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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 055 Date of Entry 12/21/2020 
FR Recognition Number 6-449
ASTM  F1169-19
Standard Consumer Safety Specification for Full-Size Baby Cribs
1.1 This consumer safety specification establishes performance requirements and test procedures to determine the structural integrity of full- cribs. It also contains design requirements addressing entanglement on crib corner post extensions, and requirements for warning labels and instructional material. It also covers bassinet, changing table, or similar accessories to a crib that when in the manufacturer's recommended use position are in the occupant retention area. These accessories shall also comply with the applicable requirements of the ASTM International standards addressing those accessories. For example, a changing table that attaches to a crib shall also comply with the applicable requirements in Consumer Safety Specification F2388. This specification does not cover inflatable products.
1.2 No crib produced after the approval date of this consumer safety specification shall, either by label or other means, indicate compliance with this specification unless it conforms to all requirements contained herein.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 4. Calibration and Standardization.
General Requirements - Clause 5.8 Spacing of Crib Components.
General Requirements - Clause 5.10 Hardware and Fasteners.
General Requirements - Clause 5.17 Scissoring, Shearing, or Pinching.
Performance Requirements - Clause 6.2 Cycle Testing.
Performance Requirements - Clause 6.3 Crib Side Latch Test Requirements.
Performance Requirements - Clause 6.6 Crib Side Test Requirements.
Performance Requirements - Clause 6.7 Spindle/Slat Strength Testing.
Performance Requirements - Clause 6.10 Mattress Support System Openings.
Test Methods - Clause 7.3 Crib Side Latch Test.
Test Methods - Clause 7.4 Mattress Support System Vertical Impact Test.
Test Methods - Clause 7.5 Mattress Support System Test.
Test Methods - Clause 7.6 Crib Side Test.
Test Methods - Clause 7.7 Spindle/Slat Static Load Strength Test.
Test Methods - Clause 7.8 Component Spacing Test Method.
Test Methods - Clause 7.11 Openings.
Test Methods - Clause 7.12 Locking Mechanism Test.
Markings and Labeling - Clause 8.1.2.
Markings and Labeling - Clause
Markings and Labeling - Clause
Markings and Labeling - Clause 8.1.4.
Markings and Labeling - Clause 8.2.
Markings and Labeling - Clause 8.3.
Markings and Labeling - Clause Fall Hazard.
Markings and Labeling - Clause
Instructional Literature - 9.1.
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.

This standard is recognized in part because the clauses listed above are inconsistent with an existing regulation, 21 CFR §880.5140 Pediatric medical crib.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5140 Bed, Pediatric Open Hospital Class 2 FMS
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 Contacts
 Matthew Schwerin
 Kyran Gibson
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.