| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
041
|
Date of Entry 04/04/2016
|
|
FR Recognition Number
|
6-357
|
| Standard | |
ISO 10555-6 First edition 2015-04-15
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports |
|
Scope/AbstractISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring 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. |
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Transition Period
| FDA recognition of ISO 10555-6 First edition 2015-04-15 [Rec# 6-357] will be superseded by recognition of ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019] [Rec# 6-490]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-357] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-357] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5965 |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
Class 2
|
LJT
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990
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. |
