| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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6-439
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| Standard | |
ISO 7886-2 Second edition 2020-04
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
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Scope/AbstractThis document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 11 Syringe dimensions
Clause 16 Information supplied by the manufacturer
Subclause 16.3 Unit packaging
Subclause 16.4.1 General
Subclause 16.4.2 Multiple unit packs with self-contained syringes
Subclause 16.5 User packaging
Subclause 16.6 Storage container |
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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.
This standard is recognized in part because:
Clause 11 - Figure 1 and Table 1 are missing or inadequately prescribing acceptable critical dimensions and/or tolerances to support the claim "Suitable for use with power-driven syringe pumps" in Clause 16. Inadequate detection and fluid delivery performance may result in delayed therapy or improper dosing (see References 1 & 2 below).
Clause 16 - The excluded subclauses (16.3, 16.4.1, 16.4.2, 16.5, and 16.6) all state that the packaging and/or container "shall be marked with the following information: 'Suitable for use with power-driven syringe pumps'"; however, syringes that meet this standard have resulted in delayed therapy or inadequate dosing due to a lack of dimensional and/or performance-related design controls (see Reference 1 & 2 below). The statement "Suitable for use with power-driven syringe pumps" is dependent on all relevant syringe design features being adequately specified, tested, and controlled. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5725 |
Pump, Infusion
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Class 2
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FRN
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| §880.5860 |
Syringe, Piston
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Class 2
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FMF
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Relevant FDA Guidance and/or Supportive Publications*
1) FDA Recall, Class I: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/cardinal-health-recalls-sterile-monoject-luer-lock-and-enteral-syringes-due-change-manufacturing, March 7, 2024.
2) FDA Recall, Class I: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=212551, Dec 19, 2023.
3) FDA Safety Communication: https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-cardinal-health-monoject-luer-lock-and-enteral-syringes-fda-safety-communication, February 2, 2024.
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 Contacts
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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. |
