ISO 8537:2007

Sterile single-use syringes, with or without needle, for insulin

Publication date:   Oct 1, 2007

95.99   Withdrawal of Standard   Mar 21, 2016

General information

95.99   Withdrawal of Standard   Mar 21, 2016

ISO

ISO/TC 84 Devices for administration of medicinal products and catheters

International Standard

11.040.25   Syringes, needles and catheters

Buying

  Withdrawn

PDF - €81.07

  English  



Buy

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WITHDRAWN
ISO 8537:1991

WITHDRAWN
ISO 8537:1991/Amd 1:2000

NOW

WITHDRAWN
ISO 8537:2007
95.99 Withdrawal of Standard
Mar 21, 2016

REVISED BY

PUBLISHED
ISO 8537:2016