Normas Reguladoras E Institucionales - Newport HT70 Manual De Instrucciones

9
Especificaciones

Normas reguladoras e institucionales

Las pruebas y evaluaciones del respirador HT70 se han realizado en cumplimiento
de las siguientes normas voluntarias:
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
CSA 22.2-601.1 Medical Electrical Equipment - Part 1-1: General Requirements for
Safety
5-1
OPR360U A0509
9-10
OPRHT70-2-ES Rev. B 10-2013