1.1 Scope Replace the existing first paragraph with: This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. Replace the existing third paragraph with: If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance. 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 60601-1-6 alone including any amendments;