Guide to Testing Methods and Standards for Ostomy Products

This document provides a comprehensive guide on testing methods and standards for ostomy products, focusing on key components like stoma braces, skin protectants, and ostomy washing appliances. It outlines detailed procedures for testing various properties and conditions, ensuring the safety, effectiveness, and quality of ostomy products. The document is based on Japan Industrial Standards and has been revised by relevant authorities.

Key Testing Areas Covered:
Physical Properties Testing:

Volume, Thickness, and Dimensions: Accurate measurement techniques for evaluating the physical characteristics of ostomy products.
Color and Transparency: Testing for visual properties to ensure consistency and quality.
Adhesive Properties: Evaluating adhesive strength and performance under specific conditions.
Water Absorption Tests for Skin Protectants:

Surface Water Absorption: Conducted using saline to measure how much water is absorbed by the skin protectants under specific conditions.
Odor Permeation Test:

Onion Odor Test: This test involves using a glass jar with an onion odor to determine if the materials used in the ostomy products allow odors to permeate after a specified period.
Material Health and Safety Tests:

pH Difference: Testing for changes in pH to assess material safety.
Heavy Metals: Checking for the presence of harmful heavy metals.
Potassium Permanganate Consumption: An additional test to assess the chemical safety of materials.
Test Conditions and Recording:
Tests are conducted under specified standard conditions with controlled room temperature and humidity.
All results are recorded with relevant details such as mean values, standard deviations, date, location, and any deviations from the specified procedures.
This guide ensures that manufacturers and regulators maintain high standards of safety, quality, and performance for ostomy products, with a focus on material health, functionality, and consumer comfort.

Source: https://public-comment.e-gov.go.jp/pcm/detail?CLASSNAME=PCMMSTDETAIL&id=495240196&Mode=0

Region:  Japan