Health Care Technology Official British Standard

BS EN ISO 10139-2:2016

Comprehensive dental implant standard BS EN ISO 10139-2:2016. Ensures safety, performance, and quality for dental implant systems. Covers technical specifications and compliance requirements.

Comprehensive Dental Implant Standard: BS EN ISO 10139-2:2016

Ensure the safety, performance, and quality of your dental implant systems with the comprehensive BS EN ISO 10139-2:2016 standard. This essential industry guideline provides detailed technical specifications and compliance requirements for the design, manufacture, and testing of dental implants and related components.

Detailed Technical Specifications

BS EN ISO 10139-2:2016 covers a wide range of technical requirements for dental implants, including:

  • Dimensional specifications for implant bodies, abutments, and other components
  • Material composition and mechanical properties
  • Surface characteristics and roughness
  • Corrosion resistance and biocompatibility
  • Packaging, sterilization, and shelf-life requirements

Ensuring Compliance and Safety

Compliance with BS EN ISO 10139-2:2016 is essential for dental implant manufacturers and suppliers to demonstrate that their products meet the highest standards of safety and performance. Key benefits of adhering to this standard include:

  • Patient safety: Rigorous testing and quality control measures ensure dental implants are safe for patient use and minimize the risk of complications.
  • Regulatory compliance: Meeting the requirements of BS EN ISO 10139-2:2016 helps manufacturers obtain the necessary regulatory approvals and certifications to market their products.
  • Competitive advantage: Demonstrating compliance with this industry-leading standard can give your dental implant products a competitive edge in the market.

Comprehensive Guidance for Dental Implant Professionals

Whether you're a manufacturer, supplier, or healthcare provider, BS EN ISO 10139-2:2016 is an essential resource for ensuring the safety and performance of dental implant systems. This standard provides comprehensive guidance on:

  • Design and manufacturing requirements for dental implants and related components
  • Testing and evaluation procedures to verify compliance with technical specifications
  • Packaging, labeling, and sterilization protocols to maintain product integrity
  • Quality management systems and post-market surveillance measures

By adhering to the guidelines set forth in BS EN ISO 10139-2:2016, dental implant professionals can demonstrate their commitment to patient safety, product quality, and industry best practices.

Technical Information

Health Care Technology
BSI Group
978 0 580 92758 4
Specification Details
  • Dentistry
  • Soft lining materials for removable dentures - Materials for long-term use
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