Product Classification

• Device: syringe, piston
• Regulation Description: Piston syringe.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FMF
• Submission Type: 510(k)
• Regulation Number: 880.5860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 595-1 First edition 1986-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions
• ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests
• ISO 7886-3 First edition 2005-03-01 Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization
• ISO 7886-1 First edition 1993-10-01 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
• ISO 8537 Second edition 2007-10-01 Sterile single-use syringes, with or without needle, for insulin
• ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-01 Sterile hypodermic syringes for singe-use - Part 1: Syringes for manual use
• ISO 26825 First edition 2008-08-15 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
• ISO 11608-1 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
• ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• ISO 11040-4 Second edition 2007-02-01 Prefilled syringes - Part 4: Glass barrels for injectables
• ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
• ISO 7886-2 First edition 1996-05-15 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
• ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 11608-4:2006 Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
• ISO 11608-3 First edition 2000-12-15 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods

Guidance Document

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.