BS EN IEC 60601-2-21:2021+A1:2023 - Medical Electrical Equipment Standard

Standard Number: BS EN IEC 60601-2-21:2021+A1:2023

Pages: 46

Released: 2024-01-10

ISBN: 978 0 539 16772 6

Name: Medical electrical equipment Particular requirements for the basic safety and essential performance of infant radiant warmers

Status: Standard

Overview

Ensure the highest level of safety and performance for infant radiant warmers with the BS EN IEC 60601-2-21:2021+A1:2023 standard. This comprehensive document outlines the essential requirements and guidelines for the basic safety and performance of medical electrical equipment, specifically designed for infant radiant warmers. Released on January 10, 2024, this standard is a must-have for manufacturers, healthcare providers, and regulatory bodies committed to maintaining the highest standards in neonatal care.

Key Features

• Comprehensive Coverage: Spanning 46 pages, this standard provides detailed requirements and guidelines to ensure the safety and performance of infant radiant warmers.
• Up-to-Date Information: Incorporates the latest amendments and updates, including the 2023 amendment, to ensure compliance with current safety and performance standards.
• ISBN: 978 0 539 16772 6, ensuring easy reference and cataloging.
• Release Date: January 10, 2024, ensuring the most current and relevant information is included.

Why Choose BS EN IEC 60601-2-21:2021+A1:2023?

Infant radiant warmers are critical in providing the necessary warmth to newborns, especially those in neonatal intensive care units (NICUs). Ensuring these devices meet stringent safety and performance standards is paramount. The BS EN IEC 60601-2-21:2021+A1:2023 standard offers:

• Enhanced Safety: Detailed safety requirements to protect both infants and healthcare providers.
• Optimal Performance: Guidelines to ensure the equipment performs effectively, providing consistent and reliable warmth to infants.
• Regulatory Compliance: Helps manufacturers and healthcare facilities comply with international safety and performance regulations.
• Quality Assurance: Ensures that the equipment meets high-quality standards, reducing the risk of malfunctions and enhancing patient care.

Who Should Use This Standard?

This standard is essential for a wide range of stakeholders in the healthcare and medical device industries, including:

• Manufacturers: Ensure your infant radiant warmers meet the highest safety and performance standards.
• Healthcare Providers: Maintain the highest level of care for newborns by using equipment that complies with this standard.
• Regulatory Bodies: Ensure compliance with international safety and performance regulations.
• Quality Assurance Professionals: Implement rigorous quality control measures to ensure equipment reliability and safety.

Detailed Content

The BS EN IEC 60601-2-21:2021+A1:2023 standard covers a wide range of topics, including but not limited to:

• General Requirements: Basic safety and essential performance requirements for infant radiant warmers.
• Mechanical Safety: Guidelines to ensure the mechanical safety of the equipment.
• Electrical Safety: Requirements for electrical safety to prevent hazards such as electric shock.
• Thermal Safety: Standards to ensure the equipment provides consistent and safe thermal output.
• Performance Testing: Procedures for testing the performance of infant radiant warmers to ensure they meet the required standards.
• Maintenance and Servicing: Guidelines for the proper maintenance and servicing of the equipment to ensure long-term reliability and safety.

Benefits of Compliance

Adhering to the BS EN IEC 60601-2-21:2021+A1:2023 standard offers numerous benefits, including:

• Improved Patient Safety: Ensures that infant radiant warmers are safe for use, reducing the risk of accidents and injuries.
• Enhanced Equipment Performance: Guarantees that the equipment performs effectively, providing the necessary warmth to newborns.
• Regulatory Approval: Facilitates compliance with international regulations, making it easier to gain regulatory approval for your products.
• Market Competitiveness: Demonstrates your commitment to quality and safety, enhancing your reputation and competitiveness in the market.

Conclusion

The BS EN IEC 60601-2-21:2021+A1:2023 standard is an essential resource for anyone involved in the design, manufacture, regulation, or use of infant radiant warmers. By adhering to this standard, you can ensure the highest levels of safety and performance, providing peace of mind to healthcare providers and the best possible care to newborns. Don't compromise on quality and safety—make sure your equipment meets the stringent requirements outlined in this comprehensive standard.

BS EN IEC 60601-2-21:2021+A1:2023

This standard BS EN IEC 60601-2-21:2021+A1:2023 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment