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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 6-365
Standard
ISO 11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for injectables
Scope/Abstract
This part of ISO 11040 applies to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of ISO 11040 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040.
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FDA recognition of ISO 11040-4 Third edition 2015-04-01 [Rec# 6-365] will be superseded by recognition of ISO 11040-4 Third edition 2015-04-01 [Including AMENDMENT 1 (2020)] [Rec# 6-464]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-365] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 6-365] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5860 Injector, Pen Class 2 NSC
§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 Contact
 Kyran Gibson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Kyran.Gibson@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.
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