DD ISO/TS 10993-20:2006 - Comprehensive Guidance for Biological Evaluation

The DD ISO/TS 10993-20:2006 standard provides vital insights into the biological evaluation of medical devices, addressing biocompatibility testing protocols essential for ensuring safety in healthcare technology. Published on September 29, 2006, this guideline represents an identical adoption of the ISO standard, emphasizing its global significance.

With an ISBN of 0 580 49228 1, this document serves as an authoritative reference point for professionals involved in the development, testing, and regulatory compliance of medical devices. Costing £220.00, it is an essential investment for manufacturers, regulatory professionals, and quality assurance experts focused on patient safety and compliance with rigorous industry standards.

Key Specifications

• Category: Health Care Technology
• Standard Type: Technical Specification
• ISBN: 0 580 49228 1
• Publication Date: September 29, 2006
• Format: Available in both PDF and hardcopy

Importance of Biological Evaluation

In the context of increasing scrutiny over medical devices and their impact on human health, the biological evaluation is a necessity that cannot be overlooked. DD ISO/TS 10993-20:2006 provides a framework for assessing risks associated with the biological interactions of device materials, which is critical in the pre-market phase. The standard outlines methodologies for risk assessment, ensuring that all devices meet the stringent safety requirements dictated by regulatory bodies.

Who Should Use This Standard?

This technical specification is particularly beneficial for:

• Device manufacturers looking to align their products with international safety standards.
• Quality assurance teams tasked with overseeing compliance and risk management.
• Regulatory affairs personnel engaged in submitting documentation for market approvals.

Conclusion

Investing in the DD ISO/TS 10993-20:2006 is a strategic decision that enhances the credibility of medical device manufacturers while facilitating compliance with global regulations. The standard not only aids in mitigating risks but also supports the advancement of healthcare technology by ensuring that devices do not adversely affect patients. Secure your copy today and take a significant step toward safeguarding healthcare outcomes.