Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020

FR Recognition Number

6-439

Standard

ISO 7886-2 Second edition 2020-04
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps

Scope/Abstract

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

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.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§880.5725	Pump, Infusion	Class 2	FRN
§880.5860	Syringe, Piston	Class 2	FMF

Relevant FDA Guidance and/or Supportive Publications*

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 Contacts

Rong Guo

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

240-402-6290

Rong.Guo@fda.hhs.gov

Gang Peng

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

301-348-1960

Gang.Peng@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization