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SSH EN ISO 8537:2008

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)

Oct 10, 2008
95.99 Withdrawal of Standard   Apr 25, 2017

General information

95.99     Apr 25, 2017

DPS

DPS/KT 205

European Norm

11.040.25  

English  

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Scope

ISO 8537:2007 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-100).
Sterile syringes specified in ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 8537:1994

WITHDRAWN
SSH EN ISO 8537:1994/A1:2000

NOW

WITHDRAWN
SSH EN ISO 8537:2008
95.99 Withdrawal of Standard
Apr 25, 2017

REVISED BY

PUBLISHED
SSH EN ISO 8537:2016

Related project

Adopted from EN ISO 8537:2008