ASTM E961 - 97(2021)

Overview of ASTM E961 - 97(2021)

The ASTM E961 - 97(2021) is a pivotal document within the realm of health care technology, offering comprehensive guidelines aimed at ensuring the safety, effectiveness, and quality of healthcare products and technologies. As a standard established by ASTM International, this document serves as a critical reference point for manufacturers, regulatory bodies, and healthcare providers alike. The document is updated periodically, with the latest version published in January 2021.

Key Specifications and Features

This standard outlines a series of essential requirements that facilitate the evaluation and implementation of health care technologies. The guidelines provided within this document cover a range of topics, including performance testing, risk management, and compliance with regulatory frameworks. With a focus on enhancing patient safety and improving healthcare outcomes, the ASTM E961 standard is integral in promoting best practices throughout the industry.

Applications and Importance

ASTM E961 is particularly crucial for organizations involved in the development and distribution of medical devices and health care technology services. By adhering to these standards, manufacturers can improve product reliability and address potential safety concerns before products reach the market. This proactive approach not only safeguards patients but also enhances the credibility and reputation of the companies involved.

Accessing the Standard

Available for £46.00, ASTM E961 - 97(2021) can be accessed in multiple formats, including PDF and hardcopy, making it convenient for users to integrate this critical information into their operational protocols. Given its comprehensive nature, obtaining a copy of this standard is essential for healthcare organizations striving for excellence in safety and efficacy.

Conclusion

In sum, ASTM E961 - 97(2021) stands as an authoritative standard in the field of health care technology, serving to unify practices across organizations and foster innovation while maintaining the highest standards of patient care and safety. Compliance with this standard is not just a regulatory requirement but a commitment to quality and excellence in health care.