| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
045
|
Date of Entry 09/21/2016
|
|
FR Recognition Number
|
6-379
|
| Standard | |
ISO 7864 Fourth edition 2016-08-01
Sterile hypodermic needles for single use - Requirements and test methods |
|
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. |
|
| Extent of Recognition
|
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. |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
