Validation of a Pressure Decay Leak Tester for a Medical Device

B

baezes

#1
How do I validate a pressure decay leak tester for a medical device?
We are currently performing an under water test at 8.75 psi and looking for bubbles.

Any suggestions or templates ?
 
Elsmar Forum Sponsor

mdurivage

Quite Involved in Discussions
#2
Re: Leak tester validation

What is your definition of a leak?

In the past, I used a sealed chamber and pulled a vacumm to determine if there was a leak. Worked pretty well, but was sensitive to changes in barametric pressure.

We would run known good units through as well as bad ones to ensure the system was functioning.

Hope that helps!
 
#3
How do I validate a pressure decay leak tester for a medical device?
We are currently performing an under water test at 8.75 psi and looking for bubbles.

Any suggestions or templates ?


I have the same problem now. I am trying to define the test parameters in a Uson Leak Tester. The Leak size has been defined as 30microm.

Were you able to validate your Pressure Decay Test Method?

Can you help me please?
 
Thread starter Similar threads Forum Replies Date
somashekar Application of parts with PSA (Pressure Sensitive Adhesive) - Is Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 8
S Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 5
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 1
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
B TMV - Selection of TM's for Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 9
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 5
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
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
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
J Requested Validation plan and reports Manufacturing and Related Processes 4
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1

Similar threads

Top Bottom