Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 6-480
Standard
ISO  11608-6:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
Scope/Abstract
This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
NOTE 1 Although technically a device using a soft cannula is not "needle-based", the soft cannula is placed by a needle and can be included in this classification.
NOTE 2 Some requirements and methods are already established and included in other parts of the ISO 11608 series.
Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them.
NOTE 3 They are covered by IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5860 On-Body Injector Class 2 QLF
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.
-
-