Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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8-112
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Standard | |
ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
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Scope/Abstract1.1 This test method covers shear testing of continuous calcium phosphate coatings and metallic coatings adhering to dense metal substrates at ambient temperatures. It assesses the degree of adhesion of coatings to substrates, or the internal cohesion of a coating in shear, parallel to the surface plane. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. |
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Extent of Recognition
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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. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, Issued April 1994.
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, Issued March 1995 (revised 2/20/97).
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, Issued May 2004.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |