Health Care Technology Official British Standard

BS EN IEC 80601-2-71:2018

Comprehensive medical device safety standard BS EN IEC 80601-2-71:2018. Ensures compliance for respiratory therapy equipment. Detailed technical specifications and benefits.

## BS EN IEC 80601-2-71:2018 - Respiratory Therapy Equipment Safety Standard### Comprehensive Medical Device Safety ComplianceBS EN IEC 80601-2-71:2018 is the essential safety standard for manufacturers of respiratory therapy equipment. This British Standard specifies the basic safety and essential performance requirements for electrically-powered respiratory therapy equipment, including:- Oxygen concentrators- Ventilators- Continuous positive airway pressure (CPAP) devices- Respiratory humidifiersBy adhering to the rigorous safety and performance criteria outlined in BS EN IEC 80601-2-71:2018, medical device manufacturers can ensure their respiratory products meet the highest levels of safety and reliability for patient use.### Detailed Technical SpecificationsBS EN IEC 80601-2-71:2018 provides comprehensive technical requirements covering all aspects of respiratory therapy equipment design and function, including:- Electrical safety- Mechanical safety- Software safety and security- Alarm systems- Usability and human factors- Environmental conditions- Electromagnetic compatibility (EMC)The standard also specifies testing methodologies to verify compliance with each technical requirement, giving manufacturers a clear roadmap for product development and certification.### Key Benefits of ComplianceImplementing the safety and performance criteria of BS EN IEC 80601-2-71:2018 provides medical device manufacturers with several important benefits:**Ensure Patient Safety**Rigorous safety standards help minimize the risk of patient injury or adverse events during respiratory therapy, protecting vulnerable users.**Reduce Liability Risks**Demonstrating compliance with this recognized safety standard can help mitigate legal and financial liabilities for manufacturers.**Facilitate Market Access**Meeting the requirements of BS EN IEC 80601-2-71:2018 is often a prerequisite for gaining regulatory approval and market access for respiratory therapy devices.**Enhance Competitive Positioning**Compliance with this leading safety standard can be a key differentiator, helping manufacturers build trust with healthcare providers and patients.### ConclusionBS EN IEC 80601-2-71:2018 is an essential standard for any manufacturer of respiratory therapy equipment. By adhering to its rigorous safety and performance criteria, medical device companies can ensure their products meet the highest levels of quality and reliability for patient use.

Technical Information

Health Care Technology
BSI Group
978 0 580 82583 5
Specification Details
  • Medical electrical equipment - Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
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