CENELEC - EN 60601-1-10
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
|Publication Date:||1 April 2008|
|ICS Code (Medical equipment):||11.040|
This I nternational Standard a pplies to t he BASIC SAFETY a nd ESSENTIAL PERFORMANCE o f MEDICAL ELECTRICAL E QUIPMENT and MEDICAL ELECTRICAL S YSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for the development (analysis, design, VERIFICATION a nd VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP C ONTROLLER (PCLC) as part o f a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT a nd ME SYSTEMS t o control a PHYSIOLOGIC VARIABLE.
NOTE A PHYSIOLOGIC VARIABLE c an be a body c hemistry (e.g. electrolytes, blood glucose), a p hysical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.
This collateral standard a pplies t o various t ypes o f PCLC, e.g. linear and n on-linear, adaptive, fuzzy, neural networks.
This collateral standard does not specify:
− additional mechanical requirements; or
− additional electrical requirements.
This c ollateral standard a pplies to a closed-loop controller (see Figure 1 ) that sets the CONTROLLER OUTPUT VARIABLE in order t o adjust (i.e., change or maintain) t he m easured 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.
The object o f this c ollateral s tandard is to s pecify general r equirements that are in addition t o those of the general standard and to serve as the basis for particular standards.