| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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045
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Date of Entry 09/21/2016
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FR Recognition Number
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6-379
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| Standard | |
ISO 7864 Fourth edition 2016-08-01
Sterile hypodermic needles for single use - Requirements and test methods |
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Scope/AbstractISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric s 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen needles. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5570 |
Needle, Hypodermic, Single Lumen |
Class 2 |
FMI |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles. Issued April 1993.
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)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
