UNE-EN ISO 8537:2016
Current
The latest, up-to-date edition.
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Hardcopy , PDF
Spanish, Castilian, English
16-11-2016
Committees responsible
National foreword
Introduction
Specification
1. Scope
2. Normative references
3. Definitions and nomenclature
4. Types of syringe
5. Freedom from extraneous matter
6. Limits for extractable matter
7. Lubrication of syringes and needles
8. Range of sizes
9. Graduated scale
10. Barrel
11. Piston/plunger assembly
12. Nozzle
13. Needles
14. Performance of assembled syringe
15. Packaging
16. Marking
Annexes
A. Fluid for determination of acidity/alkalinity and
extractable metals
B. Test method for air leakage past syringe piston
during aspiration
C. Test method for force required to operate plunger
D. Properties of needles with external diameter less
than 0,45 mm
E. Test method for determination of dead space
F. Test method for liquid leakage at syringe piston
and syringe nozzle/hub or needle/barrel unions
during compression
G. Test method for air leakage past nozzle/hub or
needle/barrel unions during aspiration
H. Preparation of extract for test for pyrogenicity
and toxicity
J. Symbol for 'do not re-use'
Tables
1. Insulin syringes, range of sizes, graduated scale
and tolerance on graduated capacity
2. Maximum dead space
D.1 Diameter of needle tube
D.2 Stiffness
D.3 Minimum strength of bond between hub/syringe and
needle tube
D.4 Size of stylet to test patency of lumen
D.5 Resistance to breakage
Figures
1. Schematic representation of insulin syringe for
single use
B.1 Apparatus used in aspiration tests
J.1 ISO symbol for single use, number ISO 7000/1051
This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. The Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.This Standard excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE 53372. (09/2003)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 8537:2016 | Identical |
| BS EN ISO 8537:2016 | Identical |
| NBN EN ISO 8537 : 2016 | Identical |
| ISO 8537:2016 | Identical |
| NF EN ISO 8537 : 2016 | Identical |
| I.S. EN ISO 8537:2016 | Identical |
| NS EN ISO 8537 : 1994 | Identical |
| DIN EN ISO 8537:2001-03 | Identical |
| DIN EN ISO 8537:2008-10 | Identical |
| NEN EN ISO 8537 : 2016 | Identical |
| NF EN ISO 80369-7 : 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 11608-5:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 81714-1:2010 | Design of graphical symbols for use in the technical documentation of products — Part 1: Basic rules |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
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