What testing would you run to determine if a device is "Clean"?

rwend07

Involved In Discussions
#1
What testing would you all run to determine if a device is "clean"? What are acceptable levels during those tests for a clean device?

We have asked our regulatory consultants this question, and got a bit of flaky answers. I also haven't seen anywhere that really defines what "clean" is/means.

Take initial bioburden during biocompatibility testing and use that as a baseline for future bioburden levels? Same thing for particulates?
 
Elsmar Forum Sponsor

JeantheBigone

Quite Involved in Discussions
#2
Re: "Clean" device measurements

The type of testing depends on the type of residue expected.

ASTM F2847 suggested testing methods for different types of residue, and there are helpful resources here:

http://www.campoly.com/files/8913/6..._Workshop_on_Reprocessing_Medical_Devices.pdf

and here:

https://www.rms-foundation.ch/fileadmin/dokumente/ASTM_workshop_on_cleanliness.pdf

The first link shows a chart for the different testing methods for various types of residue.

Establishing acceptable cleanliness limits is left to the manufacturer and can as you said rely on biocompatibility testing. What is important is that the limits are justified.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: "Clean" device measurements

It all depends on the intended use.

It's up to you to decide what's important and how is "clean" defined. Then you can set limits and derive test methods from what you're looking for.

Biocompatibility should be tested (if testing is necessary) on devices as they're serially manufactured. If bioburden is not important for the intended use and the manufacturing environment doesn't particularly attenuate bioburden, this is how biocompatibility should be tested (on "dirty" devices). If the device passes biocompatibility testing in its "natural" state there is no special reason to make it / keep it cleaner than as-tested, nor to actively monitor its cleanliness.

If bioburden is of importance for the intended use there are specific published standards which include test methods. The pass/fail criteria would, however, depend on the specific intended use, ie on what clinically matters.

Particulate contamination is tricky and I'm not aware of a wide consensus on acceptance criteria, even within specific application fields such as drug delivery. Talk to clinical opinion leaders in your specific field to get a feel for the requirements.

I wouldn't whole-heartedly support testing for residues that don't make a difference for the intended use, even if they're expected. Gross contamination would be obvious, and besides, it should be addressed through proper design & process controls rather than through testing (QA rather than QC).
 
Last edited:

rwend07

Involved In Discussions
#4
Re: What testing would you all run to determine if a device is "clean"?

Great, thank you both for the thoughtful responses.
 

normzone

Trusted Information Resource
#5
Re: What testing would you all run to determine if a device is "clean"?

Lick my finger, rub it on the product, lick my finger again.

Sorry, rough day. I did determine exactly what kind of soft drink had been spilled into a customer's computer returned "under warranty" in that manner once.

Customer Service report noted " Dr. Pepper " as the cause of failure.
 
Thread starter Similar threads Forum Replies Date
G Success Run testing - Confidence Levels Reliability Analysis - Predictions, Testing and Standards 7
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 2
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 2
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Workplace Drug Testing in 2020 Misc. Quality Assurance and Business Systems Related Topics 9
W ASTM F1929 dye penetration test - validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 2
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 7
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
T Spirometer - Pulmonary Function Testing - ATS/ERS:2005 EU Medical Device Regulations 5
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
F Proficiency Testing for ISO 17025: AC Current Ranges ISO 17025 related Discussions 1
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
Manix Supplied Steel Material Testing Norms and Requirements Supplier Quality Assurance and other Supplier Issues 1
M Reliability Testing - Weibull Analysis Help Reliability Analysis - Predictions, Testing and Standards 4
M Routine testing of medical electrical systems - What specific electrical safety tests should be performed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Similar threads


















































Top Bottom