AS/NZS 2869:1995

1 - AS/NZS 2869: 1995 TAMPONS - MENSTRUAL
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE
7 - 2 OBJECTIVE
7 - 3 REFERENCED DOCUMENTS
7 - 4 DEFINITIONS
7 - 4.1 Aseptic technique
8 - 4.2 Batch
8 - 4.3 Contamination
8 - 4.4 Disinfectant
8 - 4.5 Disinfection
8 - 4.6 Menstrual tampon
8 - 4.7 Packaging
8 - 4.8 Sterilization
8 - 5 MATERIALS
8 - 5.1 Permissible materials
8 - 5.2 Freedom from toxic and irritant effect
8 - 5.3 Freedom from impurities
8 - 5.4 Ether soluble substances
9 - 6 DESIGN REQUIREMENTS
9 - 6.1 Length of withdrawal cord
9 - 6.2 Applicator
9 - 7 PERFORMANCE REQUIREMENTS
9 - 7.1 Absorptive capacity
9 - 7.2 Pull strength of withdrawal cord and its attachment point
9 - 7.3 Water repellency of withdrawal cord
9 - 8 MICROBIAL CONTENT
9 - 9 PACKAGING
9 - 10 MARKING
9 - 10.1 Primary packs
11 - 10.2 Supply packs
11 - 10.3 Manufacturer’s details
11 - 10.4 Transport pack
11 - 11 INFORMATION LEAFLET
12 - APPENDIX C - METHOD FOR MEASURING ABSORPTIVE CAPACITY
12 - C1 SCOPE
12 - C2 PRINCIPLE
12 - C3 APPARATUS
12 - C4 DESCRIPTION OF OPERATION OF SYNGINA (see Figure C1)
12 - C5 SAMPLE NUMBER
15 - C6 TEST SPECIMENS
15 - C7 PROCEDURE
15 - C8 INVALID TEST
15 - C9 TEST REPORT
16 - APPENDIX D - METHOD FOR TESTING THE STRENGTH OF THE WITHDRAWAL CORD AND ITS ATTACHMENT TO THE TAMPON
16 - D1 SCOPE
16 - D2 PRINCIPLE
16 - D3 APPARATUS
17 - D4 TEST SPECIMENS
17 - D5 PROCEDURE
17 - D6 INVALID TEST
17 - D7 TEST REPORT
21 - APPENDIX E - METHOD FOR DETERMINING THE WATER REPELLENCY OF THE WITHDRAWAL CORD
21 - E1 SCOPE
21 - E2 PRINCIPLE
21 - E3 APPARATUS
21 - E4 TEST SPECIMENS
21 - E5 PROCEDURE
21 - E6 TEST REPORT
22 - APPENDIX F - METHOD FOR DETERMINING TOTAL AEROBIC MICROBIAL COUNT
22 - F1 SCOPE
22 - F2 PRINCIPLE
22 - F3 LABORATORY PRACTICES AND PRECAUTIONS
22 - F4 APPARATUS
22 - F5 CULTURE MEDIA AND REAGENTS
23 - F6 LABORATORY CONDITIONS
23 - F7 TEST SPECIMEN
23 - F8 PROCEDURE
23 - F9 DETERMINATION OF AEROBIC COUNT
24 - F10 TEST REPORT
25 - APPENDIX G - EXAMPLE OF INFORMATION ON TSS FOR INCLUSION IN INFORMATION LEAFLET
27 - APPENDIX H - EXAMPLE OF SAMPLE SIZE CALCULATION
27 - H1 SCOPE
27 - H2 STATISTICAL SAMPLING
27 - H3 DETERMINATION OF PROCESS CAPABILITY
27 - H4 DETERMINATION OF SAMPLE SIZE
28 - H5 DETERMINATION OF ABSORBENCY RANGE

Specifies requirements for menstrual tampons including length, pull strength and water repellency of the withdrawal cord, materials, absorptive capacity, microbial content, marking and packaging. Information to be given in an accompanying leaflet is described. A classification system based on tampon absorbancy is given, and includes descriptive terms to be used in labelling tampons according to their absorbancy range.

This Standard specifies requirements for menstrual tampons, including the specific absorptive capacity, microbial content, withdrawal cord pull strength and water repellency, marking and packaging. Information to be included in an accompanying leaflet is described.

First published as AS 2869-1986.
Jointly revised and redesignated as Joint Standard AS/NZS 2869:1995.