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
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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
Describes requirements and test methods for sterile syringes with or without needles for single use solely for the injection of insulin in humans. Covers syringes for use with 40 units of insulin/ml and 100 units of insulin/ml. Intended for use soon after filling as they are not suitable for containing insulin over extended periods of time. Covers normative references, definitions and nomenclature, types of syringe, freedom from extraneous matter, limits for extractable matter, lubrication of syringes and needles, range of sizes, graduated scale, barrel, piston/plunger assembly, nozzle, needles, performance of assembled syringe packaging and marking.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE 53372. (09/2003)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8537:2001-03 | Identical |
| ISO 8537:2016 | Identical |
| NBN EN ISO 8537 : 2016 | Identical |
| NEN EN ISO 8537 : 2016 | Identical |
| NS EN ISO 8537 : 1994 | Identical |
| I.S. EN ISO 8537:2016 | Identical |
| SN EN ISO 8537 : 2016 | Identical |
| UNI EN ISO 8537 : 2008 | Identical |
| BS EN ISO 8537:2016 | Identical |
| EN ISO 8537:2016 | Identical |
| NF EN ISO 8537 : 2016 | Identical |
| DIN EN ISO 8537:2008-10 | 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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