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21 CFR Subchapter J to IEC Comparison Table for Medical X-Ray Imaging Devices Mammography


Status: Active
Document ID: 100906

​Provides a standardized method of comparing 21 CFR Subchapter J standards with the comparable IEC Standards for manufactures who are attempting to use the IEC standard instead of the 21 CFR Standard. Includes a table that provides the relevant IEC requirement or testing procedure, so that state inspectors and medical physicists can test independently to confirm that the product conforms to the IEC standard.


Published Date: May.14.2020
Number of pages: 22
Document ID: 100906

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