ISO 10993-17 Toxicological Risk Assessment for Dermal Products

ISO 10993-17 Toxicological Risk Assessment for Dermal Products Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

The ISO 10993-17 standard is a widely recognized and adopted international standard for the assessment of toxicological risk associated with dermal products. This standard is part of the larger ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

Relevant Standards:

International and National Standards:

The international standards governing this testing service are primarily developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations. These standards provide a framework for manufacturers to evaluate and test their products to ensure they meet the required safety and performance criteria.

In Turkey, the Turkish Standards Institution (TSE) has adopted the ISO 10993 series as national standards. The TSE Code is used as a reference point for the evaluation of biological compatibility of medical devices in Turkey.

Standard Development Organizations:

The standard development organizations involved in the creation and maintenance of these standards include:

These organizations work together to ensure that international standards are aligned with national requirements and that manufacturers can comply with regulatory requirements.

Standard Evolution and Update:

Standards evolve over time as new technologies emerge, and knowledge about the biological behavior of materials becomes more refined. The ISO 10993 series is regularly reviewed and updated to reflect changes in scientific understanding and technological advancements.

The most recent update to ISO 10993-17 (2020) introduced several significant changes, including revised testing protocols and additional requirements for dermal product evaluation.

Compliance Requirements:

Manufacturers of dermal products must comply with the relevant standards and regulations governing their products biological compatibility. Compliance with these standards is essential for ensuring that products meet required safety and performance criteria.

Consequences of Non-Compliance:

Failure to comply with ISO 10993-17 can result in significant consequences, including:

By choosing Eurolabs laboratory testing services, manufacturers can ensure their products meet the required standards for biological compatibility.

The ISO 10993-17 standard provides a comprehensive framework for evaluating dermal systemic toxicity. This standard is essential for ensuring that medical devices do not pose risks to human health through dermal exposure.

Consequences of Not Performing this Test:

Not performing the required testing can lead to:

Manufacturers must conduct the necessary testing to ensure their products comply with regulatory requirements and are safe for use on human skin.

Business and Technical Reasons for Conducting this Test:

The primary reasons for conducting the ISO 10993-17 test include:

By choosing Eurolabs laboratory testing services, manufacturers can ensure their products meet these essential criteria.

Quality Assurance and Quality Control Aspects:

Eurolab adheres to the highest standards of quality assurance and control in its laboratory testing services. Our commitment to quality ensures that test results are accurate, reliable, and compliant with regulatory requirements.

Risk Factors and Safety Implications:

The ISO 10993-17 standard evaluates dermal systemic toxicity through a series of tests designed to assess the potential risks associated with dermal exposure. Manufacturers must ensure their products meet these standards to mitigate potential risks.

Quality Assurance and Compliance Benefits:

By choosing Eurolabs laboratory testing services, manufacturers can:

Competitive Advantages and Market Positioning:

Conducting the ISO 10993-17 test provides significant competitive advantages for manufacturers, including:

Cost Savings and Efficiency Gains:

By choosing Eurolabs laboratory testing services, manufacturers can reduce costs and increase efficiency through:

Test results are also available in a format that is easily accessible for regulatory submissions.

Dermal Systemic Toxicity (DST) Testing Protocol:

The ISO 10993-17 standard requires manufacturers to conduct DST testing using guinea pigs. This testing protocol assesses the potential toxicity of dermal products through skin exposure and subsequent systemic absorption.

Eurolabs laboratory is equipped with state-of-the-art facilities and expert staff to ensure accurate and reliable test results.

Tests for Dermal Systemic Toxicity (DST) in the Guinea Pig:

The ISO 10993-17 standard requires manufacturers to conduct a series of tests designed to evaluate dermal systemic toxicity. These tests include:

By choosing Eurolabs laboratory testing services, manufacturers can ensure their products meet the required standards for biological compatibility.

Conclusion:

The ISO 10993-17 standard is a critical component of ensuring that dermal products are safe and reliable. Manufacturers must comply with this standard to mitigate potential risks associated with dermal exposure.

By choosing Eurolabs laboratory testing services, manufacturers can ensure their products meet the required standards for biological compatibility. Our commitment to quality assurance and control ensures accurate and reliable test results that meet regulatory requirements.

Next Steps:

To learn more about Eurolabs laboratory testing services or to discuss your specific needs, please contact us at insert contact information.