ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin

Standard No.

ISO 8537:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO 8537:2016

ISO 8537:2016 Referenced Document

• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11608-1:2014 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
• ISO 23908:2011 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 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 7864:1993 Sterile hypodermic needles for single use
• ISO 81714-1:2010 Design of graphical symbols for use in the technical documentation of products - Part 1: Basic rules
• ISO 9626:1991 Stainless steel needle tubing for manufacture of medical devices

ISO 8537:2016 history

• 2016 ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
• 2007 ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin
• 2000 ISO 8537:1991/Amd 1:2000 Sterile single-use syringes, with or without needle, for insulin, Amendment 1
• 1991 ISO 8537:1991 Sterile single-use syringes, with or without needle, for insulin