Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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6-179
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Standard | |
ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods |
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Scope/AbstractISO 21649:2006 applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a "cartridge", "ampoule", "syringe", "capsule" or "disc". In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.5430 |
Injector, Fluid, Non-Electrically Powered
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Class 2
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KZE
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |