ASTM F3186-24
(Specification)Standard Specification for Adult Portable Bed Rails and Related Products
Standard Specification for Adult Portable Bed Rails and Related Products
ABSTRACT
This safety specification establishes the 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. It 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. This specification applies to 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 to adult portable bed rails that are not medical devices, and which therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC).
SCOPE
1.1 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 Units—The 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.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3186 − 24
Standard Specification for
1
Adult Portable Bed Rails and Related Products
This standard is issued under the fixed designation F3186; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 No adult portable bed rail, or related product as defined
in this specification, shall, either by label or other means,
1.1 This safety specification establishes performance re-
indicate compliance with this specification unless it conforms
quirements for adult portable bed rails, related products, and
to all the requirements contained herein.
adult portable bedrail accessories, including requirements for
1.7 Units—The values stated in inch-pound units are to be
resistance to entrapment, marking and adhered labels, instruc-
regarded as standard. The values given in parentheses are
tional literature, and advertising.
mathematical conversion to SI units that are provided for
1.2 This standard is applicable to any such product (as
information only and are not considered standard.
defined below) that is not designed as part of the bed by the bed
1.8 This standard does not purport to address all of the
manufacturer, and is installed on, against, or adjacent to the
safety concerns, if any, associated with its use. It is the
side of an adult bed and is for use by adults to reduce the risk
responsibility of the user of this standard to establish appro-
of falling from the bed, assist in repositioning in the bed, assist
priate safety, health, and environmental practices and deter-
in transitioning into or out of the bed, or other similar purposes
mine the applicability of regulatory limitations prior to use.
as stated by the manufacturer.
1.9 This international standard was developed in accor-
1.3 This safety specification includes adult portable bed
dance with internationally recognized principles on standard-
rails that meet the definition of a medical device and are
ization established in the Decision on Principles for the
therefore under the jurisdiction of the Food and Drug Admin-
Development of International Standards, Guides and Recom-
istration (FDA), and adult portable bed rails that are not
mendations issued by the World Trade Organization Technical
medical devices, and which therefore fall under the jurisdiction
Barriers to Trade (TBT) Committee.
2
of the Consumer Product Safety Commission (CPSC).
2. Referenced Documents
1.4 This safety specification does not cover guardrails or
3
side rails intended for use on FDA regulated hospital beds, or 2.1 ASTM Standards:
D3359 Test Methods for Rating Adhesion by Tape Test
portable rails for children which are included in Consumer
Safety Specification F1821 for toddler beds, Consumer Safety F1821 Consumer Safety Specification for Toddler Beds
Specification F2085 for portable bed rails for children, or IEC F2085 Consumer Safety Specification for Portable Bed Rails
4
60601-2-52 for medical beds.
2.2 Federal Standards and Guidelines:
16 CFR 1500.48 Technical Requirements for Determining a
1.5 This safety specification is intended to minimize entrap-
Sharp Point in Toys and Other Articles Intended for Use
ment and strangulation hazards that are attributed to design
by Children Under 8 Years of Age
components, whether these hazards arise from normal instal-
16 CFR 1500.49 Technical Requirements for Determining a
lation and use, reasonably foreseeable mis-installation/misuse,
Sharp Metal or Glass Edge in Toys and Other Articles
or changes to the stability of the attachment over time, or
Intended for Use by Children Under 8 Years of Age
combinations thereof. Other hazards may exist (for example,
falls) that are not within the scope of this specification. Such 2.3 Other Standards:
hazards will be the subject of additional standards. IEC 60601-2-52 Medical Electrical Equipment – Part 2-52:
Particular Requirements for the Basic Safety and Essential
1
This specification is under the jurisdiction of ASTM Committee F15 on
3
Consumer Products and is the direct responsibility of Subcommittee F15.70 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Adult Safety Products. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved March 1, 2024. Published March 2024. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2017. Last previous edition approved in 2017 as F3186 – 17. DOI: the ASTM website.
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10.15
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3186 − 17 F3186 − 24
Standard Specification for
1
Adult Portable Bed Rails and Related Products
This standard is issued under the fixed designation F3186; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 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
2
therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC).
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 Units—The 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.
1
This specification is under the jurisdiction of ASTM Committee F15 on Consumer Products and is the direct responsibility of Subcommittee F15.70 on Adult Safety
Products.
Current edition approved Aug. 1, 2017March 1, 2024. Published August 2017March 2024. Originally approved in 2017. Last previous edition approved in 2017 as
F3186 – 17. DOI: 10.1520/F3186-17.10.1520/F3186-24.
2
See “Is The Product a Medical Device?”,Device?,” www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3186 − 24
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
D3359 Test Methods for Rating Adhesion by Tape Test
F1821 Consumer Safety Specification for Toddler Beds
F2085 Consumer Safety Specification for Portable Bed Rails
4
2.2 Federal Standards and Guidelines:
16 CFR 1500.48 Technical Requirements for Determining a Sharp Point in Toys and Other Articles Intended for Use by Children
Under 8 Years of Age
16 CFR 1500.49 Technical Requirements for
...
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