ISO 7864:2016
Sterile hypodermic needles for single use - Requirements and test methods

Standard No.

ISO 7864:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO 7864:2016

Scope

This International Standard specifies requirements for Sterile hypodermic needles for Single use of designated metric sizes 0,18 mm to 二2 mm It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

ISO 7864:2016 Referenced Document

• ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
• ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
• ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 6009:1992 Hypodermic needles for single use; colour coding for identification
• ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
• ISO 8362-1:2009 Injection containers and accessories - Part 1: Injection vials made of glass tubing
• ISO 8362-2:2015 Injection containers and accessories - Part 2: Closures for injection vials
• ISO 8362-3:2001 Injection containers and accessories - Part 3: Aluminium caps for injection vials
• ISO 8362-4:2011 Injection containers and accessories - Part 4: Injection vials made of moulded glass
• ISO 8362-5:2016 Injection containers and accessories - Part 5: Freeze drying closures for injection vials
• ISO 8362-6:2010 Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials
• ISO 8362-7:2006 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
• ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
• ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
• ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
• ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization*， 2020-05-14 Update
• ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

ISO 7864:2016 history

• 2016 ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
• 1993 ISO 7864:1993 Sterile hypodermic needles for single use
• 1988 ISO 7864:1988 Sterile hypodermic needles for single use
• 1984 ISO 7864:1984 Sterile hypodermic needles for single use