[Intl_DxMedPhys] QC for monitors for digital pathology

[David Clunie]

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Hi Mary Ellen

I don't think there are any (yet) that are specific to digital pathology applications.

As one example, if you look at the Barco MDPC-8127 510(k) equivalence determination
summary [1] none of the standards listed (including the FDA's TPA Guidance [2])
reference any specific QC standard. Nor does the EU IVDR DoC [3].

That said, the TPA guidance does reference (an older version [4] of) IDMS [5].

So this may be a case of being required to follow the manufacturers QC instructions
(like mammo displays under MQSA), but the user manual [6] is very light on this
subject (beyond specifying use of QAWeb for DICOM GSDF calibration, which is
not appropriate for digital pathology).

The TPA guidance says about QC for digital pathology systems in their entirety:

"Sponsors should provide information on the quality control procedures, including
frequency and testing methods to be performed by the laboratory technologists and/or
field engineers with associated quantitative action limits. Discussions of tests for
constancy should include discussions of the slide feeder and scanning mechanisms,
coverage of the entire tissue slide, the bar code reader, the light source, the imaging
sensor device, and the calibrations at the component and system level. A detailed
quality control manual should be provided."

but that does not mention the display explicitly (esp. when sourced separately rather
than being supplied by the slide scanner vendor).

AFAIK. AAPM TG322 on Color Displays in Medicine [7] is inactive, so perhaps was
subsumed into some other groups activities (like IEC TC 62/SC 62B/WG 51 [8]).
Perhaps someone on this list is/was involved and can clarify. You might be able
to get a draft copy of IEC 62563-3 and see if it applies.

The Digital Pathology Association (DPA) Regulatory and Standards Task Force [9] may
have some activities ongoing in this respect.

David

1. Food and Drug Administration. K203364 - Barco NV MDPC-8127 - 510(k) Substantial Equivalence Determination Decision Summary. 2021. Available from: https://urldefense.com/v3/__https://www.accessdata.fda.gov/cdrh_docs/reviews/K203364.pdf__;!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKM9xjrPsU$ 

2. Center for Devices and Radiological Health. Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff. FDA; 2016 Apr. Report No.: FDA-2015-D-0230. Available from: https://urldefense.com/v3/__https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-performance-assessment-digital-pathology-whole-slide-imaging-devices__;!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKM9ULxO8k$ 

3. https://urldefense.com/v3/__https://www.barco.com/en/support/docs/TDE12348__;!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKM6KSt7aI$ 

4. International Committee for Display Metrology (ICDM). Information Display Measurements Standard (IDMS) -  version 1.03. 2012.

5. International Committee for Display Metrology (ICDM). Information Display Measurements Standard (IDMS) -  version 1.3. Society for Information Display; 2025. Available from: https://urldefense.com/v3/__https://www.sid.org/Standards/ICDM*8271521-idmsv13__;Iw!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKMYqOIZpc$  doi:10.55410/HHXO3592

6. https://urldefense.com/v3/__https://www.barco.com/en/support/mdpc-8127/documentation?facets=*content*cq:tags*barco-dxp*support*tde*languages*en,*content*cq:tags*barco-dxp*support*tde*languages*ww__;Ly8vLy8vLy8vLy8vLy8!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKMAPLtgTs$ 

7. https://urldefense.com/v3/__https://www.aapm.org/org/structure/inactive_committee.asp?cc=TG322__;!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKMfR70uGc$ 

8. IEC 62563-3 ED1: Medical electrical equipment - Medical image display systems - Part 3: Evaluation methods for colour displays

9. https://urldefense.com/v3/__https://digitalpathologyassociation.org/digital-pathology-association-regulatory-committee__;!!KGKeukY!xhoxzwgxbwZZ2qzB2sidHahIY8mlxuVPd2VySpEqKdDnu0sxraxjw9icqRr8ubFT_bhZbtcn0ObSIMGuqPtyQx-RG_uCshKMUO4IJwg$ 

On 9/7/25 7:42 PM, Mary Ellen Jafari via Intl_dxmedphys_wd_osu_list wrote:

> Hello Listmembers, I am wondering if anyone is aware of any standards or QC for monitors used for digital pathology.  I have found some journal articles but no actual standards or specifications.
> 
> Another question is who, if anyone, at your facilities does QC testing on digital pathology monitors?
> 
> Thank you.
> 
> Mary Ellen Jafari, MS, DABR (D,N), MRSE, MRSO, FACR, FAAPM, CIIP
> 
> Chief Physicist and Regional Radiation Safety Officer
> 
> Kaiser Permanente
> 
> Southern California Permanente Medical Group Medical Imaging Technology and Informatics
> 
> 199 S. Los Robles Ave., Pasadena CA 91101
> 
> 626-430-1231 (office mobile)
> 
> Maryellen.Jafari at kp.org <mailto:Maryellen.Jafari at kp.org>