IEC 60601-1-10:2013 pdf free download.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.
The use of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS are expected to provide a successful strategy to improve PATIENT safety and reduce healthcare costs [9][1O][11][12][13]. New RISKS that are not directly addressed by previous standards are emerging in the development of this equipment. MANUFACTURERS employ a variety of methods to validate the safety and integrity of control systems with varying degrees of success. Classical methods of software VALIDATION for PHYSIOLOGIC CLOSED-LOOP CONTROLLERS can be insufficient to ensure performance with acceptable RISKS under all clinical and physiologic conditions.
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 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.
1.2 Object
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 IEC 60601 -1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements lEG 60601 -1.