Glossary Term
ISO 80601 (Medical Electrical Equipment – Particular Requirements for Medical Devices)
Definition
ISO 80601 is a series of international standards that outlines particular safety and performance requirements for specific types of medical electrical equipment, such as ventilators, respiratory devices, and anesthesia machines. It complements ISO 60601 by addressing specialized functionality and risk considerations unique to these devices.
Relevance to the MedTech Industry
ISO 80601 ensures that specialized medical electrical equipment used in critical and respiratory care settings meets stringent safety, performance, and reliability standards. It reduces risks to patients and healthcare providers, ensuring that these devices function effectively under real-world clinical conditions.
Additional Information & Related Terms
Key Standards in the ISO 80601 Series
ISO 80601-2-12: Critical Care Ventilators
Specifies requirements for ventilators used in intensive care units (ICUs).
ISO 80601-2-13: Anesthesia Workstations
Addresses safety and performance criteria for anesthesia delivery systems.
ISO 80601-2-70: Sleep Apnea Therapy Devices
Provides requirements for continuous positive airway pressure (CPAP) and other devices for sleep-disordered breathing.
ISO 80601-2-72: Airway Clearance Devices
Covers devices that assist with clearing respiratory airways.
ISO 80601-2-74: Oxygen Concentrators
Details requirements for devices used to deliver oxygen therapy.
Related Terms
ISO 60601: General requirements for medical electrical equipment, forming the basis for ISO 80601 standards.
Risk Management (ISO 14971): Integrated into ISO 80601 to identify and mitigate risks in specialized medical devices.
Electromagnetic Compatibility (EMC): Ensured under IEC 60601-1-2, critical for devices covered by ISO 80601.
Post-Market Surveillance (PMS): Supports ongoing monitoring of device performance in real-world conditions.