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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 16-203
Standard
ASME A18.1-2017
Safety Standard for Platform Lifts and Stairway Chairlifts
Scope/Abstract
This safety standard covers the design, construction, installation, operation, inspection, testing, maintenance, and repair of inclined stairway chairlifts and inclined and vertical platform lifts intended for transportation of a mobility impaired person only. The device shall have a limited vertical travel, operating speed, and platform area. Operation shall be under continuous control of the user/attendant. The device shall not penetrate more than one floor. A full passenger enclosure on the platform shall be prohibited.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
FDA Technical Contact
 Deborah Schoenfeld
  FDA/CDRH/CDRH/OPEQ/OHTV/DHTVB
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  Deborah.Schoenfeld@fda.hhs.gov
Standards Development Organization
ASME American Society of Mechanical Engineers https://www.asme.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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