BS EN ISO 7405:2018

Comprehensive Healthcare Technology Standard

BS EN ISO 7405:2018 is the essential standard for evaluating the biocompatibility of medical devices used in dentistry. Developed by the International Organization for Standardization (ISO), this 52-page specification provides detailed requirements and test methods to ensure the safety and efficacy of dental materials and equipment.

Ensure Compliance and Patient Safety

This standard is a critical resource for medical device manufacturers, dental professionals, and regulatory bodies. It outlines the necessary steps to evaluate the biological response to dental materials, helping organizations:• Comply with the latest regulations and guidelines for medical device safety• Minimize risks of adverse reactions or complications for patients• Validate the biocompatibility of new or modified dental products

Detailed Technical Specifications

BS EN ISO 7405:2018 covers a wide range of technical requirements, including:• General principles for biological evaluation• Specific test methods for evaluating cytotoxicity, sensitization, irritation, and systemic toxicity• Guidance on selecting the appropriate biological tests• Procedures for preparing and handling test samples• Criteria for interpreting and reporting test resultsThe standard also provides recommendations for managing biological risks throughout the entire life cycle of a medical device - from design and development to production, distribution, and use.

Benefits of this Healthcare Technology Standard

• Ensures the safety and biocompatibility of dental materials and equipment• Aligns with the latest international regulations and best practices• Comprehensive technical specifications and test methods• Supports risk management and regulatory compliance• Applicable to a wide range of dental products and materialsWhether you're a manufacturer, researcher, or healthcare provider, BS EN ISO 7405:2018 is an essential resource for maintaining the highest standards of quality and patient safety in the dental industry.