The Differences in Standards and Specifications of Dental Units in Different Countries and Regions

As core equipment in modern dental care, dental unit designs, manufacture, and use must adhere to strict international standards and regulations. However, significant differences exist between countries and regions regarding standards, regulatory frameworks, technical specifications, and product features. DYM Dental Factory share with you the differences in standards and regulations for dental units across different countries and regions, focusing on these standards, regulatory agencies, technical specifications, product features, and future trends.

1. Standards System and International Coordination

International Standards (ISO)
The ISO 7494 series of standards (such as ISO 7494-1:2018) developed by the International Organization for Standardization (ISO) are universal standards for dental equipment, covering device design, safety, and performance testing. While ISO standards are universally applicable, countries may adapt their implementation to meet local needs. For example, ISO 13485 (Quality Management System for Medical Devices) is widely adopted, but specific implementation details may vary from country to country. DYM Dental Factory already holds ISO 13485 and ISO 9001 certifications, has sold its independently produced dental units, dental air compressors, dental handpieces, dental suction units, and intraoral cameras in numerous countries, making it a trusted brand for dentists and distributors.

Regional Harmonized Standards
European Union (EN Standards): The EU aligns with international standards through harmonized standards (such as EN 1641:2009), emphasizing device compatibility and safety. The EU’s CE certification requires that devices comply with EN standards and pass the European Commission’s certification process. DYM Curing Light and Oral Camera have passed testing and obtained CE certification. They will subsequently conduct testing on other product categories to expand their market share. Dental Chair manufacturer
China (GB Standards): China adopts national standards such as GB/T 191-2008 (Packaging) and GB 9706.1-2007 (General Safety Requirements for Medical Electrical Equipment), which align with international standards. However, some technical parameters (such as electrical safety and sterilization requirements) may be more stringent.
United States (FDA): The U.S. Food and Drug Administration (FDA) has clear requirements for the classification of medical devices (such as Class II medical devices), requiring FDA registration and compliance with FDA 21 CFR Part 820 (Quality Management Systems).

Differences by Country/Region
Japan: Adopts JIS standards (such as JIS T 6010-1999), emphasizing equipment durability and safety.
Australia: Adopts Australian standards (AS/NZS 13485), which are highly consistent with ISO standards but require certification from the Australian Certification Council (ACCC).

2. Regulatory Agencies and Certification Process

Differences in Regulatory Agencies

China: The National Medical Products Administration (NMPA) is responsible for the registration and regulation of medical devices and requires NMPA certification. DYM Dental Factory, located in Foshan, Guangdong, has obtained relevant certificates, including the Guangdong Medical Device Registration Approval. Its product categories include dental chairs, oral camera, oil-free air compressors, high and low speed dental handpieces, dental burs and so on.dym honors

EU: The European Commission (EC) is responsible for CE certification, and devices must undergo evaluation by a Notified Body.

US: The FDA is responsible for the registration and post-market supervision of medical devices, and some devices require 510(k) or PMA (Pre-Market Approval) processes.

Different Certification Processes

EU: The CE certification process includes technical documentation preparation, Notified Body evaluation, and issuance of the CE mark.

China: NMPA certification requires submission of technical documentation, clinical trial data (if applicable), and quality management system documentation.

US: FDA registration requires submission of a 510(k) or PMA application, which involves clinical trials and quality management system audits.

3. Technical Parameters and Performance Requirements

Safety and Performance Standards
Electrical Safety: All countries require equipment to comply with the IEC 60601 series of standards (e.g., IEC 60601-1:2018), but specific test parameters (e.g., leakage current and insulation resistance) may vary slightly.
Disinfection and Safety: The EU requires equipment to have ozone disinfection capabilities, while China may prioritize physical disinfection (e.g., UV disinfection).

DYM dental disinfection chairs can provide ozone disinfection, making dental treatment safer. DYM Dental Factory also offers disinfection lamps for physical disinfection, providing enhanced service tailored to specific needs.

4. Product Features and Market Access

Market Access Differences
Developed countries: Equipment must obtain strict certifications (such as CE, FDA, and NMPA) and comply with local regulations (such as the EU’s RoHS Directive).
Developing countries: Some countries may have lower certification requirements for equipment, but approval by local regulatory agencies is still required.
Product Functionality Differences
High-end equipment: Brands from countries like Germany and Japan may offer digital features (such as 3D scanning and AI-assisted diagnosis), while basic equipment may only offer traditional functions.
Pricing and Features: Equipment in developed countries may include more comprehensive disinfection systems (such as automatic cleaning and sterilization), while equipment in developing countries may focus more on basic features.

DYM’s dental equipment targets the mid-to-high-end market. Its dental unit features multiple functions, such as an infrared and gravity-sensing water supply system, the rail-type chair frame , and a multi-function foot pedal, providing a unique and innovative experience for end customers.

5. Future Trends and Global Coordination

Global Standardization Trends
ISO Standard Promotion: The promotion of international standards (such as ISO 7494) will promote global device compatibility and interoperability.
Digitalization and Intelligence: The application of technologies such as AI-assisted diagnosis and telemedicine will further promote the development of intelligent devices.
Regional Coordination and Cooperation
International Organization Cooperation: Global standards coordination and unification are being promoted through platforms such as the International Organization for Standardization (ISO) and the International Medical Device Regulators Forum (IMDRF).
Regional Cooperation: Major economies such as the EU, China, and the US are promoting the coordination and mutual recognition of standards through bilateral or multilateral agreements.

6. Conclusion

Standards and specifications for dental unit units vary significantly across different countries and regions, primarily in terms of standards systems, regulatory agencies, technical specifications, and product features. While international standards (such as ISO) and harmonized standards (such as EN) help promote global consistency, differences in implementation persist across countries. In the future, with the advancement of global standardization and the strengthening of international cooperation, global standards and specifications for dental unit units will become more coordinated and unified, providing a more solid foundation for the development of global dental care.
DYM Dental Factory will closely follow future dental developments, independently develop dental equipment that is more tailored to dentists’ needs, and expand into the global market. Quality