AS 1094-1993

1 - AS 1094-1993 MEDICAL EQUIPMENT - SINGLE-USE SYRINGES (STERILE) FOR GENERAL MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE
6 - 2 REFERENCED DOCUMENTS
7 - 3 DEFINITIONS
7 - 3.1 Dead space
7 - 3.2 Multiple pack
7 - 3.3 Nominal capacity
7 - 3.4 Non-reusable
7 - 3.5 Syringe
7 - 3.6 Unit
7 - 3.7 Unit pack
7 - 4 DESCRIPTION AND DIMENSIONS OF SYRINGE
7 - 4.1 Description
8 - 4.2 Dimensions
8 - 4.2.1 Length
8 - 4.2.2 Length of projection of plunger from barrel
8 - 5 REQUIREMENTS FOR BARREL
8 - 5.1 Composition
8 - 5.2 Shape
8 - 5.3 Lumen
8 - 5.4 Flange (finger grip)
9 - 5.5 Nozzle
9 - 5.6 Scale
9 - 5.6.1 General
11 - 5.6.2 Length
11 - 5.6.3 Pigmentation
11 - 5.6.4 Intervals
11 - 5.6.5 Graduation lines
12 - 5.6.6 Numbering and wording
12 - 5.6.7 Durability
14 - 5.6.8 Precision
14 - 6 REQUIREMENTS FOR PLUNGER
14 - 6.1 Composition
14 - 6.2 Lubricant
14 - 6.3 Push-button
14 - 6.4 Rigidity
14 - 6.5 Seal
14 - 6.6 Fiducial line
14 - 6.7 Contamination of fluid pathway
14 - 7 FIT OF PLUNGER IN BARREL
14 - 7.1 Under pressure
14 - 7.2 Under suction
15 - 7.3 Plunger movement
15 - 8 RESISTANCE TO HEAT
15 - 9 REQUIREMENTS FOR NEEDLE
15 - 10 CONNECTION BETWEEN NEEDLE HUB AND NOZZLE
15 - 11 DEAD SPACE
16 - 12 PARTICULATE CONTAMINATION
16 - 13 REDUCING (OXIDIZABLE) MATTER
16 - 14 EXTRACTABLE TRACE METALS
16 - 15 NON-VOLATILE RESIDUE
16 - 16 ETHYLENE OXIDE AND ETHYLENE GLYCOL RESIDUES
16 - 17 PYROGENICITY
16 - 18 CYTOTOXICITY
16 - 19 STERILITY
17 - 20 HAEMOLYTIC EFFECTS
17 - 21 INTRACUTANEOUS REACTIVITY
17 - 22 INCOMPATIBILITY WITH INJECTABLE SUBSTANCES
17 - 23 PACKAGING
17 - 23.1 Sheath
17 - 23.2 Unit pack
17 - 23.3 Multiple pack
17 - 24 MARKING
18 - 24.1 Unit pack
18 - 24.2 Multiple pack
18 - 24.3 On the syringe
19 - APPENDIX A - GUIDELINES FOR NON-REUSABLE AND ANTI-NEEDLE STICK INJURY SYRINGE-NEEDLE DEVICES
19 - A1 SCOPE
19 - A2 GENERAL
19 - A3 MECHANISMS FOR PREVENTING RE-USE OF THE SYRINGE COMPONENT
19 - A4 MECHANISMS FOR PREVENTING NEEDLE STICK INJURY BY THE NEEDLE COMPONENT
20 - APPENDIX B - METHOD FOR TESTING DURABILITY OF SCALE
20 - B1 SCOPE
20 - B2 PRINCIPLE
20 - B3 REAGENT
20 - B4 PROCEDURE
20 - B5 REPORT
21 - APPENDIX C - METHOD FOR TESTING FOR PRECISION OF SCALE
21 - C1 SCOPE
21 - C2 PRINCIPLE
21 - C3 APPARATUS AND MATERIALS
21 - C3.1 Blotting paper
21 - C3.2 Tared, stoppered weighing bottle
21 - C3.3 Laboratory balance
21 - C4 PROCEDURE
21 - C5 CALCULATION
21 - C6 REPORT
22 - APPENDIX D - METHOD FOR TESTING FIT OF PLUNGER IN BARREL UNDER PRESSURE
22 - D1 SCOPE
22 - D2 PRINCIPLE
22 - D3 APPARATUS
22 - D3.1 Air pressure system
22 - D3.2 Syringe holder
22 - D3.3 Device for applying lateral force
22 - D4 PROCEDURE
23 - D5 CALCULATION
23 - D6 REPORT
24 - APPENDIX E - METHOD FOR TESTING FIT OF PLUNGER IN BARREL UNDER SUCTION
24 - E1 SCOPE
24 - E2 PRINCIPLE
24 - E3 APPARATUS
24 - E3.1 Suction system
24 - E3.2 Syringe holder and spacer
24 - E4 PROCEDURE
24 - E5 REPORT
25 - APPENDIX F - METHOD FOR TESTING MOVEMENT OF PLUNGER IN BARREL
25 - F1 SCOPE
25 - F2 PRINCIPLE
25 - F3 APPARATUS
25 - F3.1 Testing machine
25 - F3.2 Syringe holder
25 - F4 PROCEDURE
25 - F5 REPORT
26 - APPENDIX G - METHOD FOR TESTING WATERTIGHTNESS OF CONNECTION BETWEEN NEEDLE HUB AND NOZZLE OF SYRINGE
26 - G1 SCOPE
26 - G2 PRINCIPLE
26 - G3 APPARATUS
26 - G3.1 Pressurizing device
26 - G3.2 Pressure gauge
26 - G4 PROCEDURE
27 - G5 REPORT
28 - APPENDIX H - METHOD FOR DETERMINING DEAD SPACE IN SYRINGES
28 - H1 SCOPE
28 - H2 PRINCIPLE
28 - H3 APPARATUS
28 - H4 PROCEDURE
28 - H5 CALCULATION
28 - H6 REPORT
29 - APPENDIX I - METHOD OF TESTING SYRINGES FOR PARTICULATE CONTAMINATION
29 - I1 SCOPE
29 - I2 PRINCIPLE
29 - I3 APPARATUS AND MATERIALS
29 - I3.1 Clean environment
29 - I3.2 Particle monitor
29 - I3.3 Suction filtration system
29 - I3.4 Microscope
29 - I3.5 Particle-free water
29 - I4 PROCEDURE
30 - I5 CALCULATION
30 - I6 REPORT
31 - APPENDIX J - METHOD OF TEST FOR REDUCING (OXIDIZABLE) MATTER
31 - J1 SCOPE
31 - J2 PRINCIPLE
31 - J3 REAGENTS
31 - J3.1 Water for injections, BP*
31 - J3.2 Potassium permanganate solution, 0.002 mol/L
31 - J3.3 Sulfuric acid solution, 1 mol/ L
31 - J3.4 Potassium iodide, BP*
31 - J3.5 Sodium thiosulfate solution, 0.01 mol/ L
31 - J3.6 Starch solution, BP*
31 - J4 APPARATUS
31 - J4.1 Borosilicate-glass flask
31 - J4.2 Oven
31 - J4.3 Conical flask
31 - J5 TEST SAMPLE
31 - J6 PROCEDURE
31 - J6.1 Preparation of extract
31 - J6.2 Blank solution
31 - J6.3 Test
31 - J6.4 Blank titration
32 - J7 CALCULATION
32 - J8 REPORT
33 - APPENDIX K - METHOD OF TEST FOR EXTRACTABLE TRACE METALS
33 - K1 SCOPE
33 - K2 PRINCIPLE
33 - K3 REAGENTS
33 - K3.1 Distilled water, BP*
33 - K3.2 Hydrochloric acid, BP*
33 - K3.3 Hydrochloric acid solution, 1 mol/L
33 - K4 APPARATUS
33 - K4.1 Atomic absorption spectrometer
33 - K4.2 Hollow-cathode lamp
33 - K5 TEST SOLUTION
33 - K6 PROCEDURE
33 - K6.1 Determination of trace metals
34 - K7 CALCULATION
34 - K8 REPORT
35 - APPENDIX L - METHOD OF TEST FOR NON-VOLATILE RESIDUE
35 - L1 SCOPE
35 - L2 PRINCIPLE
35 - L3 REAGENTS
35 - L4 APPARATUS
35 - L5 PROCEDURE
35 - L6 CALCULATION
35 - L7 REPORT
36 - APPENDIX M - METHOD OF TEST FOR ETHYLENE OXIDE AND ETHYLENE GLYCOL RESIDUES
36 - M1 SCOPE
36 - M2 PRINCIPLE
36 - M3 REAGENTS
36 - M3.1 Ethylene oxide
36 - M3.2 Ethylene glycol
36 - M3.3 Dimethylacetamide
36 - M4 APPARATUS
36 - M4.1 Gas chromatograph
36 - M4.2 Oven
36 - M4.3 Water bath
36 - M4.4 Polypropylene syringe
36 - M4.5 Stoppered vial
36 - M4.6 Eight stoppered vials
36 - M4.7 Hypodermic needle
36 - M5 PROCEDURE
36 - M5.1 Ethylene oxide in syringe material
37 - M5.2 Ethylene glycol in syringe material
38 - M6 REPORT
39 - APPENDIX N - METHOD OF TEST FOR PYROGENS (BACTERIAL ENDOTOXINS)
39 - N1 SCOPE
39 - N2 PRINCIPLE
39 - N3 REAGENTS FOR LAL TEST
39 - N3.1 LAL reagent water
39 - N3.2 Reference ‘standard’ endotoxin (RSE) and control ‘standard’ endotoxin (CSE)
39 - N3.3 LAL test kits
39 - N3.4 LAL reagent hydrochloric acid, 0.1 mol/ L and LAL reagent sodium hydroxide, 0.1 mol/L
39 - N4 APPARATUS FOR LAL TEST
39 - N4.1 Glassware, syringes and needles
39 - N4.2 Pyrogen-free capped test tubes
39 - N4.3 Pyrogen-free vessel
39 - N4.4 Incubation device
39 - N4.5 Autoclave
39 - N5 PREPARATION OF EXTRACTS FOR LAL TEST
39 - N5.1 Sterilized test material
39 - N5.2 Extractant
39 - N5.3 Sample extraction
40 - N6 PROCEDURE
40 - N6.1 Limulus amoebocyte lysate (LAL) test (Method A)
40 - N6.2 Rabbit pyrogen test (Method B)
40 - N7 VALIDATION OF THE LAL TEST
40 - N8 INTERPRETATION OF RESULTS
40 - N8.1 Method A
40 - N8.2 Method B
40 - N9 REPORT
41 - APPENDIX O - METHOD OF TEST FOR CYTOTOXICITY
41 - O1 SCOPE
41 - O2 DEFINITIONS
41 - O2.1 Cytotoxic titre
41 - O2.2 Positive control
41 - O2.3 Negative control
41 - O3 PRINCIPLE
41 - O4 REAGENTS
41 - O4.1 General
41 - O4.2 Hank’s balanced salt solution (HBSS)
41 - O4.3 Hank’s balanced salt solution, without calcium and magnesium
41 - O4.4 Trypsin solution, 0.001 25 g/ mL
42 - O4.5 Culture medium
42 - O4.6 Growth medium
42 - O4.7 Extraction medium
42 - O4.8 Neutral red solution (vital stain)
42 - O4.9 Formalin/crystal violet solution
42 - O4.10 Positive control
42 - O4.11 Negative control
43 - O5 APPARATUS AND MATERIALS
43 - O5.1 Sterile screw- capped vessels
43 - O5.2 Sterile 24-well culture dishes
43 - O5.3 Microscope
43 - O5.4 Haemacytometer
43 - O5.5 Glassware
43 - O5.6 Screw caps and liners
43 - O5.7 Screw-capped glass bottle
43 - O5.8 Laboratory balance
43 - O5.9 Sterile needles and needle covers
43 - O5.10 Sterile distilled water
43 - O6 PREPARATION OF CULTURE CELLS
43 - O6.1 VERO cells*
43 - O6.2 Cell maintenance
43 - O6.3 Cell subculture
44 - O6.4 Preparation of cell monolayer in culture test plates
44 - O7 TOXICITY TESTING OF EXTRACTS OF TEST AND CONTROL MATERIALS
44 - O7.1 Preparation of extract
45 - O7.2 Toxicity test
45 - O7.3 Assessment of toxicity
45 - O8 INTERPRETATION OF TEST RESULTS
46 - O9 REPORT
47 - APPENDIX P - RECOMMENDED METHOD FOR TESTING FOR INCOMPATIBILITY BETWEEN SYRINGES AND INJECTION FLUIDS
47 - P1 GENERAL
47 - P2 SOME SOLVENTS AND OTHER FLUIDS USED IN INJECTION FLUIDS
47 - P3 DETECTION OF VISIBLE AND FUNCTIONAL INCOMPATIBILITY BETWEEN SYRINGES AND INJECTABLE FLUIDS
47 - P4 REPORT

Specifies requirements for sterilized, single-use, Luer-fitting syringes, of nominal capacity from 1 mL to 50 mL, individually packed with or without detachable needles for general medical use. Guidelines for syringe-needle hypodermic devices designed to prevent accidental needle stick injuries or re-use of the syringe-needle combination after use are also provided. Materials, construction, packaging and marking requirements are laid down.

This Standard specifies requirements for sterilized single-use Luer-fitting syringes, of nominal capacity 1 mL, 2 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL and 50 mL, individually packed with or without detachable needles for general medical use.The Standard does not apply to aspiration or irrigation syringes or to syringes used in conjunction with syringe pumps.Guidelines for syringe-needle hypodermic devices designed to prevent accidental needle stick injuries or reuse of the syringe-needle combination (or both) after injection are provided.NOTES:1 The guidelines for such syringe-needle hypodermic devices are given in Appendix A.2 The sterile hypodermic syringes specified in this Standard are intended for use immediately after filling and are not intended for containing injectable fluids or samples over extended periods.3 Materials to be used for the construction of sterile syringes for single use are not specified in detail as their selection will depend, to some extent, upon the design, process of manufacture and method of sterilization employed by individual manufacturers. The materials should be compatible with injection substances included in the European or other relevant Pharmacopoeia, and where this is not the case the attention of the user should be drawn to the exception by labelling the unit pack.

First published as AS T39-1969.
Revised and redesignated AS 1094-1971.
Second edition 1981.
Third edition 1993.