scope:

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.

Object

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.