Duo™ Operating Instructions 0070-10-0603-01 5 - 3
Appendix Specifications
5.1.5 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Reviewer Guidance for Pre-market Notification Submission, November 1993 - draft
Guidance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
ISO 3744:1994 Acoustics - Determination of Sound Power Levels of
Noise Sources Using Sound Pressure
ANSI/AAMI/ISO 10993-
10:1995
Biological evaluation of medical devices-Part 10:
Tests for irritation and sensitization
ANSI/AAMI/ISO 10993-5 Biological evaluation of medical devices-Part 5:
Cytotoxicity
ANSI/AAMI/ISO 10993-1:1997 Biological evaluation of medical devices-Part 1:
Evaluation and testing
ANSI/AAMI SP-10:1992 Electronic or Automated Sphygmomanometers
EN 1041:1998 Information Supplied by the Manufacturer with
Medical Systems
EN 980:1996 + A1:1999
+ A2:2001
Graphical Symbols for Use in Labeling of Medical
Devices
IEC 878:1998 Graphical Symbols for Electrical Equipment in
Medical Practice
ISO 1000:1992 + A1:1998 SI units and recommendations for the use of their
multiples and of certain other units
To Next Page
Loading...
