BS 7548(1992) : AMD 8538
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SPECIFICATION FOR STERILE, SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN INJECTION
02-15-1995
11-23-2012
Committees responsible
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. BS AMD 8538 RENUMBERS THIS STANDARD TO BS EN ISO 8537: 1995
| DevelopmentNote |
Renumbered and superseded by BS EN ISO 8537 BS AMD 8538 is available free of charge. See separate amendment record Supersedes 87/54650 DC (04/2005)
|
| DocumentType |
Standard
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 8537:2016 | Identical |
| BS 5081-2(1993) : 1993 AMD 9104 | STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| BS 3930-1(1987) : AMD 8072 | CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND OTHER MEDICAL EQUIPMENT - SPECIFICATION FOR GENERAL REQUIREMENTS |
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