• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 6-275
Standard
ISO 11608-2 Second edition 2012-04-01
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
Scope/Abstract
ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
Extent of Recognition
Complete standard
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
§880.6920 Introducer, Syringe Needle Class 2 KZH
§880.5860 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
Relevant FDA Guidance and/or Supportive Publications
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993
FDA Technical Contacts
 Oleg Vesnovsky
  FDA/OMPT/CDRH/OSEL/DAM/
  301-796-2527
  oleg.vesnovsky@fda.hhs.gov
 Mary Brooks
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-6078
  Mary.Brooks@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
-
-