Device Material or Material Leachate Pyrogenic Testing Evaluation Method

Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device. (Food and Drug Administration)

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Device Material or Material Leachate Pyrogenic Problem Evaluation Result

The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.

Device Material and Chemistry Evaluation Method

Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other…

Device Manufacturing Review Evaluation Method

Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records…

Device Manufacturing Process Problem Evaluation Result

Problems with a device that can be traced back to a problem in the manufacturing and/or production process.

Device Manufacturing Deficiency Evaluation Conclusion

The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of…

Device Manufacture Date

The date (and time) on which the medical device is made.