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ILNAS-EN ISO 8537:2008 Edition 07/2008
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project      date of ratification (dor)    15/06/2008
end of the vote on the project      date of anouncement (doa)    31/10/2008
start of the vote on the final project    14/02/2008   date of publication (dop)    31/01/2009
end of the vote on the final project    14/05/2008   date of withdrawal (dow)    31/01/2009


Publication Official Journal
of the Grand-Duchy of Luxembourg
11/05/2011
Reference

Relations

Evolutions
ILNAS-EN ISO 8537:2016

Relations to older standards
ILNAS-EN ISO 8537:1994/A1:2000
ILNAS-EN ISO 8537:1994

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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