BS ISO 14117:2019

Comprehensive Healthcare Technology Standard

BS ISO 14117:2019 is the essential standard for healthcare technology professionals. This 146-page standard provides detailed requirements and testing methods for active implantable medical devices, ensuring safety and compliance.

Key Specifications:

- Covers active implantable medical devices, including cardiac pacemakers, defibrillators, nerve and muscle stimulators- Specifies design, manufacturing, and testing requirements to minimize electromagnetic interference (EMI) and ensure device functionality- Aligns with the latest ISO and IEC standards for medical device safety and performance- Applicable to both new device designs and existing devices undergoing modifications

Ensure Compliance and Patient Safety

Adhering to BS ISO 14117:2019 is crucial for healthcare organizations and medical device manufacturers. This standard helps you:• Mitigate risks of electromagnetic interference (EMI) that could disrupt device operation and compromise patient safety• Validate the electromagnetic compatibility (EMC) of active implantable devices through rigorous testing protocols• Demonstrate compliance with the essential requirements of the EU Medical Device Regulation (MDR) and other global regulations• Maintain the highest levels of quality, reliability, and safety for your active implantable medical devices

Comprehensive Guidance for Medical Professionals

BS ISO 14117:2019 provides extensive technical guidance across all aspects of active implantable device design, manufacturing, and testing, including:• Electromagnetic compatibility (EMC) requirements and test methods• Immunity to electromagnetic disturbances, including radio frequency (RF) fields, electrostatic discharge, and more• Emissions limits to prevent interference with other medical devices or equipment• Labeling, documentation, and risk management considerations• Validation and verification procedures to ensure ongoing complianceWhether you're a medical device engineer, regulatory affairs specialist, or healthcare provider, this standard is an invaluable resource for ensuring the safety and performance of active implantable technologies.