| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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6-11
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| Standard | |
ISO 594-1 First edition 1986-06-15
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements |
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Scope/Abstract| Specification of the requirements for conical (Luer) fittings for use with hyperdemic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets. It covers fittings made of rigid and semi-rigid materials and includes test methods for gauging and performance. It excludes provision for more flexible or elastomeric materials. The annex on liquid leakage is given as an example. |
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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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Transition Period
| FDA recognition of ISO 594-1 First edition 1986-06-15 [Rec# 6-11] and ISO 594-2 Second edition 1998-09-01 [Rec# 6-129] will be superseded by recognition of ISO 80369-7 Second edition 2021-05 [Rec# 5-133]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-11] and [Rec# 6-129] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-11] and [Rec# 6-129] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5860 |
Syringe, Antistick |
Class 2 |
MEG |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
| §880.5570 |
Needle, Hypodermic, Single Lumen |
Class 2 |
FMI |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles. Issued April 1993
Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes. Issued April 1993
Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features. Issued August 9, 2005
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. |
