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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 6-271
Standard
ASTM F1874-98 (Reapproved 2011)
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
Scope/Abstract
1.1 This test method describes the procedure for bend testing needles used for the placement of surgical sutures.
1.2 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 and health practices and determine the applicability of regulatory limitations prior to use.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4800 Needle, Suturing, Disposable Class 1 GAB
§878.4800 Needle, Suturing, Reusable Class 1 GDL
§882.4650 Needle, Neurosurgical Suture Class 1 HAS
FDA Technical Contact
 Long Chen
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA/
  301-796-6389
  long.chen@fda.hhs.gov
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.
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