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EN ISO 15223-1 Symbols for use in the labeling of medical devices.
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A1 Information to be supplied by the manufacturer of medical
devices
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EN 60529 Degrees of protection provided by enclosures (IP Code)
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EN 61326-1 EMC Requirements for Electrical Equipment.
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IE A1 Medical Device Software – Software life cycle processes.
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IEC 62366- 1– Part1: Application of Usability Engineering to Medical
Devices
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EN 62366 - Application of Usability Engineering to Medical Devices
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ANSI/AAMI ST55
1.2.1
And in consideration with:
FDA QSR 21 CFR part 820 & part 11
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Summary of Contents for AMS10-120-T
Page 2: ......
Page 4: ...https www tuttnauerusa com...
Page 16: ...1 10 Device Specifications 1 10 1 Device Overall Dimensions Page 9...
Page 55: ...Note For the results of the cycle see description in section 8 5 Page 48...
Page 66: ...Press to receive the entire printout of the selected cycle history Page 59...
Page 85: ...Page 78...