AS 2385-1990

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

Specifies requirements for single-use sterile intravenous infusion sets for general medical use. It covers sets suitable for blood, blood derivatives and other intravenous fluids in general, and also sets suitable only for use with fluids containing no solid phase. Does not apply to certain types of sets for paediatric use or other sets such as microdip sets, pump sets and sets fitted with a central venous pressure monitoring device. Appendices include test methods for the determination of the physical, chemical and biological requirements of the infusion set.

This Standard specifies requirements for single-use sterile intravenous infusion sets intended for general medical use. It covers sets suitable for blood, blood derivatives and other intravenous fluids in general, and also sets suitable only for use with fluids containing no solid phase. The sets are intended to be restricted to one patient and not to be re-used.The Standard does not apply to certain types of sets for paediatric use or other sets such as microdrip sets, pump sets and sets fitted with a central venous pressure monitoring device. Requirements for devices for intravenous insertion-whether catheter, needle or cannula-are also not included.NOTE: The infusion sets covered in this Standard may not be suitable for the administration of platelet concentrates.