Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

030

Date of Entry 01/15/2013

FR Recognition Number

6-148

Standard

ISO 7886-3 First edition 2005-03-01 Sterile hypodermic syringes for single use -- Part 3: Auto-disable 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FDA recognition of ISO 7886-3 First edition 2005-03-01 [Rec# 6-148] will be superseded by recognition of ISO 7886-3 Second edition 2020-05 [Rec# 6-441].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