ISO 11040-4 Third edition 2015-04-01

Standard Organization:

ISO 11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for injectables

Recognition Date2016-06-27
Recognition List043
Recognition Number6-365
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG General Plastic Surgery/General Hospital
FDA Tech  Mary Brooks   FDA/OMPT/CDRH/ODE/DAGID/GHDB/   301-796-6078   Mary.Brooks@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 11040-4:2015 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.

ISO 11040-4:2015 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 ISO 11040-4:2015 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040 4:2015.

Code of Federal Regulations:

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 Guidance:

FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, Issued April 1993.


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