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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 11-184: ISO 8827 First edition 1988-10-15, implants for surgery - staples with parallel legs for orthopaedic use - general requirements. (Orthopaedics)

Date of Standard: 1988. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Metallic bone staples with parallel legs intended for use in orthopaedic surgery
Processes Affected:
510(k), HDE, IDE, PDP, PMA, Design Controls
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard with the exception of the sections that refer to ISO 6018 which has been withdrawn.

This standard discusses specifications for metallic bone staples with parallel legs intended for use in orthopaedic surgery including considerations related to design, size, tolerances, and materials. ASTM F564-02 can be referenced for information on test setups and methods for the characterization of metallic bone staples. Additional information should be provided to document deviations from the standard as well as to document that the design of the product will provide adequate mechanical properties for the particular application. Of note, the packaging and marking of packages section of this standard refer to ISO 6018 which has been withdrawn.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§888.3030 Staple, Fixation, Bone Class 2 JDR
FDA Technical Contact:
 Jonathan Peck
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  301/796-5650
  email: jonathan.peck@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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