BS EN 60601-1-10:2008+A2:2021 - Professional Standards for Medical Electrical Equipment

BS EN 60601-1-10:2008+A2:2021 is a pivotal standard within the healthcare technology sector, providing essential guidance for the safety and performance requirements of medical electrical equipment and systems. This document is directly aligned with the international equivalent, IEC 60601-1-10:2007/AMD2:2020, ensuring that it meets global benchmarks for medical device design and implementation.

This standard is particularly crucial for manufacturers and stakeholders involved in the development of medical devices that employ a combination of electrical and mechanical systems. It offers comprehensive specifications covering risk management, essential performance guidelines, and the appropriate methodologies for testing electrical safety.

Key Features and Specifications

• ISBN: 978 0 580 97597 4
• Publication Date: August 29, 2008 (revised in 2021)
• Document Type: PDF and Hardcopy Formats Available
• Price: £306.00
• Focus Area: Health Care Technology

The amendment (A2:2021) serves to clarify and further define critical aspects of device design, maintenance, and operational safety. By adhering to these guidelines, organizations can not only enhance their compliance with regulatory standards but also improve the overall efficacy and safety of healthcare delivery systems. This serves to benefit both healthcare providers and patients alike, minimizing risks associated with electrical medical devices.

Who Should Use This Standard?

BS EN 60601-1-10:2008+A2:2021 is an invaluable resource for a broad spectrum of professionals, including:

• Manufacturers of medical electrical equipment
• Quality assurance and regulatory compliance teams
• Healthcare institutions and service providers
• Technical engineers and safety assessors

By implementing the standards set forth in this document, organizations can ensure that their medical devices are designed and operated to the highest safety standards, fostering a culture of excellence in healthcare delivery.

Purchasing Information

This important standard is available for purchase in both PDF and hardcopy formats, making it accessible to organizations of all sizes. For a price of £306.00, step into the future of healthcare compliance and enhance the safety of your medical electrical equipment with BS EN 60601-1-10:2008+A2:2021.