AS 2869-2008

Table of Contents

1 -  AS 2869-2008 TAMPONS-MENSTRUAL
4 -  PREFACE
5 -  CONTENTS
6 -  FOREWORD
7 -  1 SCOPE
7 -  2 OBJECTIVE
7 -  3 REFERENCED DOCUMENTS
8 -  4 DEFINITIONS
8 -  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 -  4.9 Syngina
9 -  5 MATERIALS
9 -  5.1 Permissible materials
9 -  5.2 Freedom from toxic and irritant effect
9 -  5.3 Freedom from impurities
9 -  5.4 Ether soluble substances
9 -  5.4.1 Requirement
9 -  5.4.2 Test specimen
9 -  6 DESIGN REQUIREMENTS
9 -  6.1 Length of withdrawal cord
9 -  6.2 Applicator
10 -  7 PERFORMANCE REQUIREMENTS
10 -  7.1 Absorptive capacity
10 -  7.2 Pull strength of withdrawal cord and its attachment point
10 -  7.3 Water repellency of withdrawal cord
10 -  8 MICROBIAL CONTENT
10 -  9 PACKAGING
10 -  10 MARKING
10 -  10.1 Primary packs
11 -  10.2 Supply packs
11 -  10.3 Manufacturer’s details
11 -  10.4 Transport pack
12 -  11 INFORMATION LEAFLET
13 -  APPENDIX A - METHOD FOR MEASURING ABSORPTIVE CAPACITY
13 -  A1 SCOPE
13 -  A2 PRINCIPLE
13 -  A3 APPARATUS
14 -  A4 MATERIALS AND REAGENTS
14 -  A5 SAMPLE SIZE
14 -  A6 PREPARATION OF TEST SPECIMENS
17 -  A7 PROCEDURE
18 -  A8 INVALID TEST
18 -  A9 TEST REPORT
19 -  APPENDIX B - METHOD FOR TESTING THE STRENGTH OF THE WITHDRAWAL CORD AND ITS ATTACHMENT TO THE TAMPON
19 -  B1 SCOPE
19 -  B2 PRINCIPLE
19 -  B3 APPARATUS
20 -  B4 TEST SPECIMENS
20 -  B5 PROCEDURE
20 -  B5.1 Dry state
20 -  B5.2 Wet state
21 -  B6 INVALID TEST
21 -  B7 TEST REPORT
25 -  APPENDIX C - METHOD FOR DETERMINING THE WATER REPELLENCY OF THE WITHDRAWAL CORD
25 -  C1 SCOPE
25 -  C2 PRINCIPLE
25 -  C3 APPARATUS
25 -  C4 TEST SPECIMENS
25 -  C5 PROCEDURE
25 -  C6 TEST REPORT
26 -  APPENDIX D - METHOD FOR DETERMINING TOTAL AEROBIC MICROBIAL COUNT
26 -  D1 SCOPE
26 -  D2 PRINCIPLE
26 -  D3 LABORATORY PRACTICES AND PRECAUTIONS
26 -  D4 APPARATUS
27 -  D5 CULTURE MEDIA AND REAGENTS
27 -  D6 LABORATORY CONDITIONS
27 -  D7 TEST SPECIMEN
27 -  D8 PROCEDURE
28 -  D9 DETERMINATION OF AEROBIC COUNT
29 -  D10 TEST REPORT
30 -  APPENDIX E - EXAMPLE OF INFORMATION ON TSS FOR INCLUSION IN INFORMATION LEAFLET
30 -  E1 SCOPE
30 -  E2 CONTENT OF LEAFLET
30 -  E3 EXAMPLE OF WORDING
32 -  E4 ADVICE TO MANUFACTURERS
33 -  APPENDIX F - EXAMPLE OF SAMPLE SIZE CALCULATION
33 -  F1 SCOPE
33 -  F2 STATISTICAL SAMPLING
33 -  F3 DETERMINATION OF PROCESS CAPABILITY
34 -  F4 DETERMINATION OF SAMPLE SIZE
34 -  F5 DETERMINATION OF ABSORBENCY RANGE

Abstract

Specifies the materials to be used and the performance requirements for the absorptive capacity of the tampon, the strength and water repellency of the withdrawal cord and the total aerobic microbial count of the tampon and applicator where provided. Packaging, marking and information labelling are also specified and an example of an information leaflet on Toxic Shock Syndrome is included in an appendix.

Scope

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
Pages
ISBN
Committee	CS-065
Supersedes	AS/NZS 2869:1998 DR 08057