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BS 7548(1992) : AMD 8538

BS 7548(1992) : AMD 8538

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SPECIFICATION FOR STERILE, SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN INJECTION

Superseded date

02-15-1995

Published date

11-23-2012

Publisher

British Standards Institution

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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