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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 043 Date of Entry 06/27/2016 
FR Recognition Number 6-377
Standard
ISO 11608-5 First edition 2012-10-01
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
Scope/Abstract
ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.
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FDA recognition of ISO 11608-5 First edition 2012-10-01 Rec# 6-377 will be superseded by recognition of of ISO 11608-5:2022 Rec# 6-479.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*
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Draft Guidance for Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO)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.

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
 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 Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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