AS 2869:2022 PDF

AS 2869:2022 PDF

AS 2869:2022 specifies requirements for menstrual tampons, including the specific absorptive capacity, microbial content, withdrawal cord pull strength and water repellency, marking and packaging. It also provides sample information to be included in an accompanying leaflet, such as information about toxic shock syndrome, precautions and instructions for correct use.

The objective of this document is to provide requirements for the manufacture of tampons in order to minimize known health hazards associated with the use of tampons, and so they are of appropriate quality and performance when supplied to consumers.

This document is intended as a manufacturing specification which is achievable by a manufacturer that adheres to an appropriate quality management system.

The major changes in this edition are as follows:

(a) Harmonization of the absorbency ranges with the EDANA (European) Code of Practice for Tampon Labeling.

(b) An increased absorbency range of greater than 15 g up to and including 18 g has been added.

(c) Primary absorbency labelling markings have been amended to include an appropriate descriptor to denote the range of absorbency.

(d) Optional secondary absorbency labelling markings have been added which include the use of the appropriate number of droplets and/or approximate absorbency.

(e) Details to be included in the information leaflet have been listed.

(f) Microbial content has been updated to provide for use of either an Australian or international pharmacopoeial test methods for determining aerobic microbial count.

(g) The ether soluble substances test has been deleted as this test did not reflect any absorbency performance attribute and offered no additional value for safety.