Code of Federal Regulations Title 21. Food and Drugs § 21.890.5150 Powered patient transport

(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA–recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;

(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;

(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA–recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);

(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA–recognized editions of AAMI/ANSI/IEC 60601–1–2, “Medical Electrical Equipment—Part 1–2:  General Requirements for Safety—Collateral Standard:  Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety;  and

(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.