Regulatory and Agency Standards
Testing and evaluation of the HT70 Ventilator has been conducted in
compliance with the following voluntary standards:
ASTM F 1100-90:1997 Standard Specifications for Ventilators Intended for
Critical Care Use
ASTM F 1246-91:2005 Standard Specifications for Electrically Powered
Home Care Ventilators – Part 1: Positive-Pressure Ventilators and Ventilator
Circuits
IEC 60068-2-6:2008 Environmental Testing- Part 2: Tests- Test FE:
Vibration (Sinusoidal)
IEC 60068-2-27:2008 Environmental Testing- Part 2: Tests- Test EA and
Guidance: Shock
IEC 68-2-34:1973 Environmental Testing- Part 2: Tests- Test Fd: Random
Vibration Wide Band – General Requirements
IEC 60601-2-12:2001 Particular Requirements for the Safety of Lung
Ventilators for Medical Use
IEC 60601-1:1988 (+A1:1991 +A2:1995) Medical Electrical Equipment – Part
1: General Requirements for Safety
IEC 60601-1-1:2000 Medical Electrical Equipment, Collateral Standard:
Safety Requirements for Medical Electrical Systems
IEC 60601-1-2:2001 Medical Electrical Equipment, Collateral Standard:
Electromagnetic Compatibility- Requirements and Tests
IEC 60601-1-4:2000 Medical Electrical Equipment, Collateral Standard:
Programmable Electrical Medical Systems
EC 60601-1-6:2004 Medical Electrical Equipment, Collateral Standard:
Usability
IEC 60601-1-8:2006 Medical Electrical Equipment, Collateral Standard:
General Requirements, Tests, and Guidance for Alarm Systems in Medical
Electrical Equipment and Medical Electrical Systems
MIL-STD-810E Test Method Standard for Environmental Engineering
Considerations and Laboratory Tests
*Call for availability
OPRHT70 A0310
9-10
9
Specifications
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