| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
043
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Date of Entry 06/27/2016
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|
FR Recognition Number
|
6-364
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| Standard | |
ISO 8537 Third edition 2016-03-15
Sterile single-use syringes, with or without needle, for insulin |
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Scope/AbstractISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist). |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Section 5.3 Colour coding. |
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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:
Section 5.3 is not consistent with an existing published final guidance, see Section II, D, Device Description of the guidance listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5570 |
Needle, Hypodermic, Single Lumen
|
Class 2
|
FMI
|
| §880.5860 |
Syringe, Piston
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Class 2
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FMF
|
|
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 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. |
