1 Introduction
19
STANDARDS AND SAFETY REQUIREMENTS
The iVent
TM
201
meets or exceeds the following international standards:
EN/IEC 60601-1 Medical Electrical Equipment – General requirements
for safety
EN/IEC 60601-1-2 Medical Electrical Equipment - Part 1: General
requirements for safety 2. collateral standard:
Electromagnetic Compatibility - requirements and tests
EN/ IEC 60601-1-6 General requirements for basic safety and essential
performance - Collateral standard: Usability
EN/IEC 60601-2-12 Medical Electrical Equipment – Particular Requirements
for the Safety of Lung Ventilators - Critical Care
Ventilators
UL 60601-1 Medical Electrical Equipment, part1: General
Requirements for Safety
ASTM F1246 Standard Specification for Electrically Powered Home
Care Ventilation.
ISO 10651-2 Lung Ventilators for medical use – Particular
requirements for Home Care Ventilators
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