1 - AS 1079.4-1988 PACKAGING OF ITEMS (STERILE) FOR PATIENT CARE - FLEXIBLE PACKAGING SYSTEMS - FOR SINGLE USE IN HOSPITALS
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE.
6 - 2 REFERENCED DOCUMENTS.
6 - 3 DEFINITIONS.
6 - 3.1 Feathering
6 - 3.2 Flexible packaging system
6 - 3.3 In hospital use
6 - 4 PACKAGING MATERIAL REQUIREMENTS.
6 - 4.1 General.
6 - 4.2 Plastics and laminates.
7 - 4.3 Paper.
7 - 5 FIBRE LAY OF PAPER.
7 - 6 TEST LIMITS.
7 - 6.1 General.
7 - 6.2 Tensile strength of joints.
7 - 6.3 Determination of seal and seam stability when sterilized by steam under pressure.
7 - 6.4 Determination of seal and seam stability when sterilized by ethylene oxide.
7 - 6.5 Seam and seal integrity.
7 - 7 SUPPLY OF FLEXIBLE PACKAGING SYSTEMS
7 - 8 MARKING.
7 - 8.1 General.
7 - 8.2 Sterilization process indicator.
8 - 8.3 Batch number.
8 - 8.4 Unit packages.
8 - 8.5 On the outside of the transport package.
9 - APPENDIX A - DETERMINATION OF IMPACT RESISTANCE (FALLING DART IMPACT TEST)
9 - A1 SCOPE.
9 - A2 APPLICATION.
9 - A3 APPARATUS.
9 - A3.1 Specimen clamp.
9 - A3.2 Dart holder.
9 - A3.3 Dart.
9 - A3.4 Cushioning and shielding devices.
9 - A4 TEST SPECIMENS.
9 - A5 PROCEDURE.
9 - A6 REPORT.
11 - APPENDIX B - TESTING FOR FLUORESCENT SUBSTANCES IN PAPER
11 - B1 SCOPE.
11 - B2 PRINCIPLE.
11 - B3 APPARATUS.
11 - B4 SPECIMENS.
11 - B5 PROCEDURE.
11 - B6 REPORT.
12 - APPENDIX C - DETERMINATION OF FIBRE LAY OF PAPER
12 - C1 SCOPE.
12 - C2 APPARATUS.
12 - C3 TEST SAMPLES.
12 - C4 PROCEDURE.
12 - C5 REPORT.
13 - APPENDIX D - DETERMINATION OF JOINT STRENGTH
13 - D1 SCOPE.
13 - D2 APPARATUS.
13 - D3 PROCEDURE.
13 - D4 REPORT.
14 - APPENDIX E - DETERMINATION OF STABILITY TO STERILIZATION BY SATURATED STEAM UNDER PRESSURE
14 - E1 SCOPE.
14 - E2 APPARATUS.
14 - E3 PROCEDURE.
14 - E4 REPORT.
15 - APPENDIX F - DETERMINATION OF STABILITY TO STERILIZATION BY ETHYLENE OXIDE
15 - F1 SCOPE.
15 - F2 APPARATUS.
15 - F3 PROCEDURE.
15 - F4 REPORT.
16 - APPENDIX G - DETERMINATION OF SEAM AND SEAL INTEGRITY
16 - G1 SCOPE.
16 - G2 PRINCIPLE.
16 - G3 REAGENT.
16 - G3.1 Distilled water,
16 - G3.2 Crystal violet dye
16 - G3.3 TERIC X-10 surfactant (I.C.I.),
16 - G3.4 Preparation of test solution.
16 - G4 PROCEDURE.
16 - G5 REPORT.
17 - APPENDIX H - REFERENCES FOR MICROBIAL BARRIER TESTING