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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.
Transition Period
FDA recognition of ISO 11608-5 First edition 2012-10-01 Rec# 6-377 will be superseded by recognition of of ISO 11608-5:2022 Rec# 6-479. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-377 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-377 will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
§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.

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.
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