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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 6-476
Standard
ISO  11608-2:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
Scope/Abstract
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
- needles for dental use;
- pre-attached syringe needles;
- hypodermic needles;
- needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
- materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608 3, and hypodermic needles provided separately are covered in ISO 7864.
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*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, issued April 1993.

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
 Kyran Gibson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Kyran.Gibson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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