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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 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.
Transition Period
FDA recognition of ASME A18.1-2014 [Rec# 16-193] will be superseded by recognition of ASME A18.1-2017 [Rec# 16-203]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-193] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 16-193] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 John Marszalek
  FDA/OMPT/CDRH/OC/DICO/FEB/
  301-796-7067
  john.marszalek@fda.hhs.gov
Standards Development Organization
ASME American Society of Mechanical Engineers https://www.asme.org/
FDA Specialty Task Group (STG)
Physical Medicine
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