| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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6-407
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| Standard | |
ASTM F3186-17
Standard Specification for Adult Portable Bed Rails and Related Products |
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Scope/Abstract1.1 This safety specification establishes performance requirements for adult portable bed rails, related products, and adult portable bedrail accessories, including requirements for resistance to entrapment, marking and adhered labels, instructional literature, and advertising.
1.2 This standard is applicable to any such product (as defined below) that is not designed as part of the bed by the bed manufacturer, and is installed on, against or adjacent to the side of an adult bed and is for use by adults to reduce the risk of falling from the bed, assist in repositioning in the bed, assist in transitioning into or out of the bed, or other similar purposes as stated by the manufacturer.
1.3 This safety specification includes adult portable bed rails that meet the definition of a medical device and are therefore under the jurisdiction of the Food and Drug Administration (FDA), and adult portable bed rails that are not medical devices, and which therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC).2
1.4 This safety specification does not cover guardrails or side rails intended for use on FDA regulated hospital beds, or portable rails for children which are included in Consumer Safety Specification F1821 for toddler beds, Consumer Safety Specification F2085 for portable bed rails for children, or IEC 60601-2-52 for medical beds.
1.5 This safety specification is intended to minimize entrapment and strangulation hazards that are attributed to design components, whether these hazards arise from normal installation and use, reasonably foreseeable mis-installation/misuse, or changes to the stability of the attachment over time, or combinations thereof. Other hazards may exist (for example, falls) that are not within the scope of this specification. Such hazards will be the subject of additional standards.
1.6 No adult portable bed rail, or related product as defined in this specification, shall, either by label or other means, indicate compliance with this specification unless it conforms to all the requirements contained herein.
1.7 UnitsThe values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversion to SI units that are provided for information only and are not considered standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
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§890.5050
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Daily activity assist device. Adult Portable Bed Rails For Medical Purposes
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Class 1
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QTC
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Relevant FDA Guidance and/or Supportive Publications*
For additional information and guidance, please visit the CDRH Web Page on Hospital Beds.
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/hospital-beds
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
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