AS 1079.4-1988

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

Specifies requirements for flexible packaging systems used for packaging items for patient care intended to be sterilized in hospitals by saturated steam under pressure or by ethylene oxide.

This Standard specifies requirements for flexible packaging systems used for packaging items for patient care and intended to be sterilized in hospitals by saturated steam under pressure or by ethylene oxide. The systems for single use may be formed from a single web of paper or plastics, or by bonding (laminating) two or more layers of paper or plastics together. NOTE: Paper bags for hospital use are described in AS 1079.3.