Standards And Safety Requirements - GE iVent 201 Series User's Reference Manual

STANDARDS AND SAFETY REQUIREMENTS

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