Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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8-611
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Standard | |
ISO 9584 Second edition 2023-10 Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants |
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Scope/AbstractThis International Standard establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments. The procedures established in this document apply to film-based methods. The recommendations on the acceptance limits for internal imperfections in cast metallic surgical implants are given in Annex A.
NOTE In this document, when not otherwise specified, the term "manufacturer" refers to the "implant manufacturer", and the term "product" refers to the "metallic cast implant for surgery" or to the "component of metallic cast implant for surgery".
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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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Transition Period
FDA recognition of ISO 9584 First edition 1993-10-15 [Rec# 8-159] will be superseded by recognition of ISO 9584 Second edition 2023-10 [Rec# 8-611]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-159] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 8-159] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
21 CFR 888.3XXX Metallic components of all implantables |
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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. |
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FDA Technical Contact
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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. |