1 Scope, object and related standards 84 1.1 Scope Replace the existing second paragraph and example with: 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. EXAMPLES A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a pharmaceutical concentration. 1.3 Related standard 1.3.1 IEC 60601-1 Replace the first two existing dashes with: "the general standard" designates IEC 60601-1 alone including any amendments; "this collateral standard" designates IEC 60601-1-10 alone including any amendments;