BS EN ISO 80601-2-61:2019 - A Key Standard in Healthcare Technology

The BS EN ISO 80601-2-61:2019 standard is an essential document for professionals in the healthcare technology sector, specifically focusing on the safety and performance of medical devices that support or sustain life. This standard is part of the broader ISO 80601 series, which aims to ensure that medical electrical equipment operates safely and effectively.

Officially published on February 4, 2019, this standard is an identical adoption of the ISO 80601-2-61:2017 and lays down the necessary requirements and guidelines for developers, manufacturers, and healthcare providers involved in the design, development, and use of medical devices intended for clinical applications.

Scope and Importance

BS EN ISO 80601-2-61:2019 specifically addresses various crucial aspects of medical electrical equipment, including:

• General safety requirements that ensure patient and operator protection.
• Performance criteria to ascertain the reliability and validity of medical devices.
• Risk management processes to identify, assess, and mitigate potential hazards associated with the device.

By adhering to these guidelines, organizations can enhance patient safety, reduce liability, and improve overall healthcare outcomes.

Who Should Use This Standard

This standard is indispensable for various stakeholders, including:

• Manufacturers of medical devices
• Regulatory bodies overseeing medical device compliance
• Healthcare facilities and providers utilizing medical technology
• Researchers and developers involved in medical technology innovations

Implementing the principles set out in BS EN ISO 80601-2-61:2019 not only helps in complying with regulatory requirements but also fosters innovation, ensuring that new products are equipped to meet the intricate needs of healthcare systems.

How to Purchase

The BS EN ISO 80601-2-61:2019 is available in both PDF and hardcopy formats for a price of £330.00. Acquiring this standard is a pivotal step for any organization committed to excellence within the healthcare technology sector.

Investing in BS EN ISO 80601-2-61:2019 not only positions your organization as a leader in quality and safety within medical technology but also demonstrates a commitment to innovation and compliance in a rapidly evolving market.