BS 5081-1:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Sterile hypodermic syringes and needles Specification for sterile, single-use hypodermic syringes for manual use
Hardcopy , PDF
15-09-1997
English
15-01-1994
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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Superseded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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