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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 6-341
Standard
ISO 11608-1 Third edition 2014-12-15
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
Scope/Abstract
ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-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FDA recognition of ISO 11608-1 Third edition 2014-12-15 Rec# 6-341 will be superseded by recognition of of ISO 11608-1:2022 Rec# 6-478. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-341 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-341 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*
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993

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

Draft Guidance for Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4. Issued April 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
 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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