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Norm

ÖNORM EN ISO 8537

Issue date: 2008 09 01

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

This International Standard specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are ...
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Withdrawn : 2016 10 15
Publisher:
Austrian Standards International
Format:
Digital | 28 Pages
Language:
German | English | Download GER/ENG
Currently valid:
ÖNORM EN ISO 8537:2016 10 15
Optionally co-design standards:
Committee 179: Medical technology
ICS
11.040.25
Topics
Healthcare, Medical equipment, Syringes, needles and catheters
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-100). 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.
ÖNORM EN ISO 8537
2016 10 15
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Norm
ÖNORM EN ISO 8537
2008 09 01
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Norm
↖
ÖNORM EN ISO 8537/A1
2001 02 01
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:1991/DAM 1:2000)
Norm
ÖNORM EN ISO 8537
1995 04 01
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:1991)
Norm
Historie aufklappen
Norm
ISO 9626:1991
Issue date : 1991 08 22
Stainless steel needle tubing for the manufacture of medical devices
Norm
ISO 594-1:1986
Issue date : 1986 06 12
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
Norm
ISO 7864:1993
Issue date : 1993 05 06
Sterile hypodermic needles for single use
Norm
ISO 9626:2016
Issue date : 2016 08 02
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
Norm
ÖNORM EN ISO 8537
Issue date : 2016 10 15
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Norm
ISO 8537:2007
Issue date : 2007 10 01
Sterile single-use syringes, with or without needle, for insulin