BS EN ISO 12870:2018 - Quality Assurance in Health Care Technology

The BS EN ISO 12870:2018 standard is designed to enhance the reliability and quality of health care technology. As an identical implementation of ISO 12870:2016, this British Standard serves as a crucial guide for organizations committed to improving the safety and efficacy of medical devices.

Overview and Importance

Health care technology encompasses a wide range of devices and processes that are essential in delivering high-quality health care. The BS EN ISO 12870:2018 standard aims to establish a framework for the quality assurance of these technologies, ensuring they perform effectively without compromising patient safety. This standard outlines rigorous procedures aimed at minimizing risks associated with medical devices, thereby supporting health care professionals in their critical roles.

What You Will Find Inside

This standard provides detailed methodologies for assessing and validating health care technologies, focusing on the following areas:

• Quality Management Systems: Guidance on establishing effective quality management processes that comply with international standards.
• Risk Management: Strategies to identify, assess, and mitigate risks associated with the usage of health care technology.
• Clinical Evaluation: Frameworks for clinical evaluations that ensure technologies meet necessary performance requirements.
• Regulatory Compliance: Insights into maintaining compliance with regulatory demands and ensuring ongoing safety for users and patients.

Who Should Use This Standard?

The BS EN ISO 12870:2018 standard is essential for organizations involved in the development, manufacturing, and regulatory oversight of medical technology. This includes:

• Manufacturers of medical devices
• Health care service providers
• Regulatory bodies
• Quality assurance professionals
• Clinical researchers

Benefits of Compliance

By adhering to the guidelines of BS EN ISO 12870:2018, organizations can achieve significant benefits, including:

• Improved patient safety through rigorous testing and validation processes.
• Enhanced marketability of medical devices by demonstrating compliance with internationally recognized standards.
• Greater operational efficiency and reduced costs associated with non-compliance and product recalls.

Invest in Your Quality Standards

At a price of £258.00, the BS EN ISO 12870:2018 standard is a vital investment in your organization’s commitment to quality health care technology. Equip your team with the knowledge and tools necessary to navigate complex compliance landscapes and enhance your reputation in the health care sector.

Your commitment to quality assurance starts here—ensure you stay at the forefront of health care technology with BS EN ISO 12870:2018.