Specifications Appendix
6 - 4 0070-10-0666-01 Trio™ Operating Instructions
6.1.4 Environmental / EMC
6.1.5 United States Food and Drug Administration Documents
Reviewer Guidance for Pre-market Notification Submission, November 1993 - draft
Guidance
Non-Invasive Blood Pressure (NIBP) Monitor Guidance, March 10, 1997
Non-Invasive Pulse Oximeter General Guidance, draft, September 7, 1992
Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm), November 5,
1998
IEC 60601-1-2:2001/ Medical Electrical Equipment - Part 1-2: EN
60601-1-2:2001 General Requirements for
Safety: EMC Requirements and Tests
IEC 68-2-6:(1982) and A1(1983) and
A2(1985)
Basic Environmental Test Procedures Part 2:
Vibration
IEC 68-2-27:1987 Basic Environmental Test Procedures Part 2:
Shock
IEC 68-2-37:1973 & A1:1983 Basic Environmental Test Procedures Part 2:
Random Vibration - Wide Band
IEC 529:1989 Degrees of Protection Provided by
Enclosures (IP Code)
ISTA: 1998 Procedure 1A Pre-Shipment Test Procedures
ECRI PB-296892:1979 (for Drop and Impact
requirements)
Development of Environmental Test Methods
for Non-Implantable Devices (Class 3
device)
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