This International Standard specifies requirements and test methods for empty, sterile, disposable syringes, with or without a needle, made of plastic materials and intended exclusively for the injection of insulin with which the syringes are filled by the end user. This International Standard applies to single-use syringes intended for human use and for various insulin concentrations. The insulin syringes specified in this International Standard are intended for immediate use (ie insulin injection) after filling and are not intended to store insulin for an extended period of time. This standard does not apply to disposable glass syringes, syringes for use with syringe pumps, syringes prefilled by the manufacturer and syringes intended for storage after filling (e.g. in a kit intended for filling by a pharmacist).
EN 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
EN ISO 8537:2016 history
2016EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
2008EN ISO 8537:2008 Sterile single-use syringes, with or without needle, for insulin
1994EN ISO 8537:1994 Sterile Single-Use Syringes@ with or Without Needle@ for Insulin (Incorporates Amendment A1: 2000)