Design Completion Checklist for Electromechanical Devices


Product Name:                                 Model:                                      

Project Leader:                               Date:                                        



ITEM                           COMMENTS*
(Inside the Device)

 1)  Primary Grounding Connection -
 2)  Dead Metal Grounding -
 3)  Overcurrent Protection - 
 4)  Fuseholder Polarity -
 5)  2-Wire On/Off Switch - 
 6)  Abrasion, Strain Protect -
 7)  Circuit Spacing - 
 8)  Wiring Dress - 
 9)  Assembly, General -
10)  Hardware Tight -
11)  Cleanliness -
12)  Control Labels -
13)  Caution Labels -
14)  Interlocks; Labels -
15)  Barriers, Insulation -
16)  Moving Part Clearance -
17)  Fire Protection - 

HARDWARE

 1)  Device Specifications - 
 2)  Connectors & Cables -
 3)  Connector Propriety - 
 4)  Power Plug & Cord -
 5)  Cord Strain Relief -
 6)  General Construction -
 7)  Physical Stability -
 8)  Sharp, Hot, Moving, Pinching Parts -
 9)  Liquid & Dirt Protection -
10)  Corrosion Resistance -
11)  Maintainability - 
12)  Grounding Resistance Test -
13)  Grounding Leakage Current -
14)  Patient Circuit Leakage Current -
15)  Power Dielectric Test
16)  Patient Circuit Dielectric Test -






* The following abbreviations may be used in the comment column to save time.

U  = Unsatisfactory NA = Not Applicable
NI = Needs ImprovementS    = Satisfactory

Attach Additional sheets for comment explanation if necessary.

                               COMMENTS

17)  Transients Produced -
18)  Transient Immunity -
       Line, Signal, Static
19)  Battery Charge & Life Test -
20)  Line Voltage Tolerance -
21)  Temperature Tolerance Test -
22)  Humidity Tolerance Test -
23)  Shock Tolerance Test -
24)  Vibration, Ship. Test -
25)  Failure Modes & Effects Analysis -
26)  Performance Factors (add list for item being evaluated)
 -    
 -
 -
 -
27)  Normal Inputs -
28)  Abnormal Inputs -
29)  Sensor Failures -
30)  Output Device Failures -
31)  Power Loss & Restart -

LABELING

 1)  Fuse & Circuit Breaker Labels -
 2)  Control Labels -
 3)  Warning Labels -
 4)  Instruction Manual -
 5)  Maintenance Manual -

SOFTWARE

 1)  Specifications -
 2)  Annotated Code -
 3)  Flow Diagrams -
 4)  Displays -
 5)  Printouts -
 6)  Code Review -
 7)  Changeable -
 8)  Error Handling -
 9)  Operator Prompts - 
10)  Operator Error Prevention -
11)  Performance Tests (add list for item being evaluated)
 -
 -
 -
 -
12)  Normal Inputs -
13)  Abnormal Inputs -
14)  Sensor Failures -
15)  Output Device Failures -
16)  Power Loss & Restart -







                               COMMENTS


HUMAN FACTORS

 1)  Hardware (add list for item being evaluated)
 -
 -
 -
 -
 2)  Software (add list for item being evaluated)
 -
 -
 -
 -

REGULATORY

 1)  FDA 510(k) or IDE/PMA Submission
 -
 -
 -