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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 051 Date of Entry 01/14/2019 
FR Recognition Number 11-184
Standard
ISO  8827 First edition 1988-10-15
Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
Scope/Abstract
This International Standard covers general requirements and the designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery.

NOTE - The annex gives guidance on the selection and use of staples and does not form an integral part of this International Standard.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 8 Packaging
Clause 9 Marking of packages

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:
Clauses 8 and 9 refer to ISO 6018:1987 Orthopaedic implants - General requirements for marking, packaging, and labeling, which is withdrawn. See ISO 11607-1 & 2 below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3030 Staple, Fixation, Bone Class 2 JDR
Relevant FDA Guidance and/or Supportive Publications*
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.

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 Contact
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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