.g. PATIENT temperature@ electrophysiologic@ hemodynamic)@ or a pharmaceutical concentration. 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 controllerthat 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.

IEC 60601-1-10:2007 history

2020 IEC 60601-1-10:2007/AMD2:2020 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
2020 IEC 60601-1-10:2020 Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers CONSOLIDATED EDITION
2013 IEC 60601-1-10:2007/AMD1:2013 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; Amendment 1
2013 IEC 60601-1-10:2013 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
2007 IEC 60601-1-10:2007 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