EN ISO 8537:2008

Name: EN ISO 8537:2008
Brand: CEN
SKU: EN ISO 8537:2008
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Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007) EN ISO 8537:2008

Publication date: Jul 15, 2010

General information

Current stage: 99.60 Withdrawal effective Apr 13, 2016

Originator: CEN

Owner: CEN/TC 205 Non-active medical devices

Type: European Norm

ICS: 11.040.25 Syringes, needles and catheters

Buying

Status: Withdrawn

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WITHDRAWN
EN ISO 8537:1994

WITHDRAWN
EN ISO 8537:1994/A1:2000

NOW

WITHDRAWN
EN ISO 8537:2008
99.60 Withdrawal effective
Apr 13, 2016

REVISED BY

PUBLISHED
EN ISO 8537:2016