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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 064 Date of Entry 05/26/2025 
FR Recognition Number 6-511
Standard
ISO  11040-4 Fourth edition 2024-06
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Scope/Abstract
This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

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

This document is applicable to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
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FDA recognition of ISO 11040-4 Third edition 2015-04-01 [Rec# 6-464] will be superseded by recognition of ISO 11040-4 Fourth edition 2024-06 [Rec# 6-511]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-464] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 6-464] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, issued June 2013.

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 Contact
 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.
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