AS 1946-1984

1 - AS 1946-1984 HYPODERMIC EQUIPMENT - SINGLE-USE NEEDLES (STERILE) FOR GENERAL MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE.
6 - 2 REFERENCED DOCUMENTS.
6 - 3 DESCRIPTION OF NEEDLE.
6 - 4 DEFINITIONS.
6 - 4.1 Unit
6 - 4.2 Point
6 - 4.3 Heel
6 - 4.4 Angle of point
6 - 4.5 Water
7 - 4.6 Needle sheath
7 - 4.7 Bore
7 - 4.8 Unit pack
7 - 4.9 Multiple pack
7 - 4.10 Store pack
7 - 5 REQUIREMENTS FOR NEEDLE TUBE.
7 - 5.1 Composition.
7 - 5.2 Appearance.
7 - 5.3 Resistance to corrosion.
7 - 5.4 Dimensions.
7 - 5.5 Finish of point.
7 - 5.6 Mechanical properties.
7 - 6 REQUIREMENTS FOR HUB.
7 - 6.1 Composition.
7 - 6.2 Appearance.
7 - 6.3 Cleanliness.
7 - 6.4 Shape and dimensions.
7 - 6.5 Colour coding.
7 - 7 JOINT OF NEEDLE TUBE WITH HUB.
7 - 7.1 Watertightness.
7 - 7.2 Strength.
7 - 8 DEAD SPACE.
9 - 9 EXTRACTABLE METALS.
9 - 10 PYROGENS.
9 - 11 TOXICITY.
9 - 12 STERILIZATION.
9 - 13 STERILITY.
9 - 14 PARTICULATE CONTAMINATION.
9 - 15 PACKAGING.
9 - 15.1 Sheath.
9 - 15.2 Unit pack.
9 - 15.3 Multiple pack.
9 - 15.4 Store pack.
9 - 16 LABELLING.
9 - 16.1 On the unit pack.
9 - 16.2 On the multiple pack.
10 - 16.3 On the store pack.
11 - APPENDIX A - METHOD OF TESTING NEEDLES FOR RESISTANCE TO CORROSION
11 - A1 SCOPE.
11 - A2 PRINCIPLE.
11 - A3 REAGENT.
11 - A4 PROCEDURE.
11 - A5 REPORT.
12 - APPENDIX B - METHOD FOR TESTING STIFFNESS OF NEEDLE
12 - B1 SCOPE.
12 - B2 PRINCIPLE.
12 - B3 APPARATUS.
12 - B4 PROCEDURE.
12 - B5 REPORT.
13 - APPENDIX C - METHOD FOR TESTING RESISTANCE OF NEEDLE TO BENDING
13 - C1 SCOPE.
13 - C2 PRINCIPLE.
13 - C3 APPARATUS.
13 - C4 PROCEDURE.
13 - C5 REPORT.
15 - APPENDIX D - METHOD FOR TESTING ELASTIC RECOVERY OF NEEDLE
15 - D1 SCOPE.
15 - D2 PRINCIPLE.
15 - D3 APPARATUS.
15 - D4 PROCEDURE.
15 - D5 REPORT.
17 - APPENDIX E - METHOD OF TESTING HUB FOR CLEANLINESS
17 - E1 SCOPE.
17 - E2 PRINCIPLE.
17 - E3 PROCEDURE.
17 - E4 REPORT.
18 - APPENDIX F - METHOD FOR TESTING WATERTIGHTNESS OF JOINT BETWEEN NEEDLE TUBE AND HUB
18 - F1 SCOPE.
18 - F2 PRINCIPLE.
18 - F3 APPARATUS.
18 - F4 PROCEDURE.
18 - F5 REPORT.
19 - APPENDIX G - METHOD FOR TESTING STRENGTH OF JOINT BETWEEN NEEDLE TUBE AND HUB
19 - G1 SCOPE.
19 - G2 PRINCIPLE.
19 - G3 APPARATUS.
19 - G4 PROCEDURE.
19 - G4.1 Needle as received.
19 - G4.2 Needle after bending.
19 - G5 REPORT.
20 - APPENDIX H - METHOD FOR DETERMINING DEAD SPACE IN NEEDLES
20 - H1 SCOPE.
20 - H2 PRINCIPLE.
20 - H3 APPARATUS.
20 - H4 PROCEDURE.
20 - H5 CALCULATION AND REPORT.
21 - APPENDIX J - METHOD FOR DETERMINING EXTRACTABLE METALS IN NEEDLES
21 - J1 SCOPE.
21 - J2 PRINCIPLE.
21 - J3 APPARATUS AND MATERIALS.
21 - J4 PROCEDURE.
21 - J4.1 Preparation of test extract.
21 - J4.2 Determination of extractable metals.
21 - J5 REPORT.
22 - APPENDIX K - METHOD OF TESTING NEEDLES FOR PYROGENS
22 - K1 SCOPE.
22 - K2 GENERAL PROCEDURE.
22 - K3 PREPARATION OF TEST SOLUTION.
22 - K4 CRITERIA.
23 - APPENDIX L - METHOD OF TESTING NEEDLES FOR TOXICITY
23 - L1 SCOPE.
23 - L2 PRINCIPLE.
23 - L3 PREPARATION OF TEST SOLUTION.
23 - L4 PROCEDURE.
23 - L5 CRITERIA FOR PASSING AND REPEATTESTING.
24 - APPENDIX N - METHOD OF TESTING NEEDLES FOR PARTICULATE CONTAMINATION
24 - N1 SCOPE.
24 - N2 PRINCIPLE.
24 - N3 APPARATUS AND MATERIALS.
24 - N4 PROCEDURE.
25 - N5 CALCULATION AND REPORT.
26 - APPENDIX O - METHOD OF TEST FOR LEAKAGE OF UNIT PACK*
26 - O1 SCOPE.
26 - O2 PRINCIPLE.
26 - O3 REAGENT.
26 - O4 APPARATUS.
26 - O5 PROCEDURE.
26 - O6 REPORT.
27 - APPENDIX P - ASSESSMENT OF COMPLIANCE
27 - P1 SCOPE.
27 - P2 CERTIFICATION MARKING.
27 - P3 ASSESSMENT OF COMPLIANCE ON THE BASIS OF A SINGLE SAMPLE.

Specifies requirements for sterilized, individually packed hypodermic needles intended for use once only. The needle tubes are from 0.45 mm to 1.25 mm in nominal external diameter. The needles have the 6 percent (Luer) fitting. Requirements for the needle tube, mechanical properties, requirements for the hub, dead space limits, packaging and labelling are given. Appendices include tests for extractable metals, pyrogens, toxicity and sterility.

This standard specifies requirements for sterilized individually packed hypodermic needles intended for use once only. The needle tubes are from 0.45 mm to 1.25 mm in nominal external diameter. The needles have the 6 percent (Luer) fitting.NOTE: Advisory information on sampling and assessing for compliance with this standard is given in Appendix P.

Reconfirmed 1995
Under Revision see DR 01257