DIN EN ISO 8537:2008
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007); English version of DIN EN ISO 8537:2008-10

Standard No.

DIN EN ISO 8537:2008

Release Date

2008

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 8537:2016

DIN EN ISO 8537 E:2014

Latest

DIN EN ISO 8537:2016-11

Replace

DIN EN ISO 8537:2001

Scope

This International Standard specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-IO0). Sterile syringes specified in this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

DIN EN ISO 8537:2008 Referenced Document

• ISO 7864:1993 Sterile hypodermic needles for single use
• ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods*， 2016-08-01 Update

DIN EN ISO 8537:2008 history

• 2016 DIN EN ISO 8537:2016-11 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016); German version EN ISO 8537:2016
• 2016 DIN EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016); German version EN ISO 8537:2016
• 2008 DIN EN ISO 8537:2008 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007); English version of DIN EN ISO 8537:2008-10
• 0000 DIN EN ISO 8537:2001