Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

058

Date of Entry 05/30/2022 

FR Recognition Number

6-479

Standard

ISO  11608-5:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions

Scope/Abstract

This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).
General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) recording of device functions;
NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.

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
§880.5860	Syringe, Piston	Class 2	FMF
§880.5860	Syringe, Antistick	Class 2	MEG
§880.5860	Syringe, Piston, Reprocessed	Class 2	NKN
§880.5860	Injector, Pen	Class 2	NSC
§880.6920	Introducer, Syringe Needle	Class 2	KZH

Relevant FDA Guidance and/or Supportive Publications*

1. Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, issued April 1993.
2. Guidance for Industry and FDA Staff: Technical Consideration 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

 Alan Stevens

  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

  301-796-6294

  Alan.Stevens@fda.hhs.gov

Standards Development Organization

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Groups (STG)

General Plastic Surgery/General Hospital (primary)

Radiology

*These are provided as examples and others may be applicable.