Code of Federal Regulations Title 21. Food and Drugs § 21.890.3930 Wheelchair elevator

(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA–recognized edition of 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 platform in the event of a device failure;

(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA–recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;

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

(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.