ASTM F3186-17
(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).
This specification also covers test set-up requirements, test equipment, test requirements and methods, labels and warnings requirements, permanency of labels and warnings, and product instructions.
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...
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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 −17
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 indicate compliance with this specification unless it conforms
to all the requirements contained herein.
1.1 This safety specification establishes performance re-
quirements for adult portable bed rails, related products, and 1.7 Units—The values stated in inch-pound units are to be
adult portable bedrail accessories, including requirements for regarded as standard. The values given in parentheses are
resistance to entrapment, marking and adhered labels, instruc- mathematical conversion to SI units that are provided for
tional literature, and advertising. information only and are not considered standard.
1.8 This standard does not purport to address all of the
1.2 This standard is applicable to any such product (as
safety concerns, if any, associated with its use. It is the
definedbelow)thatisnotdesignedaspartofthebedbythebed
responsibility of the user of this standard to establish appro-
manufacturer,andisinstalledon,againstoradjacenttotheside
priate safety, health and environmental practices and deter-
of an adult bed and is for use by adults to reduce the risk of
mine the applicability of regulatory limitations prior to use.
falling from the bed, assist in repositioning in the bed, assist in
1.9 This international standard was developed in accor-
transitioning into or out of the bed, or other similar purposes as
dance with internationally recognized principles on standard-
stated by the manufacturer.
ization established in the Decision on Principles for the
1.3 This safety specification includes adult portable bed
Development of International Standards, Guides and Recom-
rails that meet the definition of a medical device and are
mendations issued by the World Trade Organization Technical
therefore under the jurisdiction of the Food and Drug Admin-
Barriers to Trade (TBT) Committee.
istration (FDA), and adult portable bed rails that are not
medicaldevices,andwhichthereforefallunderthejurisdiction
2. Referenced Documents
2
of the Consumer Product Safety Commission (CPSC).
3
2.1 ASTM Standards:
1.4 This safety specification does not cover guardrails or
D3359 Test Methods for Rating Adhesion by Tape Test
side rails intended for use on FDA regulated hospital beds, or
F1821 Consumer Safety Specification for Toddler Beds
portable rails for children which are included in Consumer
F2085 ConsumerSafetySpecificationforPortableBedRails
Safety Specification F1821 for toddler beds, Consumer Safety 4
2.2 Federal Standards and Guidelines:
Specification F2085 for portable bed rails for children, or IEC
16 CFR 1500.48 Technical Requirements for Determining a
60601-2-52 for medical beds.
Sharp Point in Toys and Other Articles Intended for Use
1.5 This safety specification is intended to minimize entrap- by Children Under 8 Years of Age
ment and strangulation hazards that are attributed to design 16 CFR 1500.49 Technical Requirements for Determining a
components, whether these hazards arise from normal instal- Sharp Metal or Glass Edge in Toys and Other Articles
lation and use, reasonably foreseeable mis-installation/misuse, Intended for Use by Children Under 8 Years of Age
or changes to the stability of the attachment over time, or 2.3 Other Standards:
combinations thereof. Other hazards may exist (for example,
IEC 60601-2-52 Medical Electrical Equipment – Part 2-52:
falls) that are not within the scope of this specification. Such ParticularRequirementsfortheBasicSafetyandEssential
5
hazards will be the subject of additional standards.
Performance of Medical Beds
1.6 No adult portable bed rail, or related product as defined
in this specification, shall, either by label or other means, 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This specification is under the jurisdiction of ASTM Committee F15 on the ASTM website.
4
Consumer Products and is the direct responsibility of Subcommittee F15.70 on Available from U.S. Government Printing Office, Superintendent of
Adult Safety Products. Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
Current edition approved Aug. 1, 2017
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3186 − 17
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 indicate compliance with this specification unless it conforms
to all the requirements contained herein.
1.1 This safety specification establishes performance re-
quirements for adult portable bed rails, related products, and 1.7 Units—The values stated in inch-pound units are to be
adult portable bedrail accessories, including requirements for regarded as standard. The values given in parentheses are
resistance to entrapment, marking and adhered labels, instruc- mathematical conversion to SI units that are provided for
tional literature, and advertising. information only and are not considered standard.
1.8 This standard does not purport to address all of the
1.2 This standard is applicable to any such product (as
safety concerns, if any, associated with its use. It is the
defined below) that is not designed as part of the bed by the bed
responsibility of the user of this standard to establish appro-
manufacturer, and is installed on, against or adjacent to the side
priate safety, health and environmental practices and deter-
of an adult bed and is for use by adults to reduce the risk of
mine the applicability of regulatory limitations prior to use.
falling from the bed, assist in repositioning in the bed, assist in
1.9 This international standard was developed in accor-
transitioning into or out of the bed, or other similar purposes as
dance with internationally recognized principles on standard-
stated by the manufacturer.
ization established in the Decision on Principles for the
1.3 This safety specification includes adult portable bed
Development of International Standards, Guides and Recom-
rails that meet the definition of a medical device and are
mendations issued by the World Trade Organization Technical
therefore under the jurisdiction of the Food and Drug Admin-
Barriers to Trade (TBT) Committee.
istration (FDA), and adult portable bed rails that are not
medical devices, and which therefore fall under the jurisdiction
2. Referenced Documents
2
of the Consumer Product Safety Commission (CPSC).
3
2.1 ASTM Standards:
1.4 This safety specification does not cover guardrails or
D3359 Test Methods for Rating Adhesion by Tape Test
side rails intended for use on FDA regulated hospital beds, or
F1821 Consumer Safety Specification for Toddler Beds
portable rails for children which are included in Consumer
F2085 Consumer Safety Specification for Portable Bed Rails
Safety Specification F1821 for toddler beds, Consumer Safety 4
2.2 Federal Standards and Guidelines:
Specification F2085 for portable bed rails for children, or IEC
16 CFR 1500.48 Technical Requirements for Determining a
60601-2-52 for medical beds.
Sharp Point in Toys and Other Articles Intended for Use
1.5 This safety specification is intended to minimize entrap- by Children Under 8 Years of Age
ment and strangulation hazards that are attributed to design 16 CFR 1500.49 Technical Requirements for Determining a
components, whether these hazards arise from normal instal- Sharp Metal or Glass Edge in Toys and Other Articles
lation and use, reasonably foreseeable mis-installation/misuse, Intended for Use by Children Under 8 Years of Age
or changes to the stability of the attachment over time, or
2.3 Other Standards:
combinations thereof. Other hazards may exist (for example, IEC 60601-2-52 Medical Electrical Equipment – Part 2-52:
falls) that are not within the scope of this specification. Such
Particular Requirements for the Basic Safety and Essential
5
hazards will be the subject of additional standards. Performance of Medical Beds
1.6 No adult portable bed rail, or related product as defined
3
in this specification, shall, either by label or other means,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This specification is under the jurisdiction of ASTM Committee F15 on the ASTM website.
4
Consumer Products and is the direct responsibility of Subcommittee F15.70 on Available from U.S. Government Printing Office, Superintendent of
Adult Safety Products. Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
Current edition approved Aug. 1, 2017. Published August 2017. DOI: 10.1520/ www.access.gpo.gov.
5
F3186-17. Available from Internat
...
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