ISO/TR 22219 Testing of Skin Barrier Function

Comprehensive Guide to ISO/TR 22219 Testing of Skin Barrier Function Laboratory Testing Service Provided by Eurolab

ISO/TR 22219 is a technical report that outlines the requirements for testing the skin barrier function. This document provides guidance on the selection and use of methods for assessing the skin barrier function, as well as the evaluation of test results.

The standard is published by the International Organization for Standardization (ISO) and is available in multiple languages. The ISO/TR 22219 report is not a mandatory standard, but rather a technical report that provides guidance on best practices for testing skin barrier function.

Relevant Standards

Legal and Regulatory Framework

The skin barrier function is a critical aspect of human health, and the testing of skin barrier function is subject to various regulations and laws. In Europe, for example, the use of personal protective equipment (PPE) is governed by the Personal Protective Equipment Regulation (EU) 2016/425.

In the United States, the Occupational Safety and Health Administration (OSHA) regulates PPE under the OSHA Regulations (29 CFR Part 1910). The Food and Drug Administration (FDA) also regulates certain products that come into contact with skin, such as cosmetics and pharmaceuticals.

Standard Development Organizations

Standard development organizations (SDOs) play a critical role in developing standards for testing skin barrier function. SDOs include:

Standard Evolution and Update

Standards for testing skin barrier function are subject to periodic review and update. This ensures that the standards remain relevant and effective in protecting public health.

For example, ISO/TR 22219 was first published in 2019 and is currently under revision. The revised standard will include updated test methods and criteria for evaluating skin barrier function.

Standard Numbers and Scope

The following table provides an overview of some of the key standards related to testing skin barrier function:

Standard Number Title Scope

--- --- ---

ISO/TR 22219 Skin barrier function - Testing Provides guidance on selecting and using methods for assessing skin barrier function

ASTM E2557-17 Standard Guide for Evaluating the Effectiveness of Barrier Creams and Moisturizers in Reducing Irritation and Dryness Evaluates the effectiveness of barrier creams and moisturizers in reducing irritation and dryness

EN 1499:2006A1:2010 Protective gloves against mechanical risks - Requirements and testing Specifies requirements for protective gloves against mechanical risks

Industry-Specific Standards

The following table provides an overview of some of the key industry-specific standards related to testing skin barrier function:

Industry Standard Number Title

--- --- ---

Personal Protective Equipment (PPE) EU 2016/425 Personal Protective Equipment Regulation

Cosmetics FDA Regulation 21 CFR Part 701.1 Labeling and Packaging Requirements for Cosmetics

The testing of skin barrier function is a critical aspect of ensuring public health and safety. This section provides an overview of the standard requirements and needs for testing skin barrier function.

Why Test Skin Barrier Function?

Testing skin barrier function is essential to ensure that products do not cause irritation, dryness, or other adverse effects on human skin. The testing of skin barrier function helps to:

Business and Technical Reasons for Conducting ISO/TR 22219 Testing

The business and technical reasons for conducting ISO/TR 22219 testing include:

Consequences of Not Performing This Test

Failing to conduct ISO/TR 22219 testing can have serious consequences, including:

Industries and Sectors that Require This Testing

The following industries and sectors require ISO/TR 22219 testing:

This section provides an overview of the standard implementation and testing for ISO/TR 22219.

Test Methods

The following table provides an overview of some of the key test methods for assessing skin barrier function:

Test Method Description

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Skin Irritation/Contact Dermatitis (SICD) Evaluates the potential of a substance to cause irritation or contact dermatitis on human skin

Skin Dryness/Moisturization (SDM) Evaluates the effectiveness of a moisturizer in reducing dryness and improving skin hydration

Barrier Cream/Moisturizer Efficacy (BCME) Evaluates the efficacy of a barrier cream or moisturizer in reducing irritation and dryness

Test Criteria

The following table provides an overview of some of the key test criteria for evaluating skin barrier function:

Test Criterion Description

--- ---

Irritation Score Measures the level of irritation caused by a substance on human skin

Dryness Score Measures the level of dryness caused by a substance on human skin

Moisturization Index Measures the effectiveness of a moisturizer in reducing dryness and improving skin hydration

Test Protocol

The following table provides an overview of some of the key steps involved in conducting ISO/TR 22219 testing:

Step Description

--- ---

Selection of Test Subjects Selects test subjects for testing, based on factors such as age, sex, and skin type

Preparation of Test Materials Prepares test materials, including substances to be tested and barrier creams or moisturizers

Conducting the Test Conducts the test according to established protocols and criteria

Evaluation of Results Evaluates test results, using established criteria and scoring systems

In conclusion, ISO/TR 22219 testing is a critical aspect of ensuring public health and safety. The standard provides guidance on selecting and using methods for assessing skin barrier function, as well as evaluating test results.

The business and technical reasons for conducting ISO/TR 22219 testing include ensuring compliance with regulatory requirements, protecting public health and safety, enhancing product performance and efficacy, mitigating liability risks associated with skin irritation or dryness, and improving brand reputation and customer confidence.

The consequences of not performing this test can be serious, including non-compliance with regulatory requirements, product recalls due to adverse effects on human skin, liability risks associated with skin irritation or dryness, and damage to brand reputation and customer confidence.

In order to ensure compliance with regulatory requirements and protect public health and safety, it is essential to conduct ISO/TR 22219 testing. This can be achieved by following the standard implementation and testing guidelines outlined in this guide.

The following references provide further information on ISO/TR 22219 testing:

The following glossary provides definitions for key terms related to ISO/TR 22219 testing:

The following test protocols provide a detailed outline for conducting ISO/TR 22219 testing:

The following sample forms and templates provide a starting point for creating test protocols, evaluation forms, and other documentation: