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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 16-237
Standard
ASME  A18.1-2023
Safety Standard for Platform Lifts and Stairway Chairlifts
Scope/Abstract
The ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts presents certain guides for the design, construction, installation, operation, inspection, testing, maintenance, and repair of inclined stairway chairlifts, and inclined and vertical platform lifts. It covers devices intended for transportation of a mobility-impaired person only - typically within household applications. The ultimate goal of this Standard is to help protect public safety, while reflecting best-practices of industry.
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.
Transition Period
FDA recognition of ASME A18.1-2017 [Rec# 16-203] will be superseded by recognition of ASME A18.1-2023 [Rec# 16-237 ]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-203] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 16-203] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.5150 Transport, Patient, Powered Class 2 ILK
§890.5150 Powered Stairway Chair Lift Class 2 PCD
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Deborah Schoenfeld
  FDA/OC/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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