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BS 5081-1:1994

BS 5081-1:1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterile hypodermic syringes and needles Specification for sterile, single-use hypodermic syringes for manual use

Available format(s)

Hardcopy , PDF

Superseded date

09-15-1997

Language(s)

English

Published date

01-15-1994

Publisher

British Standards Institution

Committees responsible
National foreword
Introduction
Specification
1. Scope
2. Normative references
3. Definitions
4. Nomenclature
5. Cleanliness
6. Limits for acidity or alkalinity
7. Limits for extractable metals
8. Lubricant
9. Tolerance on graduated capacity
10. Graduated scale
11. Barrel
12. Piston/plunger assembly
13. Nozzle
14. Performance
15. Packaging
16. Labelling
Annexes
A. Method for preparation of extracts
B. Test method for air leakage past syringe piston
    during aspiration, and for separation of piston
    and plunger
C. Method for determination of dead space
D. Test method for liquid leakage at syringe piston
    under compression
E. Guidance on materials
F. Examples of test methods for incompatibility
    between syringes and injection fluids
G. Test method for forces required to operate plunger
H. Symbol for "do not re-use"
J. Bibliography
Tables
1. Capcity tolerance, dead space, scale dimensions and
    test forces
F.1 Matrix of compatibility tests
G.1 Proposed values for forces required to operate
    plunger
Figures
1. Schematic representation of hypodermic syringe for
    single use
2. Examples of scale graduations
B.1 Apparatus for aspiration test
G.1 Apparatus for determining forces to operate plunger
G.2 Examples of graph of forces required to operate
    plunger
H.1 ISO symbol for "do not re-use", number ISO 7000/1051

Specifies requirements for sterile single-use hypodermic syringes made of plastics materials and meant for the aspiration of fluids or for the injection of fluids immediately after filling. Coverage includes definitions, nomenclature, lubricant, cleanliness, barrel, packaging, labelling, nozzle and tolerance on graduated capacity. Also includes detailed diagrams, tables and annexes.

Committee
CH/84
DevelopmentNote
Supersedes 91/53633 DC (06/2005)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 7886-1:2017 Identical

ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

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Hardcopy - English
PDF - English
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