Health Care Technology Official British Standard

BS EN ISO 4049:2019

Comprehensive standard for polymer-based restorative materials in healthcare. Ensures quality, safety, and performance for dental applications. Compliance benefits for healthcare providers.

Comprehensive Standard for Polymer-Based Restorative Materials

The BS EN ISO 4049:2019 is the definitive standard for polymer-based restorative materials used in healthcare applications, particularly in the dental industry. This standard, identical to ISO 4049:2019, provides detailed specifications and requirements to ensure the quality, safety, and performance of these critical materials.

Ensuring Quality and Reliability

- Outlines physical, chemical, and biological requirements for polymer-based restorative materials- Specifies test methods to evaluate key properties such as flexural strength, water sorption, and radiopacity- Ensures consistent quality and reliability for dental fillings, crowns, bridges, and other restorative applications

Promoting Patient Safety

- Establishes biocompatibility and cytotoxicity requirements to minimize potential health risks- Mandates thorough testing and evaluation of materials to protect patient wellbeing- Supports the use of safe, high-quality materials in critical healthcare applications

Enhancing Clinical Performance

- Defines performance criteria to optimize the longevity and effectiveness of restorative treatments- Ensures materials meet stringent standards for mechanical properties, color stability, and wear resistance- Helps healthcare providers deliver durable, long-lasting restorations for their patients

Driving Innovation and Advancement

- Provides a framework for the development and evaluation of new polymer-based restorative materials- Encourages continuous improvement and innovation within the healthcare technology industry- Supports the introduction of advanced materials that enhance patient outcomes and experiences

Compliance Benefits for Healthcare Providers

By adhering to the requirements outlined in BS EN ISO 4049:2019, healthcare providers can:- Ensure the use of high-quality, safe, and effective polymer-based restorative materials- Demonstrate compliance with relevant regulations and standards for healthcare technology- Differentiate their services and build trust with patients through the use of certified materials- Reduce the risk of complications or failures associated with substandard restorative materials- Stay at the forefront of advancements in polymer-based restorative technology

Conclusion

The BS EN ISO 4049:2019 standard is an essential reference for healthcare providers, material manufacturers, and regulatory bodies. By establishing comprehensive requirements for polymer-based restorative materials, this standard helps to promote patient safety, enhance clinical performance, and drive innovation in the healthcare technology industry.

Technical Information

Health Care Technology
BSI Group
978 0 580 51421 0
Specification Details
  • Dentistry
  • Polymer-based restorative materials
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