BS EN ISO 28399:2021 - Dentistry. External Tooth Bleaching Products

Welcome to the world of dental excellence with the BS EN ISO 28399:2021 standard, a comprehensive guide dedicated to external tooth bleaching products. Released on April 12, 2021, this standard is an essential resource for dental professionals, manufacturers, and regulatory bodies who are committed to ensuring the highest quality and safety in tooth bleaching products.

Overview of BS EN ISO 28399:2021

The BS EN ISO 28399:2021 standard is a meticulously crafted document that spans 32 pages, providing detailed guidelines and specifications for external tooth bleaching products. It is a part of the ISO (International Organization for Standardization) series, which is recognized globally for setting benchmarks in quality and safety across various industries.

With the ISBN 978 0 539 15128 2, this standard is a testament to the rigorous processes involved in the development of dental products that are both effective and safe for consumer use. The status of this document as a standard underscores its importance and relevance in the field of dentistry.

Key Features and Benefits

The BS EN ISO 28399:2021 standard offers a multitude of features and benefits that make it an indispensable tool for anyone involved in the production or regulation of tooth bleaching products:

• Comprehensive Guidelines: This standard provides a thorough framework for the formulation, testing, and labeling of external tooth bleaching products, ensuring they meet the highest safety and efficacy standards.
• Global Recognition: As part of the ISO series, this standard is recognized and respected worldwide, facilitating international trade and compliance.
• Consumer Safety: By adhering to the guidelines set forth in this standard, manufacturers can ensure that their products are safe for consumer use, minimizing the risk of adverse effects.
• Quality Assurance: The standard outlines quality control measures that help maintain consistency and reliability in product performance.
• Regulatory Compliance: Compliance with this standard can aid in meeting regulatory requirements in various regions, simplifying the approval process for new products.

Who Should Use This Standard?

The BS EN ISO 28399:2021 standard is designed for a wide range of stakeholders in the dental industry, including:

• Dental Product Manufacturers: Companies involved in the production of tooth bleaching products can use this standard to guide their product development and quality assurance processes.
• Regulatory Bodies: Government and regulatory agencies can reference this standard when evaluating the safety and efficacy of tooth bleaching products.
• Dentists and Dental Professionals: Practitioners can rely on this standard to recommend safe and effective products to their patients.
• Research and Development Teams: R&D professionals can use the guidelines to innovate and improve existing tooth bleaching technologies.

Why Choose BS EN ISO 28399:2021?

Choosing the BS EN ISO 28399:2021 standard means choosing a commitment to excellence in dental care. This standard not only ensures that products are safe and effective but also promotes innovation and continuous improvement in the field of dentistry. By adhering to these guidelines, stakeholders can contribute to the advancement of dental health and the enhancement of consumer trust in tooth bleaching products.

Conclusion

In conclusion, the BS EN ISO 28399:2021 standard is an invaluable resource for anyone involved in the development, regulation, or use of external tooth bleaching products. Its comprehensive guidelines, global recognition, and focus on safety and quality make it a cornerstone of modern dental practice. Embrace this standard to ensure that your products meet the highest standards of excellence and contribute to the well-being of consumers worldwide.

BS EN ISO 28399:2021

This standard BS EN ISO 28399:2021 Dentistry. External tooth bleaching products is classified in these ICS categories:

• 97.170 Body care equipment
• 71.100.70 Cosmetics. Toiletries

This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use.

This document is not applicable to tooth bleaching products:

• specified in ISO 11609;

• intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;

• auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.

This document does not specify biological safety aspects of tooth bleaching products.

NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.

This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use.

This document is not applicable to tooth bleaching products:

• specified in ISO 11609;

• intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;

• auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.

This document does not specify biological safety aspects of tooth bleaching products.

NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.