Biocompatibility Testing - Component Level or Assembled Medical Device?

#1
Hi Covers, I've been struggling to find a right answer for this question.

We are manufacturing a Class IIa non-sterile device. The device is made up of approximately 6 components, out of which 2 are patient-contacting. To make the complete device, these components are assembled with medical UV-cure adhesive. The cured adhesive would not come in direct contact with the patient.

For biocompatibility testing, do we send in the patient-contacting components in the final finished form (injection and compression molded), or do we send the assembled device, from which the test lab would remove the required components for testing?

Thanks in advance!

Keith
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Hi Covers, I've been struggling to find a right answer for this question.

We are manufacturing a Class IIa non-sterile device. The device is made up of approximately 6 components, out of which 2 are patient-contacting. To make the complete device, these components are assembled with medical UV-cure adhesive. The cured adhesive would not come in direct contact with the patient.

For biocompatibility testing, do we send in the patient-contacting components in the final finished form (injection and compression molded), or do we send the assembled device, from which the test lab would remove the required components for testing?

Thanks in advance!

Keith

Hi Keith,

Just curious....would it be feasible to send both versions to ensure you've covered everything?
 

yodon

Staff member
Super Moderator
#3
I would suggest you talk to the lab and get their inputs. My understanding is that they take your thing and soak it in various solutions so if you need to exclude the non-patient-contacting parts, you'd have to have some kind of strategy and they should be able to work with you on that. The test labs require that you send production components since production processes may have an effect. Oh, and there are requirements for the amount of material provided. Again, they should be able to work with you on all that.
 

Mark Meer

Trusted Information Resource
#4
In my view you have 2 options:

1. Send the 2 patient-contacting materials (without the UV-cure adhesive), and then document a justification as to why the presence of the UV-cure adhesive does not affect the results of the testing. This may be difficult to do, unless there is some precedent (e.g. research, comparable devices on the market) or some other evidence you can point to.

2. Either send them the components with the UV-cure adhesive attached and instruct them to remove it prior to testing, or remove it yourself prior to sending to the test lab and document somewhere that this was done in the samples sent to the lab.

I also agree with yodon that it's probably a good idea to ask the lab's input.

MM.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Assuming that we are talking about ISO 10993-1:2009 (and derivatives) -

For some reason most people seem to jump right to the test table and the tests they think apply, then dive into the implementation details, while the standard speaks a lot and in detail about "an evaluation" (not necessarily testing) and the risk management process context. Sadly this seems to be aligned with current test labs practice - they seem just too happy to get on to testing with minimally "ticking the boxes" that they have to according to the standard. It's sad because their original role in the standard is one of thought, analysis, insight and guidance.

Whatever testing is eventually carried out, it should be based on a thorough and wide analysis and consideration of all relevant available information. This analysis should be carried out by knowledgeable, qualified and experienced experts (the most trivial interpretation of which being the lab's expert toxicologists). As part of this process all the above issues and options should be taken into account and the optimal path forward should be recommended.

All the above should be then elaborated in the biological evaluation report.
 

Mark Meer

Trusted Information Resource
#6
For some reason most people seem to jump right to the test table and the tests they think apply, then dive into the implementation details, while the standard speaks a lot and in detail about "an evaluation" (not necessarily testing) and the risk management process context.
I agree. But, similar to the way that "voluntary" standards are pretty much required at this point, the reason companies adopt this approach is that it's the surest path to passing regulatory hurdles without too much headache or uncertainty.

If a Notified Body or FDA 510(k) reviewer sees that you applied the table in Annex A of ISO 10993-1 to determine the appropriate tests, and executed them, this is a much more certain approach than justifying why you didn't apply the tests.

I wish it were otherwise, but given the uncertainty of what individual auditors/reviewers will accept as justification, just doing the tests is often the simplest path.
 

Marcelo

Inactive Registered Visitor
#7
I wish it were otherwise, but given the uncertainty of what individual auditors/reviewers will accept as justification, just doing the tests is often the simplest path.
Until it's not enough and then another problem is created. I do understand why so many manufacturers prefer to "let's pass the audit"instead of "let's do the right thing" approach - and most even think that "pass the audit" means they are doing the right thing due to lack of knowledge, but 99% of the time it's easier to to the right thing (and it will be always in conformity, while the "pass the audit" solution may pass one or more time, but it may also not).
 

Ronen E

Problem Solver
Staff member
Moderator
#8
this is a much more certain approach than justifying why you didn't apply the tests.
The standard doesn't speak of "justifying why you didn't test". It speaks of collating and analysing all the relevant available information to reach relevant conclusions about biological safety. When this is not done, why shouldn't a reviewer object?...

Indsutry should not complain - it consistently seeks the minimal effort path (and below) so no wonder regulators adopt a mechanistic (rather than a thoughtful) approach. This trend goes well beyond biocompatibility.
 
Thread starter Similar threads Forum Replies Date
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
W Biocompatibility of Implantable Component - What testing, if any? Other Medical Device and Orthopedic Related Topics 5
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
Kuldeep Singh Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3
C Biocompatibility Evaluation Testing on Single Use Tube Sets Other Medical Device Related Standards 9
I Biocompatibility Testing Requirements for a Class I device - Does not contact patient 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 1
S Biocompatibility - Complement System Testing US Food and Drug Administration (FDA) 1
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22
T Animals for biocompatibility testing? Other Medical Device Related Standards 10
V Biocompatibility testing centre in Montreal QC ? Other Medical Device and Orthopedic Related Topics 3
A Biocompatibility testing & Registration in China ISO 13485:2016 - Medical Device Quality Management Systems 5
M Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 3
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7
J Biocompatibility tests in AAA LAC Laboratory ISO 13485:2016 - Medical Device Quality Management Systems 6
B Biocompatibility for Packaging Materials Other Medical Device Related Standards 3
S Laminaria - Is a Biocompatibility Study Required? EU Medical Device Regulations 6
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
S Laminaria - Biocompatibility Study? Imported Legacy Blogs 1

Similar threads

Top Bottom