ASTM D4196 - 05(2019) Overview

The ASTM D4196 - 05(2019) is a pivotal standard in the realm of health care technology, offering critical guidelines and specifications for the evaluation of certain healthcare products. Updated in November 2019, this version provides enhanced clarity and precision regarding the performance criteria necessary for various medical technologies. The standard is a key resource for manufacturers, regulators, and healthcare professionals, ensuring that medical devices and technologies meet essential safety and efficacy requirements.

Purpose and Scope

This standard aims to ascertain the quality and performance of health care devices by offering a systematic approach to their evaluation. It establishes a comprehensive framework for the testing of medical products, considering multiple factors such as biocompatibility, functionality, and usability. By adhering to ASTM D4196, organizations can ensure compliance with regulatory mandates and bolster the reliability of their healthcare technologies.

Key Features

• Comprehensive Testing Protocols: The standard includes detailed methodologies for conducting thorough assessments of medical devices, ensuring consistent results.
• Safety and Efficacy Assurance: By following the prescribed protocols, manufacturers can verify that their products are safe and effective for patient use.
• Adaptability: The guidelines provided are designed to be applicable to a wide range of healthcare technologies, facilitating their integration into various product lines.
• Regulatory Compliance: Using ASTM D4196 helps organizations align with international regulatory frameworks, streamlining the approval process for new products.

Benefits of Compliance

By adhering to the ASTM D4196 - 05(2019) standards, stakeholders in the healthcare sector can achieve greater assurance of quality and performance in their medical technologies. Compliance aids in minimizing risks associated with medical devices, ultimately enhancing patient safety and confidence. Furthermore, aligning with this standard can significantly improve market competitiveness, as it positions manufacturers as providers of high-quality, reliable healthcare solutions.

Availability

The ASTM D4196 - 05(2019) document is available for purchase at a competitive price of £59.00. It can be accessed in both PDF and hardcopy formats, making it accessible for a range of needs and preferences.

Conclusion

In conclusion, the ASTM D4196 - 05(2019) is an essential standard for those involved in the development and evaluation of healthcare technologies. Its rigorous requirements help ensure that products meet the highest standards of safety and efficacy, ultimately benefiting patient care across the globe.