• 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 054 Date of Entry 07/06/2020 
FR Recognition Number 6-441
Standard
ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
Scope/Abstract
ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.
ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.
ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.
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.
Transition Period
FDA recognition of ISO 7886-3 First edition 2005-03-01 [Rec# 6-148] will be superseded by recognition of ISO 7886-3 Second edition 2020-05 [Rec# 6-441]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-148] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 6-148] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
FDA Technical Contacts
 Michael Simpson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-4070
  Michael.Simpson@fda.hhs.gov
 Rong Guo
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  240-402-6290
  Rong.Guo@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
*These are provided as examples and others may be applicable.
-
-