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 Hanks balanced salt solution (HBSS)
41 - O4.3 Hanks 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