ISO 594-1 First edition 1986-06-15

Standard Organization:

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

Recognition Date2016-12-23
Recognition List046
Recognition Number6-11
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG General Plastic Surgery/General Hospital
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

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

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