Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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6-477
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Standard | |
ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
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Scope/AbstractThis document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: - sterile hypodermic needles; - sterile hypodermic syringes; - sterile single-use syringes, with or without needle, for insulin; - containers that can be refilled multiple times; - containers intended for dental use; - catheters or infusion sets that are attached or assembled separately by the user. |
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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)*
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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 - Container Closure Systems for Packaging Human Drugs and Biologics, issued May 1999.
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. |