1 - AS 2385-1990 SINGLE-USE (STERILE) INFUSION SETS FOR GENERAL MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE
7 - 2 REFERENCED DOCUMENTS
7 - 3 DEFINITIONS
7 - 3.1 Set
7 - 3.2 Blood set
7 - 3.3 Solution set
7 - 3.4 Closure-piercing device
7 - 3.5 Drip chamber
7 - 3.6 Filter chamber
7 - 3.7 Drip-filter chamber
7 - 3.8 Drip tube
7 - 3.9 Blood filter
7 - 3.10 Fluid filter
8 - 3.11 Delivery tube
8 - 3.12 Adaptor
8 - 3.13 Injection site
8 - 3.14 Flow regulator
8 - 3.15 Connecting tube
8 - 3.16 Intravenous injection device
8 - 3.17 Air-inlet assembly
8 - 3.18 Air filter
8 - 3.19 Air needle
8 - 3.20 End protectors
8 - 3.21 Unit
8 - 3.22 Unit pack
8 - 3.23 Store pack
8 - 4 MATERIALS
8 - 4.1 General
8 - 4.2 Liquid pathway
8 - 5 SPECIFIC REQUIREMENTS FOR BLOOD SET
8 - 5.1 Components
8 - 5.2 Construction
10 - 6 SPECIFIC REQUIREMENTS FOR SOLUTION SET
10 - 6.1 Components
10 - 6.2 Construction
12 - 7 DELIVERY RATE
12 - 8 FREEDOM FROM LEAKAGE OF AIR
12 - 8.1 Under increased pressure
12 - 8.2 Under reduced pressure
12 - 9 CYTOTOXICITY
12 - 10 PYROGENICITY
12 - 11 STERILITY
12 - 12 HAEMOLYTIC EFFECTS
12 - 13 INTRACUTANEOUS REACTIVITY
12 - 14 PARTICULATE CONTAMINATION
12 - 15 REDUCING (OXIDIZABLE) MATTER
12 - 16 EXTRACTABLE TRACE METALS
12 - 17 NON-VOLATILE RESIDUE
12 - 18 ABSORBANCE
12 - 19 ALKYLENE OXIDE GAS RESIDUES
13 - 20 END PROTECTORS
13 - 20.1 Unit pack
13 - 20.2 Store pack
13 - 21 MARKING
13 - 21.1 On the unit pack
13 - 21.2 On the store pack
14 - APPENDIX A - METHOD OF TEST FOR RESISTANCE TO CORROSION OF THE CLOSURE-PIERCING DEVICE
14 - A1 SCOPE
14 - A2 PRINCIPLE
14 - A3 REAGENTS
14 - A4 APPARATUS
14 - A5 PROCEDURE
14 - A6 REPORT
15 - APPENDIX B - METHOD FOR TESTING CLOSURE PIERCING
15 - B1 SCOPE
15 - B2 PRINCIPLE
15 - B3 APPARATUS
15 - B4 PROCEDURE
15 - B5 REPORT
16 - APPENDIX C - METHOD OF TEST FOR LEAKAGE OF AIR UNDER INCREASED PRESSURE
16 - C1 SCOPE
16 - C2 PRINCIPLE
16 - C3 APPARATUS
16 - C4 PROCEDURE
16 - C4.1 Sets without integral air-inlet assembly
16 - C4.2 Sets with integral air-inlet assembly
16 - C5 REPORT
17 - APPENDIX D - METHOD OF TEST FOR LEAKAGE OF AIR UNDER REDUCED PRESSURE
17 - D1 SCOPE
17 - D2 PRINCIPLE
17 - D3 APPARATUS
17 - D4 PROCEDURE
17 - D4.1 Sets without air-inlet assembly
17 - D4.2 Sets with separate air-inlet assembly
18 - D4.3 Sets with integral air-inlet assembly
18 - D5 REPORT
19 - APPENDIX E - METHOD FOR TESTING DELIVERY RATE
19 - E1 SCOPE
19 - E2 PRINCIPLE
19 - E3 APPARATUS
19 - E4 PROCEDURE
19 - E5 REPORT
20 - APPENDIX F - METHOD OF TEST FOR CYTOTOXICITY
20 - F1 SCOPE
20 - F2 DEFINITIONS
20 - F2.1 Cytotoxic titre
20 - F2.2 Positive control
20 - F2.3 Negative control
20 - F3 PRINCIPLE
20 - F4 REAGENTS
20 - F4.1 General
20 - F4.2 Hank’s Balanced Salt Solution (HBSS)
20 - F4.3 Hank’s Balanced Salt Solution, without calcium and magnesium
20 - F4.4 Trypsin solution, 0.00125 g/mL
20 - F4.5 Culture medium
20 - F4.6 Growth medium
20 - F4.7 Extraction medium
21 - F4.8 Neutral red solution (Vital Stain)
21 - F4.9 Formalin-crystal violet solution
21 - F4.10 Positive control
21 - F4.11 Negative control
21 - F5 APPARATUS AND MATERIALS
21 - F6 PREPARATION OF CULTURE CELLS
21 - F6.1 VERO cells*
21 - F6.2 Cell maintenance
21 - F6.3 Cell subculture
22 - F6.4 Preparation of cell monolayer in culture test plates
22 - F7 TOXICITY TESTING OF EXTRACTS OF TEST AND CONTROL MATERIALS
22 - F7.1 Preparation of extract
22 - F7.2 Toxicity test
22 - F7.3 Assessment of toxicity
23 - F8 INTERPRETATION OF TEST RESULTS
23 - F9 REPORT
24 - APPENDIX G - METHOD OF TEST FOR PYROGENS (BACTERIAL ENDOTOXINS)
24 - G1 SCOPE
24 - G2 PRINCIPLE
24 - G3 REAGENTS FOR LAL TEST
24 - G3.1 LAL Reagent water
24 - G3.2 Reference ‘Standard’ endotoxin (RSE) and control ‘Standard’ endotoxin (CSE)
24 - G3.3 LAL test kits
24 - G3.4 LAL Reagent hydrochloric acid, 0.1 mol/L and LAL Reagent sodium hydroxide, 0.1 mol/L
24 - G4 APPARATUS FOR LAL TEST
24 - G4.1 Glassware, syringes and needles,
24 - G4.2 Pyrogen-free capped test tubes,
24 - G4.3 Incubation device,
24 - G4.4 Autoclave
24 - G5 PREPARATION OF EXTRACTS FOR LAL TEST
24 - G5.1 Pre-sterilized test material
24 - G5.2 Non-sterile test material
24 - G5.3 Extractant
24 - G5.4 Sample extraction
24 - G6 VALIDATION OF THE LAL TEST
24 - G7 PROCEDURE
24 - G7.1 Limulus amoebocyte lysate
24 - G7.2 Rabbit pyrogen test (Method B)
25 - G8 INTERPRETATION OF RESULTS
25 - G8.1 Method A
25 - G8.2 Method B
25 - G9 REPORT
26 - APPENDIX H - METHOD OF TEST FOR HAEMOLYTIC EFFECTS
26 - H1 SCOPE
26 - H2 PRINCIPLE
26 - H3 REAGENTS
26 - H3.1 Rabbit blood,
26 - H3.2 Saponin solution,
26 - H3.3 Sodium chloride solution, 0.9% B.P
26 - H4 APPARATUS
26 - H4.1 Autoclave
26 - H4.2 Centrifuge,
26 - H4.3 Centrifuge tubes,
26 - H4.4 Screw-capped glass container,
26 - H4.5 Spectrophotometer,
26 - H4.6 Water-bath
26 - H5 PREPARATION OF BLOOD SOLUTION AND EXTRACT
26 - H5.1 Preparation of blood solution
26 - H5.2 Preparation of extract
26 - H6 TEST PROCEDURE
26 - H7 CALCULATION
26 - H8 REPORT
27 - APPENDIX I - METHOD OF TEST FOR PARTICULATE CONTAMINATION
27 - I1 SCOPE
27 - I2 PRINCIPLE
27 - I3 APPARATUS AND MATERIALS
27 - I4 PROCEDURE
28 - I5 CALCULATION
28 - I6 REPORT
29 - APPENDIX J - METHOD OF TEST FOR REDUCING (OXIDIZABLE) MATTER
29 - J1 SCOPE
29 - J2 PRINCIPLE
29 - J3 REAGENTS
29 - J4 APPARATUS
29 - J5 TEST SAMPLE
29 - J6 PROCEDURE
29 - J6.1 Preparation of extract
29 - J6.2 Preparation of blank
29 - J6.3 Test
29 - J6.4 Blank titration
29 - J7 CALCULATION
29 - J8 REPORT
30 - APPENDIX K - METHOD OF TEST FOR EXTRACTABLE TRACE METALS
30 - K1 SCOPE
30 - K2 PRINCIPLE
30 - K3 REAGENTS
30 - K3.1 Distilled water
30 - K3.2 Hydrochloric acid, B.P
30 - K3.3 Hydrochloric acid solution, 1 mol/L,
30 - K4 APPARATUS
30 - K4.1 Atomic absorption spectrometer,
30 - K4.2 Hollow-cathode lamp,
30 - K5 TEST SOLUTION
30 - K6 PROCEDURE
30 - K6.1 Determination of trace metals
30 - K7 CALCULATION
30 - K8 REPORT
31 - APPENDIX L - METHOD OF TEST FOR NON-VOLATILE RESIDUE
31 - L1 SCOPE
31 - L2 PRINCIPLE
31 - L3 REAGENTS
31 - L4 APPARATUS
31 - L5 PROCEDURE
31 - L6 CALCULATION
31 - L7 REPORT
32 - APPENDIX M - METHOD OF TEST FOR ABSORBANCE
32 - M1 SCOPE
32 - M2 PRINCIPLE
32 - M3 REAGENTS
32 - M4 APPARATUS
32 - M5 PROCEDURE
32 - M6 REPORT
33 - APPENDIX N - METHOD OF TEST FOR ALKYLENE (ETHYLENE OR PROPYLENE) OXIDE GAS RESIDUES
33 - N1 SCOPE
33 - N2 PRINCIPLE
33 - N3 REAGENTS
33 - N4 APPARATUS
33 - N4.1 Gas chromatograph,
33 - N4.2 Oven,
33 - N4.3 Water bath,
33 - N4.4 Gas-tight syringe,
33 - N4.5 Microlitre syringe,
33 - N4.6 Three gas-tight vials,
33 - N5 PROCEDURE
33 - N5.1 Alkylene oxide in plastics material
34 - N5.2 Alkylene chlorohydrin and alkylene glycol in plastics material
34 - N6 REPORT