BS EN ISO 80601-2-85:2021 - Medical Electrical Equipment Standard

Introducing the BS EN ISO 80601-2-85:2021, a comprehensive standard that sets the benchmark for the basic safety and essential performance of cerebral tissue oximeter equipment. This standard is crucial for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of medical electrical equipment, specifically cerebral tissue oximeters.

Overview

The BS EN ISO 80601-2-85:2021 standard is a pivotal document that ensures the safety and performance of cerebral tissue oximeter equipment. Released on April 19, 2021, this standard is part of the ISO 80601 series, which focuses on medical electrical equipment. It provides detailed requirements that manufacturers must adhere to, ensuring that their products meet the highest safety and performance standards.

Key Features

• Standard Number: BS EN ISO 80601-2-85:2021
• Pages: 118
• ISBN: 978 0 539 02643 6
• Status: Standard

Importance of the Standard

Cerebral tissue oximeters are critical in monitoring the oxygenation of brain tissue, especially during surgical procedures and in intensive care settings. The BS EN ISO 80601-2-85:2021 standard ensures that these devices operate safely and effectively, minimizing risks to patients and enhancing clinical outcomes. By adhering to this standard, manufacturers can demonstrate their commitment to quality and safety, gaining trust from healthcare providers and patients alike.

Who Should Use This Standard?

This standard is essential for:

• Manufacturers: Ensures that their cerebral tissue oximeter equipment meets international safety and performance requirements.
• Healthcare Providers: Assists in selecting equipment that complies with the latest safety standards, ensuring patient safety and care quality.
• Regulatory Bodies: Provides a benchmark for evaluating the compliance of cerebral tissue oximeter equipment with international standards.

Benefits of Compliance

Compliance with the BS EN ISO 80601-2-85:2021 standard offers numerous benefits, including:

• Enhanced Safety: Reduces the risk of device-related incidents, ensuring patient safety.
• Improved Performance: Guarantees that devices perform reliably under various conditions, providing accurate and consistent results.
• Regulatory Approval: Facilitates the approval process for new devices, as compliance with international standards is often a prerequisite.
• Market Access: Opens doors to global markets, as many countries require compliance with international standards for medical devices.

Conclusion

The BS EN ISO 80601-2-85:2021 standard is an indispensable resource for anyone involved in the development, regulation, or use of cerebral tissue oximeter equipment. By ensuring compliance with this standard, stakeholders can enhance the safety and performance of these critical medical devices, ultimately improving patient outcomes and advancing healthcare quality worldwide.

For those committed to excellence in medical device manufacturing and healthcare delivery, the BS EN ISO 80601-2-85:2021 standard is a must-have document that provides the guidance needed to achieve the highest levels of safety and performance.

BS EN ISO 80601-2-85:2021

This standard BS EN ISO 80601-2-85:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

Clause 1 of the general standard applies, except as follows.

NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.