Plunger Rod for Syringe - Is there a standard for piston rods?

#1
Hi,

I would like to know if there is a standard for syringe plunger rods. I know ISO 11040 but I can not find anything on the piston rods.

Thank you.

Jojo.
 
#2
So assuming you are interested in what FDA requires for the manufacture of piston syringes, it's helpful to start with the regulation.
21 CFR §880.5860 Syringe, Piston, Product Code FMF.

There is also a Recognized Consensus Standard page describing the requirements and a transition that affects syringes:
Part B: Supplementary Information Sheet (SIS), FR Recognition List Number 046, FR Recognition Number 5-11, Date of Recognition 12/23/2016
Transition Period FDA recognition of ISO 594-1:1986 [Rec# 6-11] and ISO 594-2:1998 [6-129] is hereby superseded by recognition of ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications [Rec# 5-115]. FDA will accept declaration of conformity, in support of premarket submissions, to [Rec# 6-11] and [6-129] until December 31, 2019. After this transitional period, declaration of conformity to [Rec# 6-11] and [6-129] will not be accepted.

The page also lists three guidances and a website, along with Technical Contacts at FDA.

It seems I am not yet allowed to post web links (haven't contributed enough?) so you will have to navigate to those resources on the FDA site.

Christine
 
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